@Article{info:doi/10.2196/67764,
author="Cao, Yuan
and Shi, Yuanxin
and Low, Wing Debbie Chi
and Shek, L. Daniel T.
and Shum, K. David H.
and Tanksale, Radhika
and Dingle, Genevieve",
title="Using Music to Promote Hong Kong Young People's Emotion Regulation and Reduce Their Mood Symptoms and Loneliness: Protocol for a Pilot Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2025",
month="Apr",
day="16",
volume="14",
pages="e67764",
keywords="youth",
keywords="adolescents",
keywords="adolescence",
keywords="teens",
keywords="teenagers",
keywords="music",
keywords="moods",
keywords="mood symptoms",
keywords="loneliness",
keywords="emotion regulation",
keywords="emotions",
keywords="Hong Kong",
keywords="mental health",
keywords="mental illnesses",
keywords="mental disorders",
keywords="randomized controlled trial",
keywords="RCTs",
keywords="protocol",
abstract="Background: Mental health needs in the community surged during the pandemic, with concerning reports of increased negative mood symptoms among youth. At the same time, preventive psychoeducational interventions were insufficient within frontline youth mental health services in Hong Kong, and research specifically addressing youth loneliness remained limited on an international scale. Given the association between loneliness and other mental health symptoms, psychoeducational programs that empower adolescents to cope with emotions may help address both the research gap and local demand. As such, Tuned In, a previously validated intervention program originally developed in Australia, was introduced to the local context. Cultural adaptations and an added focus on loneliness were incorporated into the project to enhance its acceptability and test its effectiveness. Objective: This study aims to evaluate an adapted version of the Tuned In music-based psychoeducation program, designed to reduce loneliness, depression, and anxiety symptoms among young people in Hong Kong by enhancing their emotion regulation skills. Methods: Participants aged 16-19 years will be randomly assigned to either the experimental or control group. The experimental group will receive an online, group-based psychoeducation program focused on emotion recognition and management, delivered weekly over 4 consecutive weeks. The intervention is grounded in Russell's emotion circumplex model and music psychology, and program content included: The 2D model and characteristics of emotions from different quadrants (session 1); happiness and loneliness (session 2); high-arousal and negative-valence emotions, for example, stress and anxiety (sessions 3); and anxiety, perfectionism, and a celebration of achievement (session 4). Both therapist- and participant-selected music will be used in the intervention to provide a rich repertoire for group discussion, psychoeducation, reflection, and the practice of social skills. The main outcome measures will be assessed using the Emotion Regulation Questionnaire, the Difficulties in Emotion Regulation Scale, the Depression Anxiety Stress Scale, and the De Jong Gierveld Loneliness Scale. Feedback on the project arrangement will be gathered through qualitative input. A mixed methods analysis will be conducted following data collection. Results: The project was successfully funded in February 2023 by the Health and Medical Research Fund in Hong Kong and commenced in August 2023. As of September 16, 2024, a total of 316 completed questionnaires had been received through Qualtrics for screening purposes, with 89 participants deemed eligible for the program. The project is scheduled to conclude in August 2025, with results to be published thereafter. Conclusions: Participants are expected to show improvements in emotion regulation, along with reductions in mood symptoms and loneliness, following the intervention. Trial Registration: ClinicalTrials.gov NCT06147297; https://clinicaltrials.gov/study/NCT06147297 International Registered Report Identifier (IRRID): DERR1-10.2196/67764 ",
doi="10.2196/67764",
url="https://www.researchprotocols.org/2025/1/e67764"
}


@Article{info:doi/10.2196/64023,
author="Ban, Yuki
and Waki, Kayo
and Nakada, Ryohei
and Isogawa, Akihiro
and Miyoshi, Kengo
and Waki, Hironori
and Kato, Shunsuke
and Sawaki, Hideaki
and Murata, Takashi
and Hirota, Yushi
and Saito, Shuichiro
and Nishikage, Seiji
and Tone, Atsuhito
and Seno, Mayumi
and Toyoda, Masao
and Kajino, Shinichi
and Yokota, Kazuki
and Tsurutani, Yuya
and Yamauchi, Toshimasa
and Nangaku, Masaomi
and Ohe, Kazuhiko",
title="Efficacy of a Personalized Mobile Health Intervention (BedTime) to Increase Sleep Duration Among Short-Sleeping Patients With Type 2 Diabetes: Protocol for a Pilot Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2025",
month="Apr",
day="14",
volume="14",
pages="e64023",
keywords="digital therapeutics",
keywords="behavior change",
keywords="Theory of Planned Behavior",
keywords="sleep duration",
keywords="type 2 diabetes",
keywords="randomized controlled trial",
abstract="Background: A strong association exists between sleep duration and glycemic control in patients with type 2 diabetes (T2D), yet convincing evidence of a causal link remains lacking. Improving sleep is increasingly emphasized in clinical T2D treatment guidance, highlighting the need for effective, scalable sleep interventions that can affordably serve large populations through mobile health (mHealth). Objective: This study aims to pilot an intervention that extends sleep duration by modifying bedtime behavior, assessing its efficacy among short-sleeping (?6 hours per night) patients with T2D, and establishing robust evidence that extending sleep improves glycemic control. Methods: This randomized, single-blinded, multicenter study targets 70 patients with T2D from 9 institutions in Japan over a 12-week intervention period. The sleep extension intervention, BedTime, is developed using the Theory of Planned Behavior (TPB) and focuses on TPB's constructs of perceived and actual behavioral control (ABC). The pilot intervention combines wearable actigraphy devices with SMS text messaging managed by human operators. Both the intervention and control groups will use an actigraphy device to record bedtime, sleep duration, and step count, while time in bed (TIB) will be assessed via sleep diaries. In addition, the intervention group will receive weekly bedtime goals, daily feedback on their bedtime performance relative to those goals, identify personal barriers to an earlier bedtime, and select strategies to overcome these barriers. The 12-week intervention period will be followed by a 12-week observational period to assess the sustainability of the intervention's effects. The primary outcome is the between-group difference in the change in hemoglobin A1c (HbA1c) at 12 weeks. Secondary outcomes include other health measures, sleep metrics (bedtime, TIB, sleep duration, total sleep time, and sleep quality), behavioral changes, and assessments of the intervention's usability. The trial commenced on February 8, 2024, and is expected to conclude in February 2025. Results: Patient recruitment ended on August 29, 2024, with 70 participants enrolled. The intervention period concluded on December 6, 2024, and the observation period ended on February 26, 2025, with 70 participants completing the observation period. The data analysis is currently underway, and results are expected to be published in July 2025. Conclusions: This trial will provide important evidence on the causal link between increased sleep duration and improved glycemic control in short-sleeping patients with T2D. It will also evaluate the efficacy of our bedtime behavior change intervention in extending sleep duration, initially piloted with human operators, with the goal of future implementation via an mHealth smartphone app. If proven effective, this intervention could be a key step toward integrating sleep-focused mHealth into the standard treatment for patients with T2D in Japan. Trial Registration: Japan Registry of Clinical Trials jRCT1030230650; https://jrct.niph.go.jp/latest-detail/jRCT1030230650 International Registered Report Identifier (IRRID): DERR1-10.2196/64023 ",
doi="10.2196/64023",
url="https://www.researchprotocols.org/2025/1/e64023"
}


@Article{info:doi/10.2196/66298,
author="Halicki-Asakawa, Aman{\'e}
and Mocci, Julia
and Libben, Maya",
title="Mobile App--Delivered Motivational Interviewing for Women on Eating Disorder Treatment Waitlists (MI-Coach: ED): Protocol for an App Development and Pilot Evaluation",
journal="JMIR Res Protoc",
year="2025",
month="Apr",
day="10",
volume="14",
pages="e66298",
keywords="eating disorders",
keywords="motivational interviewing",
keywords="treatment barriers",
keywords="digital interventions",
keywords="pilot test",
keywords="protocol",
keywords="eating disorder",
keywords="eating",
keywords="woman",
keywords="women",
keywords="female",
keywords="Canada",
keywords="Canadian",
keywords="mobile apps",
keywords="mobile health",
keywords="mHealth",
keywords="app development",
keywords="app-based",
keywords="mental health",
keywords="pilot evaluation",
keywords="waitlists",
keywords="mixed methods",
keywords="feasibility",
keywords="acceptability",
keywords="service delivery",
abstract="Background: A significant increase in eating disorder (ED) service waitlists has been observed in the past several years, exacerbating existing barriers to care (eg, long waitlists, scarcity of treatment centers, and positive beliefs surrounding pathology). Given that treatment delays have important clinical correlates (eg, entrenchment of ED pathology), exploring new methods of mental health service delivery for this population is of critical concern. App-based motivational interviewing (MI) delivered prior to the start of treatment has the potential to improve accessibility by simultaneously addressing structural (eg, travel costs) and individual (eg, low motivation) barriers to care. Despite the potential benefits, there remains a lack of empirically validated, ED-specific MI-based mobile apps. Evaluating the feasibility and acceptability of such interventions is a crucial first step before progressing to full-scale efficacy trials. Objective: This multiphasic mixed methods study aims to develop and assess the feasibility and acceptability of MI-Coach: ED, a novel app designed to increase motivation among women waitlisted for ED treatment. Specifically, this study seeks to determine participant engagement levels, user satisfaction, and perceived usability of the app, as well as to explore preliminary trends in motivation and ED-related symptoms following app use. Methods: Phase I adapted the content and interface of an existing app based on evidence-based principles (MI-Coach) for an ED population. Phase II pilot tested the app through a pre-post evaluation. Participants (n=30) aged 18 years and older were recruited from ED treatment waitlists in British Columbia, Canada. After completing baseline assessments evaluating demographic and clinical variables (eg, motivation, eating pathology, depression, and anxiety symptoms), participants were provided access to MI-Coach: ED for 1 month. Participants completed postintervention assessments and provided both quantitative and qualitative feedback on the app. Feasibility will be evaluated through the total number of participants recruited, study dropout rates, and engagement indicators (eg, modules completed) within the app. Acceptability will be assessed through self-report measures and semistructured exit interviews, which will explore user experiences, perceived benefits, and barriers to app engagement. Additionally, exploratory analyses will examine changes in motivation and ED symptoms before and after the intervention. Results: The MI-Coach: ED app has been developed, and recruitment was initiated in November 2022 and terminated in May 2024. Results are being analyzed and will be submitted for publication in May 2025. Conclusions: This study has the potential to transform ED service delivery and mitigate the impacts of existing treatment barriers for this population. By leveraging a digital MI-based intervention, MI-Coach: ED could serve as a scalable and accessible pretreatment tool, helping to bridge the gap between initial help-seeking and formal ED treatment. Findings from this study will inform the refinement of the intervention and recruitment strategies for future large-scale efficacy trials. International Registered Report Identifier (IRRID): DERR1-10.2196/66298 ",
doi="10.2196/66298",
url="https://www.researchprotocols.org/2025/1/e66298"
}


@Article{info:doi/10.2196/65770,
author="Schuler, R. Kaitlyn
and Ong, Triton
and Welch, M. Brandon
and Craggs, G. Jason
and Bunnell, E. Brian",
title="Examining a Telemedicine-Based Virtual Reality Clinic in Treating Adults With Specific Phobia: Protocol for a Feasibility Randomized Controlled Efficacy Trial",
journal="JMIR Res Protoc",
year="2025",
month="Apr",
day="10",
volume="14",
pages="e65770",
keywords="virtual reality",
keywords="exposure therapy",
keywords="phobias",
keywords="telemedicine",
keywords="telemental health",
keywords="tele-VR",
keywords="immersive simulations",
abstract="Background: Virtual reality (VR) has strong potential to enhance the effectiveness of telemental health care (TMH) by providing accessible, personalized treatment from home. While there is ample research supporting VR for in-person treatment, there is only preliminary data on the efficacy of telemedicine-based VR. Furthermore, the majority of VR apps used in therapy are not designed for mental health care. VR has the potential to enhance TMH through innovative technology solutions designed specifically for the enhancement of remotely delivered evidence-based practices. This feasibility randomized controlled efficacy trial aims to fill both of these gaps by piloting a novel telemedicine-based VR app (Doxy.me VR) equipped with animal phobia exposure stimuli. Objective: This is a feasibility randomized controlled efficacy trial comparing exposure therapy via a telemedicine-based VR clinic versus standard TMH with adults with an intense fear of dogs, snakes, or spiders. The primary objective is to assess the feasibility of a fully powered trial. The secondary objective is to conduct a preliminary examination of clinical outcomes (eg, specific phobia symptoms). Methods: This single-site trial will enroll a minimum of 30 and a maximum of 60 adults with self-reported fear of dogs, snakes, or spiders. Potential participants will be recruited through clinical trial and research recruitment websites and posting flyers. All self-report assessments and homework will be partially automated using REDCap (Research Electronic Data Capture; Vanderbilt University) forms and surveys, but the baseline assessment of phobia symptoms and exposure intervention will be administered by the study therapist. Results: The feasibility of the proposed trial methodology will be assessed using enrollment, retention, assessment completion, and treatment protocol fidelity benchmarks. Between-group differences in specific phobia, anxiety, and depression symptoms while covarying for pretreatment scores, will be conducted using repeated measures ANOVA along with differences in therapeutic alliance and presence. Data obtained from these analyses will inform power analyses for a fully powered efficacy trial. In total, 54 participants were randomized between October 25, 2023, and July 26, 2024 (Doxy.me VR n=28 and TMH n=26). Data analysis will be completed and submitted by the end of the second quarter of 2025. Conclusions: This feasibility randomized controlled trial comparing Doxy.me VR versus TMH aims to enhance the delivery of evidence-based treatments via telemedicine and reduce barriers to remotely delivered exposure therapy. This feasibility trial will be followed by a fully powered efficacy trial on telemedicine-based VR for animal phobias. Trial Registration: ClinicalTrials.gov NCT06302868; https://clinicaltrials.gov/study/NCT06302868 International Registered Report Identifier (IRRID): DERR1-10.2196/65770 ",
doi="10.2196/65770",
url="https://www.researchprotocols.org/2025/1/e65770"
}


@Article{info:doi/10.2196/60527,
author="Michaud, Tzeyu
and Puga, Troy
and Archer, Rex
and Theye, Elijah
and Zagurski, Cleo
and Estabrooks, Paul
and Dai, Daisy Hongying",
title="Enhancing Text Message Support With Media Literacy and Financial Incentives for Vaping Cessation in Young Adults: Protocol for a Pilot Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2025",
month="Feb",
day="21",
volume="14",
pages="e60527",
keywords="contingency management",
keywords="e-cigarettes",
keywords="social support",
keywords="youth",
keywords="electronic health record",
keywords="opt-in",
keywords="recruitment",
keywords="tobacco marketing",
keywords="cessation",
keywords="peer support",
keywords="young adult",
keywords="feasibility",
keywords="public health",
abstract="Background: The persistent high prevalence of e-cigarette use among young adults remains a significant public health concern, with limited evidence and guidance on effective vaping cessation programs targeting this population. Objective: This study aims to outline the study design and protocol of a pilot randomized controlled trial aimed at investigating feasibility and assessing whether media literacy education or financial incentives enhance the effectiveness of evidence-based text message support in promoting vaping abstinence among young adult e-cigarette users. Methods: The pilot study uses a 4-arm (1:1:1:1) randomized controlled trial design to assess the potential impact of different combinations of media literacy education, financial incentives, and text message support on vaping abstinence over a 3-month period. The first month serves as a preparatory phase for quitting, followed by 2 months focused on abstinence. A total of 80 individuals, aged 19-29 years, who have used e-cigarettes within the past 30 days, have internet access, and express interest in quitting vaping within the next 30 days, will be enrolled. Eligible individuals will be randomized into one of the four study groups: (1) Text Message, (2) Media Literacy, (3) Financial Incentive, and (4) Combined. All participants, regardless of group assignment, will receive text message support. Participants will be followed for 12 weeks, with abstinence status assessed at week 12, as well as during remote check-ins at weeks 6, 8, and 10. Feasibility measures include recruitment rate, reach, engagement, and retention. Other outcomes of interest include self-reported 7-day abstinence and changes in nicotine dependence and media literacy scores. Exit interviews will be conducted with those who complete the study to explore facilitators of and barriers to participation and engagement in vaping cessation, which will inform future program refinement and uptake. Results: Recruitment for the study commenced in December 2023 and concluded in August 2024. A total of 40 participants were randomized into these groups: 9 for Text Message, 11 for Media Literacy, 10 for Financial Incentive, and 10 for the Combined group. The final assessment was completed in November 2024, and analyses are currently ongoing. Conclusions: The findings from this trial could provide valuable insights into the design and uptake of vaping cessation strategies among the young adult population. Trial Registration: ClinicalTrials.gov NCT05586308; https://clinicaltrials.gov/study/NCT05586308 International Registered Report Identifier (IRRID): DERR1-10.2196/60527 ",
doi="10.2196/60527",
url="https://www.researchprotocols.org/2025/1/e60527"
}


@Article{info:doi/10.2196/64465,
author="Jornkokgoud, Khanitin
and Makmee, Pattrawadee
and Wongupparaj, Peera
and Grecucci, Alessandro",
title="Tablet- and Group-Based Multicomponent Cognitive Stimulation for Older Adults With Mild Cognitive Impairment: Single-Group Pilot Study and Protocol for Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2025",
month="Feb",
day="21",
volume="14",
pages="e64465",
keywords="computerized cognitive stimulation",
keywords="multisensory integration",
keywords="cognitive decline",
keywords="aging",
keywords="electroencephalography",
keywords="randomized controlled trial",
keywords="RCT",
keywords="protocol",
keywords="cognitive stimulation",
keywords="mild cognitive impairment",
keywords="cognitive",
keywords="cognition",
keywords="cognitive simulation therapy",
keywords="CST",
keywords="MCI",
keywords="tablet",
keywords="effectiveness",
keywords="pilot study",
keywords="neuropsychological tests",
keywords="behavioral",
keywords="emotional",
abstract="Background: Cognitive stimulation therapy is a group-based psychological treatment for people with dementia as well as those with mild cognitive impairment (MCI) and is shown to improve both cognition and quality of life. Previous studies have indicated the potential to benefit from the use of technological devices in group interventions. Objective: The pilot study aimed to assess the effectiveness of a tablet- and group-based multicomponent cognitive stimulation therapy (MCST) for enhancing cognitive functions among older adults with MCI. The following study aims to report the protocol for a trial evaluating whether the MCST program is affecting individuals with MCI. Methods: In the first study, 30 individuals with MCI participated in 10 sessions of the tablet- and group-based MCST group. A subsequent protocol study will compare tablet-based MCST, tablet-based cognitive stimulation therapy, and control groups among 93 individuals with MCI. All participants will be recruited from older adults living in semiurban communities. Intervention groups will be facilitated by trained therapists, nurses, or psychologists. The study will be assessed by a pre- and posttest evaluation, including computer-based neuropsychological tests and electroencephalography assessment. The effects of several indicators, such as cognitive functions, behavioral, and emotional, will be analyzed as being indexed by their neurophysiological data. Results: The pilot study showed significant cognitive improvement (P<.001), reduced depression (P=.002), and decreased state anxiety (P=.001) post intervention. Quality of life remained unchanged (P=.18). The randomized controlled trial study was funded in March 2023. Enrolling began in August 2023 and was completed in December 2023. The data analysis was started, and the results are expected to be published by mid- to late-2025. Conclusions: The study is the first tablet-group--based MCST for older adults with MCI in middle-income countries. It will provide deeper insight into participants' neuropsychological data, thus identifying specific processes underlying physiologically measured positive outcomes. Furthermore, the project will deliver solid and integrative results to mental health professionals in terms of knowledge and guidance for implementing the tablet- and group-based MCST in people with MCI. Trial Registration: Thai Clinical Trials Registry TCTR20230829004; https://tinyurl.com/3wuaue3e International Registered Report Identifier (IRRID): DERR1-10.2196/64465 ",
doi="10.2196/64465",
url="https://www.researchprotocols.org/2025/1/e64465"
}


@Article{info:doi/10.2196/64560,
author="Zhao, Jing
and Yasunaga, Akitomo
and Kaczynski, T. Andrew
and Park, Hyuntae
and Luo, Yufeng
and Li, Jiuling
and Shibata, Ai
and Ishii, Kaori
and Yano, Shohei
and Oka, Koichiro
and Koohsari, Javad Mohammad",
title="At-Home Immersive Virtual Reality Exergames to Reduce Cardiometabolic Risk Among Office Workers: Protocol for a Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2025",
month="Jan",
day="20",
volume="14",
pages="e64560",
keywords="metabolic syndrome",
keywords="noncommunicable diseases",
keywords="active video game",
keywords="interactive virtual reality environment",
keywords="physical activity",
keywords="workplace health",
keywords="at-home intervention",
abstract="Background: The worldwide rise in the prevalence of noncommunicable diseases has increased the recognition of the need to identify modifiable risk factors for preventing and managing these diseases. The office worker, as a representative group of physically inactive workers, is exposed to risk factors for metabolic syndrome, which is a primary driver of noncommunicable diseases. The use of virtual reality (VR) exergames may offer a potential solution to the problem of increasing noncommunicable disease prevalence, as it can help individuals increase their physical activity levels while providing a more immersive experience. Objective: This exploratory study aims to examine the interventional efficacy of at-home immersive VR exergames on metabolic syndrome biomarkers among office workers. Additionally, it seeks to investigate the impacts of at-home immersive VR exergames on the active and sedentary behaviors of office workers. Methods: A 3-arm, single-blinded pilot randomized controlled trial will be conducted to examine the therapeutic effects of at-home immersive VR exergames. A total of 120 Chinese office workers, engaging in less than 150 minutes per week of moderate to vigorous intensity physical activity, will be recruited via a convenience sampling method. The participants, who will be tested over a 12-week period, will be randomly assigned to one of three groups: (1) the VR exergame intervention group, (2) the regular physical activity control group, and (3) the nonexercise control group. Throughout the 12-week trial, three categories of variables will be collected across the three groups: clinical risk factors associated with metabolic syndrome, active and sedentary behaviors, and demographics. To analyze variance among the groups, a mixed linear model will be applied to assess the efficacy of each group. Differences in metabolic syndrome clinical risk factors among all groups will be used to evaluate the effects of at-home immersive VR exergames. Changes in active and sedentary behaviors will also be used to determine the impacts of VR exergames on metabolic syndrome. Results: The ethics committee of Guangzhou University, China, approved this study on September 25, 2024. Participant recruitment will begin in early 2025 and continue for approximately 3 months. Data will be analyzed after the 12-week trial is completed, with full results expected to be presented in early 2026. Conclusions: This study explores an emerging topic by applying an at-home immersive VR exergame intervention, potentially contributing to understanding the effects of an exergame program on metabolic syndrome risk among office workers. Trial Registration: ClinicalTrials.gov NCT06556784; https://clinicaltrials.gov/study/NCT06556784 International Registered Report Identifier (IRRID): PRR1-10.2196/64560 ",
doi="10.2196/64560",
url="https://www.researchprotocols.org/2025/1/e64560"
}


@Article{info:doi/10.2196/55633,
author="Zhang, Hanxi
and Han, Jing
and Su, Ye
and Zhao, Hongxin
and Zhang, Fujie",
title="Virtual Reality--Based Psychological Intervention for Young Adults Living With HIV: Protocol for a Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2025",
month="Jan",
day="10",
volume="14",
pages="e55633",
keywords="HIV",
keywords="young adults",
keywords="mental health",
keywords="virtual reality",
keywords="VR",
keywords="psychological intervention",
keywords="depression",
keywords="anxiety",
keywords="living with HIV",
keywords="privacy",
keywords="intervention",
abstract="Background: Young adults (15-24 years old) living with HIV may experience pressure both from HIV infection and social role change problems, resulting in a series of psychological problems such as depression and anxiety. Effective psychological intervention can improve their mental health and quality of life. Objective: The study aims to explore the effectiveness of VR-based mental intervention on young adults living with HIV. The application and advantages of virtual reality (VR) in children's psychotherapy provide new ideas for psychological intervention for young adults living with HIV. Methods: We use the qualitative interviews and questionnaire results as well as guided by classical psychotherapy to create a personalized psychological intervention system for young adults living with HIV through VR technology, which is based on the long-term AIDS treatment cohort and infectious diseases cohort of children. We use the mental scales and biochemical indexes as the outcomes, conducting a prospective randomized controlled trial to verify the feasibility and effectiveness of the VR psychological intervention system. Results: The study began enrollment in September 2023. To date, 160 participants have finished the baseline questionnaires. Conclusions: The study results might provide a scientific basis for accurate psychological treatment among young adults living with HIV in the future. International Registered Report Identifier (IRRID): DERR1-10.2196/55633 ",
doi="10.2196/55633",
url="https://www.researchprotocols.org/2025/1/e55633"
}


@Article{info:doi/10.2196/56693,
author="Dantes, Rasben Gede
and Asril, Maylani Nice
and Liem, Andrian
and Suwastini, Arie Ni Komang
and Keng, Shian-Ling
and Mahayanti, Surya Ni Wayan",
title="Brief Mobile App--Based Mindfulness Intervention for Indonesian Senior High School Teachers: Protocol for a Pilot Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2024",
month="Oct",
day="23",
volume="13",
pages="e56693",
keywords="digital mental health",
keywords="telemedicine",
keywords="anxiety",
keywords="stress",
keywords="self-efficacy",
keywords="life satisfaction",
keywords="self-compassion",
keywords="mindfulness",
keywords="feasibility study",
keywords="mobile app",
keywords="mindfulness-based stress reduction",
keywords="stress management",
abstract="Background: The COVID-19 pandemic has increased the level of anxiety among Indonesian senior high school teachers, who face challenges to treat their mental disorder symptoms that arise during their working hours, as mental health services in Indonesia are limited. Therefore, it is vital to equip schoolteachers in Indonesia with early interventions that are easily available, private, and affordable, and 1 feasible approach is to deploy a smartphone mobile app. Objective: The objectives of this study are (1) to evaluate the feasibility of a brief mindfulness--based mobile app (BM-MA) for Indonesian senior high school teachers experiencing anxiety and stress and (2) to examine the effects of using the BM-MA on anxiety, stress, life satisfaction, self-efficacy, trait mindfulness, self-compassion, and physical and social dysfunction among the participants. Methods: We followed the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 statement for this feasibility randomized controlled trial (RCT) protocol. A total of 60 Indonesian senior high school teachers were recruited for this study and randomly assigned to either the intervention group (BM-MA) or a wait-list control group (CG) in a 1:1 ratio. The BM-MA group was required to engage in mindfulness practices using the app for 10-20 minutes per day for 3 weeks. All participants were assessed with a battery of self-report measures at baseline, postintervention, and at 1-month follow-up. Validated scales used to measure the outcome variables of interest included the Satisfaction With Life Scale (SLS), the Teachers' Sense of Efficacy Scale (TSES), the Self-Compassion Scale---Short Form (SCS-SF), Generalized Anxiety Disorder-7 (GAD-7), General Health Questionnaire-12 (GHQ-12), and the Five Facet Mindfulness Questionnaire (FFMQ). The practicality and acceptability of the app will be evaluated using the Client Satisfaction Questionnaire-8 (CSQ-8) and structured qualitative interviews. Data from the interviews will be analyzed with the deductive thematic analysis framework as a process of qualitative inquiry. Repeated measures ANOVA with groups (intervention vs control) as a between-subject factor and time as a within-subject factor (baseline, postintervention, and 1-month follow-up) will be used to examine the effects of the BM-MA on the outcome variables. The data will be analyzed using an intent-to-treat approach and published in accordance with CONSORT (Consolidated Standards of Reporting Trials) recommendations. Results: Participants were recruited in December 2023, and this pilot RCT was conducted from January through March 2024. Data analysis was conducted from March through May 2024. The results of this study are expected to be published in December 2024. The trial registration of this protocol was submitted to the Chinese Clinical Trial Registry. Conclusions: This study aims to determine the feasibility and efficacy of the BM-MA, a digital mental health intervention developed using an existing mindfulness-based app, and assess its potential for widespread use. Trial Registration: Chinese Clinical Trial Registry ChiCTR2300068085; https://tinyurl.com/2d2x4bxk International Registered Report Identifier (IRRID): DERR1-10.2196/56693 ",
doi="10.2196/56693",
url="https://www.researchprotocols.org/2024/1/e56693"
}


@Article{info:doi/10.2196/60769,
author="Mak, Selene
and Ash, Garrett
and Liang, Li-Jung
and Der-McLeod, Erin
and Ghadimi, Sara
and Kewalramani, Anjali
and Naeem, Saadia
and Zeidler, Michelle
and Fung, Constance",
title="Testing a Consumer Wearables Program to Promote the Use of Positive Airway Pressure Therapy in Patients With Obstructive Sleep Apnea: Protocol for a Pilot Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2024",
month="Sep",
day="19",
volume="13",
pages="e60769",
keywords="sleep apnea",
keywords="consumer wearables",
keywords="adherence",
keywords="self-management",
keywords="mobile phone",
abstract="Background: Although positive airway pressure (PAP) therapy is considered first-line treatment for obstructive sleep apnea (OSA), nonadherence is common. Numerous factors influence PAP use, including a belief that the therapy is important and effective. In theory, providing information to patients about their blood oxygen levels during sleep (which may be low when PAP is not used), juxtaposed to information about their PAP use, may influence a patient's beliefs about therapy and increase PAP use. With the advent of consumer wearable smartwatches' blood oxygen saturation monitoring capability (and the existing routine availability of PAP use data transmitted via modem to clinical dashboards), there is an opportunity to provide this combination of information to patients. Objective: This study aims to test the feasibility, acceptability, and preliminary efficacy of the Chronic Care Management With Wearable Devices in Patients Prescribed Positive Airway Pressure Therapy (mPAP), a program that augments current PAP therapy data with consumer-grade wearable device to promote self-management of PAP therapy for OSA in a pilot randomized waitlist-controlled clinical trial. Methods: This is a single-blinded randomized controlled trial. We will randomize 50 individuals with a history of OSA, who receive care from a Department of Veterans Affairs medical center in the Los Angeles area and are nonadherent to prescribed PAP therapy, into either an immediate intervention group or a waitlist control group. During a 28-day intervention, the participants will wear a study-provided consumer wearable device and complete a weekly survey about their OSA symptoms. A report that summarizes consumer wearable--provided oxygen saturation values, PAP use derived from modem data, and patient-reported OSA symptoms will be prepared weekly and shared with the patient. The immediate intervention group will begin intervention immediately after randomization (T1). Assessments will occur at week 5 (T3; 1 week after treatment for the immediate intervention group and repeat baseline for the waitlist control group) and week 11 (T5; follow-up for the immediate intervention group and 1 week after treatment for the waitlist control group). The primary outcome will be the change in 7-day PAP adherence (average minutes per night) from T1 to T3. The primary analysis will be a comparison of the primary outcome between the immediate intervention and the waitlist control groups (intention-to-treat design), using a 2-sample, 2-sided t test on change scores (unadjusted). Results: Recruitment began in October 2023. Data analysis is expected to begin in October 2024 when all follow-ups are complete, and a manuscript summarizing trial results will be submitted following completion of data analysis. Conclusions: Findings from the study may provide additional insights on how patients with OSA might use patient-generated health data collected by consumer wearables to inform self-management of OSA and possibly increase their use of PAP therapy. Trial Registration: ClinicalTrials.gov NCT06039865; https://clinicaltrials.gov/study/NCT06039865 International Registered Report Identifier (IRRID): DERR1-10.2196/60769 ",
doi="10.2196/60769",
url="https://www.researchprotocols.org/2024/1/e60769",
url="http://www.ncbi.nlm.nih.gov/pubmed/39207912"
}


@Article{info:doi/10.2196/53727,
author="Egan, Kieren
and Macdonald, Bradley
and Hodgson, William
and Kirk, Alison
and Fawcett, Barbara
and Dunlop, D. Mark
and Maguire, Roma
and Flynn, Greg
and Stott, Joshua
and Windle, Gill",
title="Physical Activity Mobile App (CareFit) for Informal Carers of People With Dementia: Protocol for a Feasibility and Adaptation Study",
journal="JMIR Res Protoc",
year="2024",
month="Sep",
day="12",
volume="13",
pages="e53727",
keywords="carers",
keywords="dementia",
keywords="physical activity",
keywords="sedentary",
keywords="cross platform app",
keywords="caregivers",
keywords="mobile phone",
abstract="Background: Physical activity is a critical component of both well-being and preventative health, reducing the risk of both chronic mental and physical conditions and early death. Yet, there are numerous groups in society who are not able to undertake as much physical activity as they would like to. This includes informal (unpaid) carers, with the United Kingdom national survey data suggesting that 81\% would like to do more physical activity on a regular basis. There is a clear need to develop innovations, including digital interventions that hold implementation potential to support regular physical activity in groups such as carers. Objective: This study aims to expand and personalize a cross-platform digital health app designed to support regular physical activity in carers of people with dementia for a period of 8 weeks and evaluate the potential for implementation. Methods: The CareFit for dementia carers study was a mixed methods co-design, development, and evaluation of a novel motivational smartphone app to support home-based regular physical activity for unpaid dementia carers. The study was planned to take place across 16 months in total (September 1, 2022, to December 31, 2023). The first phase included iterative design sprints to redesign an initial prototype for widespread use, supported through a bespoke content management system. The second phase included the release of the ``CareFit'' app across Scotland through invitations on the Apple and Google stores where we aimed to recruit 50 carers and up to 20 professionals to support the delivery in total. Partnerships for the work included a range of stakeholders across charities, health and social care partnerships, physical activity groups, and carers' organizations. We explored the implementation of CareFit, guided by both Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) and the Complex Intervention Frameworks. Results: Project processes and outcomes were evaluated using mixed methods. The barriers and enablers for professional staff to signpost and use CareFit with clients were assessed through interviews or focus groups and round stakeholder meetings. The usability of CareFit was explored through qualitative interviews with carers and a system usability scale. We examined how CareFit could add value to carers by examining ``in-app'' data, pre-post questionnaire responses, and qualitative work, including interviews and focus groups. We also explored how CareFit could add value to the landscape of other online resources for dementia carers. Conclusions: Results from this study will contribute new knowledge including identifying (1) suitable pathways to identify and support carers through digital innovations; (2) future design of definitive studies in carer populations; and (3) an improved understanding of the Reach, Effectiveness, Adoption, Implementation, and Maintenance across a range of key stakeholders. International Registered Report Identifier (IRRID): DERR1-10.2196/53727 ",
doi="10.2196/53727",
url="https://www.researchprotocols.org/2024/1/e53727"
}


@Article{info:doi/10.2196/49922,
author="Ruslin, Muhammad
and Hamrun, Nurlindah
and Tajrin, Andi
and Yusuf, Hajrah Andi Sitti
and Nurrahma, Rifaat
and Natsir-Kalla, Sabrina Diandra
and Ariestiana, Yoanita Yossy
and Nur Anam, Mukhtar
and Liu, Chung-Ming
and Ou, Keng-Liang",
title="Feasibility and Preliminary Efficacy of $\alpha$--Calcium Sulfate Hemihydrate in Socket Preservation: Protocol for a Pilot Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2024",
month="Jul",
day="19",
volume="13",
pages="e49922",
keywords="$\alpha$--calcium sulfate hemihydrate",
keywords="$\alpha$-CSH",
keywords="bone graft",
keywords="bone regeneration",
keywords="socket preservation",
keywords="pilot",
keywords="feasibility",
keywords="efficacy",
keywords="impacted tooth",
keywords="tooth extraction",
keywords="radiographic imaging",
keywords="bone",
keywords="dentist",
keywords="dentistry",
keywords="dental",
keywords="bone resorption",
keywords="graft",
keywords="bone loss",
keywords="alveolar bone",
keywords="regeneration",
abstract="Background: Tooth extraction procedures often lead to bone resorption, which can have adverse effects on the dimensions of the alveolar ridge. Research has shown that socket preservation techniques using bone graft substitutes can effectively minimize early bone loss in such cases. $\alpha$--calcium sulfate hemihydrate ($\alpha$-CSH) has garnered significant attention as a potential bone graft material due to its favorable properties, including osteoconductivity, angiogenic potential, and biocompatibility. Considering these facts, we developed a preliminary protocol for applying $\alpha$-CSH in addressing alveolar bone loss following tooth extraction. Objective: This research's general objective is to evaluate the feasibility and initial effectiveness of $\alpha$-CSH as bone-inducing graft material for socket preservation after tooth extraction. Methods: This preliminary clinical trial will involve 30 fresh extraction sockets from individuals aged 18-35 years. The participants will be divided into 2 groups: one group will receive $\alpha$-CSH graft material after tooth extraction for socket preservation, while the other group will not receive any graft material. Throughout the study, the participants will be closely monitored for safety measures, which will include clinical examinations, radiographic imaging, and blood tests. Radiographic imaging will be used extensively to assist the progress of bone formation. Results: The study commenced enrollment in August 2022 and is scheduled to conclude post assessments and analyses by the end of 2023. The results of the study are anticipated to be accessible in late 2024. Conclusions: This clinical study represents the initial investigation in humans to assess the feasibility and efficacy of $\alpha$-CSH in alveolar bone regeneration. We hypothesize that the inclusion of $\alpha$-CSH can greatly expedite the process of bone formation within fresh sockets, resulting in a swift restoration of bone height without the disadvantages associated with harvesting autogenous bone graft. Trial Registration: Indonesia Registry Center INA-D02FAHP; https://tinyurl.com/2jnf6n3s International Registered Report Identifier (IRRID): DERR1-10.2196/49922 ",
doi="10.2196/49922",
url="https://www.researchprotocols.org/2024/1/e49922",
url="http://www.ncbi.nlm.nih.gov/pubmed/39028555"
}


@Article{info:doi/10.2196/49703,
author="Baik, H. Sharon
and Clark, Karen
and Sanchez, Marisol
and Loscalzo, Matthew
and Celis, Ashley
and Razavi, Marianne
and Yang, Dershung
and Dale, William
and Haas, Niina",
title="Usability and Preliminary Efficacy of an Adaptive Supportive Care System for Patients With Cancer: Pilot Randomized Controlled Trial",
journal="JMIR Cancer",
year="2024",
month="Jul",
day="10",
volume="10",
pages="e49703",
keywords="cancer",
keywords="distress screening",
keywords="eHealth",
keywords="supportive care",
keywords="mobile phone",
abstract="Background: Using an iterative user-centered design process, our team developed a patient-centered adaptive supportive care system, PatientCareAnywhere, that provides comprehensive biopsychosocial screening and supportive cancer care to patients across the continuum of care adaptively. The overarching goal of PatientCareAnywhere is to improve health-related quality of life (HRQOL) and self-efficacy of patients with cancer by empowering them with self-management skills and bringing cancer care support directly to them at home. Such support is adaptive to the patient's needs and health status and coordinated across multiple sources in the forms of referrals, education, engagement of community resources, and secure social communication. Objective: This study aims to assess the usability of the new web-based PatientCareAnywhere system and examine the preliminary efficacy of PatientCareAnywhere to improve patient-reported outcomes compared with usual care. Methods: For phase 1, usability testing participants included patients with cancer (n=4) and caregivers (n=7) who evaluated the software prototype and provided qualitative (eg, interviews) and quantitative (eg, System Usability Scale) feedback. For phase 2, participants in the 3-month pilot randomized controlled trial were randomized to receive the PatientCareAnywhere intervention (n=36) or usual care control condition (n=36). HRQOL and cancer-relevant self-efficacy were assessed at baseline (preintervention assessment) and 12 weeks from baseline (postintervention assessment); mean differences between pre- and postintervention scores were compared between the 2 groups. Results: Participants were highly satisfied with the prototype and reported above-average acceptable usability, with a mean System Usability Scale score of 84.09 (SD 10.02). Qualitative data supported the overall usability and perceived usefulness of the intervention, with a few design features (eg, ``help request'' function) added based on participant feedback. With regard to the randomized controlled trial, patients in the intervention group reported significant improvements in HRQOL from pre- to postintervention scores (mean difference 6.08, SD 15.26) compared with the control group (mean difference ?2.95, SD 10.63; P=.01). In contrast, there was no significant between-group difference in self-efficacy (P=.09). Conclusions: Overall, PatientCareAnywhere represents a user-friendly, functional, and acceptable supportive care intervention with preliminary efficacy to improve HRQOL among patients diagnosed with cancer. Future studies are needed to further establish the efficacy of PatientCareAnywhere as well as explore strategies to enhance user engagement and investigate the optimal intensity, frequency, and use of the intervention to improve patient outcomes. Trial Registration: ClinicalTrials.gov NCT02408406; https://clinicaltrials.gov/study/NCT02408406 ",
doi="10.2196/49703",
url="https://cancer.jmir.org/2024/1/e49703"
}


@Article{info:doi/10.2196/50230,
author="M{\"u}llenmeister, Christina
and Stoelting, Andrea
and Schr{\"o}der, Dominik
and Schmachtenberg, Tim
and Ritter, Simon
and El-Sayed, Iman
and Steffens, Sandra
and Klawonn, Frank
and Klawitter, Sandra
and Homann, Stefanie
and Mikuteit, Marie
and Berg, Christoph
and Behrens, Georg
and Hummers, Eva
and Cook, Aisha
and M{\"u}ller, Frank
and Dopfer-Jablonka, Alexandra
and Happle, Christine",
title="Evaluating the Feasibility, Acceptance, and Beneficial Effects of Online Occupational Therapy for Post--COVID-19 Condition: Protocol for a Randomized Controlled Trial (ErgoLoCo Study)",
journal="JMIR Res Protoc",
year="2024",
month="May",
day="13",
volume="13",
pages="e50230",
keywords="SARS-CoV-2",
keywords="COVID-19",
keywords="post COVID-19 condition",
keywords="pandemic",
keywords="occupational therapy",
keywords="cognitive deficits",
keywords="online treatment",
keywords="long Covid",
keywords="RCT",
keywords="randomized controlled trial",
keywords="controlled trials",
keywords="internet based",
keywords="digital health",
keywords="digital intervention",
keywords="video",
keywords="prerecorded",
keywords="feasibility",
keywords="acceptability",
keywords="effectiveness",
keywords="online therapy",
abstract="Background: Post--COVID-19 syndrome (PCS; also known as ``long COVID'') is a relatively novel disease comprising physical, psychological, and cognitive complaints persisting several weeks to months after acute infection with SARS-CoV-2. Approximately 10\% of patients with COVID-19 are affected by long-term symptoms. However, effective treatment strategies are lacking. The ErgoLoCo (Occupational Therapy [Ergotherapie] for Long COVID) study was designed to develop and evaluate a novel occupational therapy (OT) concept of online delivery of therapy for long COVID. Objective: The primary study objective is to assess the feasibility of the online OT intervention in PCS. Secondary aims include the evaluation of online OT concerning cognitive problems, occupational performance, and social participation. Methods: This randomized controlled interventional pilot study involves parallel mixed methods process analyses and a realist evaluation approach. A total of 80 clients with PCS aged at least 16 years will be recruited into two interventional groups. The control cohort (watch and wait) comprises 80 clients with long COVID. Treatment is provided through teletherapy (n=40) or delivery of prerecorded videos (n=40) using the same standardized OT concept twice weekly over 12 weeks. Analyses of quantitative questionnaires and qualitative interviews based on the theoretical framework of acceptability will be performed to assess feasibility. Focus group meetings will be used to assess how acceptable and helpful the intervention was to the participating occupational therapists. Standardized tests will be used to assess the initial efficacy of the intervention on neurocognitive performance; limitations in mobility, self-care, and everyday activities; pain; disabilities; quality of life (QoL); social participation; and anxiety and depression in PCS, and the possible effects of online OT on these complaints. Results: The German Ministry of Education and Research provided funding for this research in March 2022. Data collection took place from October 2022 to August 31, 2023. Data analysis will be completed by the end of April 2024. We anticipate publishing the results in the fall of 2024. Conclusions: Despite the enormous clinical need, effective and scalable treatment options for OT clients who have PCS remain scarce. The ErgoLoCo study will assess whether online-delivered OT is a feasible treatment approach in PCS. Furthermore, this study will assess the effect of the intervention on cognitive symptoms, QoL, and occupational performance and participation in everyday life. Particular emphasis will be placed on the experiences of clients and occupational therapists with digitally delivered OT. This study will pave the way for novel and effective treatment strategies in PCS. Trial Registration: German Clinical Trial Registry DRKS00029990; https://drks.de/search/de/trial/DRKS00029990 International Registered Report Identifier (IRRID): PRR1-10.2196/50230 ",
doi="10.2196/50230",
url="https://www.researchprotocols.org/2024/1/e50230",
url="http://www.ncbi.nlm.nih.gov/pubmed/38739435"
}


@Article{info:doi/10.2196/51849,
author="Morrow, M. Melissa
and Hughes, C. Lynne
and Collins, M. Diane
and Vos-Draper, L. Tamara",
title="Clinical Remote Monitoring of Individuals With Spinal Cord Injury at Risk for Pressure Injury Recurrence Using mHealth: Protocol for a Pilot, Pragmatic, Hybrid Implementation Trial",
journal="JMIR Res Protoc",
year="2024",
month="Apr",
day="10",
volume="13",
pages="e51849",
keywords="wheelchair user",
keywords="seating and mobility",
keywords="weight shift behavior",
keywords="pressure injury",
keywords="mobile phone",
abstract="Background: Pressure injuries are one of the most challenging secondary conditions for individuals with spinal cord injuries and related disorders (SCI/D) owing to inherent, lifelong risk factors that include a lack of sensory and motor function below the level of injury and reliance on a wheelchair for daily mobility, resulting in prolonged periods of sitting. Although many factors contribute to the development of pressure injuries, the pressure between the skin and a surface is always a factor and the development of injury is dependent on the magnitude and duration of the pressure. Clinically, broad recommendations for relieving pressure are used because we know very little about the unique day-to-day life patterns of the individual wheelchair user. Typically, it is after the occurrence of a pressure injury that the therapist will check equipment fit and the effectiveness of pressure offloading and ask about other surfaces they sit on in their home and community. This time-lapsed, largely self-reported data are fraught with recall bias and inaccuracies that the therapist incorporates into a plan of care. Objective: This study's objective is to pilot-test the implementation and clinical effectiveness of a telehealth model of care combined with our mobile health (mHealth) Assisted Weight-Shift device for remote monitoring of factors related to maintaining skin health and wheelchair setup. Our overall hypothesis is that this study will result in an effective implementation plan, and the enhanced connected model of care using remote monitoring of pressure management will result in pilot-level, improved clinical outcomes for adults with spinal cord injury at high risk for pressure injury recurrence. Methods: For all aims, we will use a mixed methods design using an exploratory, sequential approach to include the strengths of both qualitative and quantitative data. For aims 1 and 2, we will iteratively collect qualitative data from therapists, patients with SCI/D, and other stakeholders. For aim 3, we will perform a hybrid effectiveness-implementation randomized controlled trial to pilot-test the intervention. The projected results include an iteratively developed and tested implementation plan that meets moderate to high levels of acceptability, feasibility, and appropriateness. Additionally, the pilot trial results are expected to show positive trends in relevant clinical outcomes related to reduced pressure injury incidence, recurrence, and improved healing when compared with the standard of care. Results: Currently, 6 participants have been recruited for our aim-1 qualitative study. Conclusions: This study will expand upon our previous study to move the Assisted Weight-Shift system into routine clinical care, which was a strong desire of adults with SCI/D for improved individualized care plans to prevent pressure injuries. The results of this study will guide the next steps in a full, hybrid effectiveness-implementation trial with the goal of improving care to prevent pressure injuries. International Registered Report Identifier (IRRID): DERR1-10.2196/51849 ",
doi="10.2196/51849",
url="https://www.researchprotocols.org/2024/1/e51849",
url="http://www.ncbi.nlm.nih.gov/pubmed/38598267"
}


@Article{info:doi/10.2196/55687,
author="Carter, Jocelyn
and Swack, Natalia
and Isselbacher, Eric
and Donelan, Karen
and Thorndike, Anne",
title="Feasibility, Acceptability, and Preliminary Effectiveness of a Combined Digital Platform and Community Health Worker Intervention for Patients With Heart Failure: Protocol for a Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2024",
month="Feb",
day="6",
volume="13",
pages="e55687",
keywords="heart failure",
keywords="digital platform",
keywords="remote monitoring",
keywords="home-based care",
keywords="health worker",
keywords="social needs care",
keywords="community health worker",
abstract="Background: Interventions focused on remote monitoring and social needs care have shown promise in improving clinical outcomes for patients with heart failure (HF). However, patient willingness to use technology as well as concerns about access in underresourced settings have limited digital platform implementation and adoption. There is little research in HF populations examining the effect of a combined digital and social needs care intervention that could enhance patient engagement in digital platform use while closing gaps in care related to social determinants of health. Here, we describe the protocol for a clinical trial of a digitally enabled community health worker intervention designed for patients with HF. Objective: This study aims to describe the protocol for a randomized controlled trial assessing the acceptability, feasibility, and preliminary effectiveness of an intervention that combines remote monitoring with a digital platform and community health worker (CHW) social needs care for patients with HF who are transitioning from hospital to home. Given the elevated morbidity and mortality, identifying comprehensive and patient-centered interventions at the time of hospital care transitions that can improve clinical outcomes, impact cost, and augment the quality of care for this cohort is a priority. Methods: This trial randomized adult inpatient participants (n=50) with a diagnosis of HF receiving care at a single academic health care institution to the 30-day intervention (digital platform+CHW pairing+usual care) or the 30-day control (CHW pairing+usual care) arms. All study participants completed baseline questionnaires and 30-day exit interviews and questionnaires. The primary outcomes will be acceptability, feasibility, and preliminary effectiveness. Results: This clinical trial opened for enrollment in September 2022 and was completed in June 2023. Initial results are expected to be published in the spring of 2024, and analysis is currently underway. Feasibility outcome measures will include the use rates of the biometric sensor (average hours per day), the digital blood pressure monitor (average times per day), the weight scale (average times per day), and the completion of the symptoms questionnaire (average times per day). The acceptability outcome will be measured by the patients' response to the truthfulness of the statement that they would be willing to use the digital platform in the future (response options: very true, somewhat true, or not true). Preliminary effectiveness will be measured by tracking 30-day clinical outcomes (hospital readmissions, emergency room visits, and missed primary care and cardiology appointments). Conclusions: The results of this investigation are expected to contribute to our understanding of the use of digital interventions and the implementation of supportive home-based social needs care to enhance engagement and the potential effectiveness of clinically focused digital platforms. These results may inform the construction of a future multi-institutional trial designed to test the true effectiveness of this intervention in HF. Trial Registration: ClinicalTrials.gov NCT05130008; https://clinicaltrials.gov/study/NCT05130008 International Registered Report Identifier (IRRID): DERR1-10.2196/55687 ",
doi="10.2196/55687",
url="https://www.researchprotocols.org/2024/1/e55687",
url="http://www.ncbi.nlm.nih.gov/pubmed/38216543"
}


@Article{info:doi/10.2196/49705,
author="Fleischman, Alyssa
and Lerner, Carlos
and Kloster, Heidi
and Chung, Paul
and Klitzner, Thomas
and Cushing, Christopher
and Gerber, Danielle
and Katz, Barbara
and Warner, Gemma
and Singh-Verdeflor, Devi Kristina
and Delgado-Martinez, Roxana
and Porras-Javier, Lorena
and Ia, Siem
and Wagner, Teresa
and Ehlenbach, Mary
and Coller, Ryan",
title="Adaptive Intervention to Prevent Respiratory Illness in Cerebral Palsy: Protocol for a Feasibility Pilot Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2024",
month="Jan",
day="8",
volume="13",
pages="e49705",
keywords="just-in-time adaptive intervention",
keywords="respiratory illness",
keywords="cerebral palsy",
keywords="action planning",
keywords="digital health",
abstract="Background: This study will pilot-test an innovative just-in-time adaptive intervention to reduce severe respiratory illness among children with severe cerebral palsy (CP). Our intervention program, Respiratory Exacerbation--Plans for Action and Care Transitions (RE-PACT), delivers timely customized action planning and rapid clinical response when hospitalization risk is elevated. Objective: This study aims to establish RE-PACT's feasibility, acceptability, and fidelity in up to 90 children with severe CP. An additional aim is to preliminarily estimate RE-PACT's effect size. Methods: The study will recruit up to 90 caregivers of children with severe CP aged 0 to 17 years who are cared for by a respiratory specialist or are receiving daily respiratory treatments. Participants will be recruited from pediatric complex care programs at the University of Wisconsin--Madison (UW) and the University of California, Los Angeles (UCLA). Study participants will be randomly assigned to receive usual care through the complex care clinical program at UW or UCLA or the study intervention, RE-PACT. The intervention involves action planning, rapid clinical response to prevent and manage respiratory illness, and weekly SMS text messaging surveillance of caregiver confidence for their child to avoid hospitalization. RE-PACT will be run through 3 successively larger 6-month trial waves, allowing ongoing protocol refinement according to prespecified definitions of success for measures of feasibility, acceptability, and fidelity. The feasibility measures include recruitment and intervention time. The acceptability measures include recruitment and completion rates as well as intervention satisfaction. The fidelity measures include observed versus expected rates of intervention and data collection activities. The primary clinical outcome is a severe respiratory illness, defined as a respiratory diagnosis requiring hospitalization. The secondary clinical outcomes include?hospital days and emergency department visits, systemic steroid courses, systemic antibiotic courses, and death from severe respiratory illness. Results: The recruitment of the first wave began on April 27, 2022. To date, we have enrolled 30 (33\%) out of 90 participants, as projected. The final wave of recruitment will end by October 31, 2023, and the final participant will complete the study by April 30, 2024. We will start analyzing the complete responses by April 30, 2024, and the publication of results is expected at the end of 2024. Conclusions: This pilot intervention, using adaptive just-in-time strategies, represents a novel approach to reducing the incidence of significant respiratory illness for children with severe CP. This protocol may be helpful to other researchers and health care providers caring for patients at high risk for acute severe illness exacerbations. Trial Registration: ClinicalTrials.gov NCT05292365; https://clinicaltrials.gov/study/NCT05292365 International Registered Report Identifier (IRRID): DERR1-10.2196/49705 ",
doi="10.2196/49705",
url="https://www.researchprotocols.org/2024/1/e49705",
url="http://www.ncbi.nlm.nih.gov/pubmed/38190242"
}


@Article{info:doi/10.2196/53094,
author="Coronado-Montoya, Stephanie
and Abdel-Baki, Amal
and C{\^o}t{\'e}, Jos{\'e}
and Crockford, David
and Dubreucq, Simon
and Fischer, Benedikt
and Lachance-Touchette, Pamela
and Lecomte, Tania
and L'Heureux, Sophie
and Ouellet-Plamondon, Clair{\'e}laine
and Roy, Marc-Andr{\'e}
and Tatar, Ovidiu
and Tibbo, Phillip
and Villeneuve, Marie
and Wittevrongel, Anne
and Jutras-Aswad, Didier",
title="Evaluation of a Cannabis Harm Reduction Intervention for People With First-Episode Psychosis: Protocol for a Pilot Multicentric Randomized Trial",
journal="JMIR Res Protoc",
year="2023",
month="Dec",
day="18",
volume="12",
pages="e53094",
keywords="cannabis, psychosis, harm reduction, pilot, mobile health",
keywords="psychological intervention",
keywords="mHealth",
keywords="young adult",
keywords="schizophrenia",
keywords="motivational interviewing",
keywords="intervention",
keywords="RCT",
keywords="randomized",
keywords="controlled trial",
keywords="controlled trials",
keywords="multi-centric",
keywords="young people",
keywords="clinical trials",
keywords="feasibility",
keywords="perspectives",
keywords="perspective",
keywords="evidence-based",
abstract="Background: Cannabis use is highly prevalent in young people with first-episode psychosis (FEP). Most report cannabis use and are often diagnosed with a cannabis use disorder upon admission to specialized services for psychosis. Cannabis use in this population is associated with worse clinical and psychosocial outcomes, rendering it an important clinical target. Despite this, few cannabis-specific interventions have been developed for FEP and empirically evaluated through randomized controlled trials. Most evaluated interventions have targeted cannabis abstinence, with limited efficacy, but none have centered on harm reduction outcomes for people with FEP who use cannabis. Early intervention services (EIS), the standard of care for FEP, have not successfully addressed problematic cannabis use in people with FEP either. Clinical trials are needed to explore the potential of harm reduction strategies, although these should be preceded by robust pilot studies to establish optimal design and approaches. Objective: Recognizing the need for harm reduction strategies for individuals with FEP who use cannabis and based on research on patients' preferences supporting harm reduction interventions, we developed a mobile app--based cannabis harm reduction intervention for this population. This intervention is called Cannabis Harm--reducing Application to Manage Practices Safely (CHAMPS). Here, we describe the protocol for a multicenter, 2-arm, parallel group, randomized pilot trial evaluating the acceptability of CHAMPS for people with FEP who use cannabis and the feasibility of conducting a full-scale trial in this population using CHAMPS. The impact on key clinical outcomes will also be explored. Methods: This pilot trial aims to recruit 100 young people with FEP using cannabis from 6 Canadian EIS clinics. Participants will be randomized in a 1:1 ratio to CHAMPS+EIS or EIS-only. CHAMPS acceptability will be assessed using completion rates for the intervention arm. Trial feasibility will be assessed using a retention rate for randomized participants. Secondary outcomes will explore tendencies of change in the use of protective behavioral strategies and in motivation to change strategies. Exploratory outcomes include cannabis use--related problems, other substance use, the severity of dependence, psychotic symptoms, and health care service use. Results: Recruitment began in December 2021. Data collection and analysis are expected to be completed in early 2024. Study results describing CHAMPS acceptability and trial feasibility will then be submitted for publication in a peer-reviewed journal. Conclusions: CHAMPS uniquely combines evidence-based approaches, patient perspectives, and mobile health technology to support harm reduction in people with FEP who use cannabis. Attaining adequate acceptability and feasibility through this trial may justify further exploration of harm reduction tools, particularly within the context of conducting a larger-scale randomized controlled trial. This pilot trial has the potential to advance knowledge for researchers and clinicians regarding a feasible and user-acceptable research design in the cannabis and early psychosis fields. Trial Registration: ClinicalTrials.gov NCT04968275, https://clinicaltrials.gov/ct2/show/NCT04968275 International Registered Report Identifier (IRRID): DERR1-10.2196/53094 ",
doi="10.2196/53094",
url="https://www.researchprotocols.org/2023/1/e53094",
url="http://www.ncbi.nlm.nih.gov/pubmed/38109196"
}


@Article{info:doi/10.2196/49196,
author="Pastor-Idoate, Salvador
and Mateos-Olivares, Milagros
and Sobas, Mar{\'i}a Eva
and Marcos, Miguel
and Toribio, Alfredo
and Pastor, Carlos Jos{\'e}
and Usategui Mart{\'i}n, Ricardo",
title="Short-Wavelength Light--Blocking Filters and Oral Melatonin Administration in Patients With Retinitis Pigmentosa: Protocol for a Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2023",
month="Nov",
day="16",
volume="12",
pages="e49196",
keywords="retinitis pigmentosa",
keywords="oral melatonin",
keywords="short-wavelength light",
keywords="intrinsically photosensitive retinal ganglion cells",
keywords="ipGC",
keywords="retinal dystrophy",
keywords="quality of life",
keywords="rare eye disease",
keywords="eye disease",
keywords="burden",
keywords="health care system",
keywords="intervention",
keywords="treatment",
keywords="vision loss",
keywords="psychological stress",
keywords="sleep disorder",
keywords="eye",
keywords="retina",
keywords="cornea",
keywords="lens",
keywords="glaucoma",
keywords="cataract",
abstract="Background: The medical community is beginning to recognize that retinitis pigmentosa (RP), due to its disabling progression, eventually leads to a reduction in the patient{\textasciiacute}s quality of life, a direct economic impact, and an increase in the burden on the health care system. There is no curative treatment for the origin of the disease, and most of the current interventions fail in reducing the associated negative psychological states, such as anxiety and depression, which lead to increased variability of vision and pose a continuous threat to the patient's independence. Objective: The aim of this study is to assess the effect of oral melatonin (OM) administration alone and combined with short-wavelength light (SWL)--blocking filters on patients with RP and test their effectiveness in improving the level of stress and sleep problems in many of these patients. Methods: We have developed a low-cost therapy protocol for patients with RP with sleep disorders and negative psychological stress. Patients will be randomized to receive a combined intervention with SWL-blocking filters and OM, SWL-blocking filters alone, or OM alone. There will also be a nonintervention arm as a control group. This study will be conducted across 2 retinal units in patients with RP with sleep disorders and high perceived stress and anxiety score reports. Patients will be assessed in the preintervention period, weekly during the 4 weeks of intervention, and then at 6 months postintervention. The primary outcomes are the differences in changes from baseline to postintervention in hormone release ($\alpha$-amylase, cortisol, and melatonin) and sleep quality, as measured with the visual analog scale. Secondary outcome measures include clinical macular changes, as measured with optical coherence tomography and optical coherence tomography angiography; retinal function, as measured using the visual field and best-corrected visual acuity; sleep data collected from personal wearables; and several patient-reported variables, such as self-recorded sleep diaries, quality of life, perceived stress, and functional status. Results: This project is still a study protocol and has not yet started. Bibliographic research for information for its justification began in 2020, and this working group is currently seeking start-up funding. As soon as we have the necessary means, we will proceed with the registration and organization prior to the preliminary phase. Conclusions: In this feasibility randomized clinical controlled trial, we will compare the effects of SWL blocking alone, administration of OM alone, and a combined intervention with both in patients with RP. We present this study so that it may be replicated and incorporated into future studies at other institutions, as well as applied to additional inherited retinal dystrophies. The goal of presenting this protocol is to aid recent efforts in reducing the impact of sleeping disorders and other psychological disorders on the quality of life in patients with RP and recovering their self-autonomy. In addition, the results of this study will represent a significant step toward developing a novel low-cost therapy for patients with RP and validating a novel therapeutic target. International Registered Report Identifier (IRRID): PRR1-10.2196/49196 ",
doi="10.2196/49196",
url="https://www.researchprotocols.org/2023/1/e49196",
url="http://www.ncbi.nlm.nih.gov/pubmed/37971796"
}


@Article{info:doi/10.2196/49377,
author="Seinsche, Julia
and de Bruin, D. Eling
and Saibene, Enrico
and Rizzo, Francesco
and Carpinella, Ilaria
and Ferrarin, Maurizio
and Ifanger, Sarina
and Moza, Sotiria
and Giannouli, Eleftheria",
title="Feasibility and Effectiveness of a Personalized Home-Based Motor-Cognitive Training Program in Community-Dwelling Older Adults: Protocol for a Pragmatic Pilot Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2023",
month="Nov",
day="9",
volume="12",
pages="e49377",
keywords="telerehabilitation",
keywords="home-based",
keywords="eHealth",
keywords="exergaming",
keywords="older adults",
keywords="motor-cognitive training",
keywords="feasibility",
keywords="pragmatic trial",
abstract="Background: Exergame-based motor-cognitive training in older adults has been associated with improvements in physical, cognitive, and psychological functioning. The novel Cocare system (Dividat GmbH), developed through a user-centered design process, allows motor-cognitive training in a telerehabilitation setting. It includes (1) a stationary stepping platform for supervised exergame training (Dividat Senso; Dividat GmbH), (2) a home-based version (Dividat Senso Flex, which is a rollable pressure-sensitive mat; Dividat GmbH), (3) an assessment system (including motor-cognitive tests), and (4) a rehabilitation cockpit for remote training supervision and management. Objective: The aim of this study is to test the feasibility and effectiveness of this novel training system. Methods: A total of 180 older adults from Switzerland, Italy, and Cyprus aged ?60 years with a prescription for rehabilitation are randomly allocated to an intervention group or a control group. Both groups continue with their usual care, whereas participants in the intervention group additionally perform a 2-week supervised exergame training program at rehabilitation centers, followed by a 10-week home training program under remote supervision. The assessment system is used to indicate the start level of each participant, and, in both intervention periods, standardized progression rules are applied. The measures of feasibility include adherence, attrition, exergame enjoyment, willingness to perform such a training program, and the number and types of help requests. Effectiveness is assessed in terms of cognitive and physical functioning, balance confidence, and quality of life. Results: Data collection started in February 2023 and is ongoing. Final measurements are expected to be performed in January 2024. Conclusions: Owing to the user-centered design approach, the Cocare system is expected to be user-friendly and offers several novel features to cover the whole continuum of care. This pragmatic trial will provide valuable information regarding final necessary adaptations and subsequent implementation efforts. Trial Registration: ClinicalTrials.gov NCT05751551; https://www.clinicaltrials.gov/study/NCT05751551 International Registered Report Identifier (IRRID): DERR1-10.2196/49377 ",
doi="10.2196/49377",
url="https://www.researchprotocols.org/2023/1/e49377",
url="http://www.ncbi.nlm.nih.gov/pubmed/37943591"
}


@Article{info:doi/10.2196/48758,
author="Thomson, Louise
and Hassard, Juliet
and Frost, Alexandra
and Bartle, Craig
and Yarker, Joanna
and Munir, Fehmidah
and Kneller, Richard
and Marwaha, Steven
and Daly, Guy
and Russell, Sean
and Meyer, Caroline
and Vaughan, Benjamin
and Newman, Kristina
and Blake, Holly",
title="Digital Training Program for Line Managers (Managing Minds at Work): Protocol for a Feasibility Pilot Cluster Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2023",
month="Oct",
day="24",
volume="12",
pages="e48758",
keywords="acceptability",
keywords="anxiety",
keywords="burnout",
keywords="cluster randomised control trial",
keywords="depression",
keywords="digital training",
keywords="feasibility",
keywords="intervention",
keywords="managers",
keywords="mental health",
keywords="stress",
keywords="usability",
keywords="work",
keywords="workplace",
abstract="Background: Mental health problems affect 1 in 6 workers annually and are one of the leading causes of sickness absence, with stress, anxiety, and depression being responsible for half of all working days lost in the United Kingdom. Primary interventions with a preventative focus are widely acknowledged as the priority for workplace mental health interventions. Line managers hold a primary role in preventing poor mental health within the workplace and, therefore, need to be equipped with the skills and knowledge to effectively carry out this role. However, most previous intervention studies have directly focused on increasing line managers' understanding and awareness of mental health rather than giving them the skills and competencies to take a proactive preventative approach in how they manage and design work. The Managing Minds at Work (MMW) digital training intervention was collaboratively designed to address this gap. The intervention aims to increase line managers' knowledge and confidence in preventing work-related stress and promoting mental health at work. It consists of 5 modules providing evidence-based interactive content on looking after your mental health, designing and managing work to promote mental well-being, management competencies that prevent work-related stress, developing a psychologically safe workplace, and having conversations about mental health at work. Objective: The primary aim of this study is to pilot and feasibility test MMW, a digital training intervention for line managers. Methods: We use a cluster randomized controlled trial design consisting of 2 arms, the intervention arm and a 3-month waitlist control, in this multicenter feasibility pilot study. Line managers in the intervention arm will complete a baseline questionnaire at screening, immediately post intervention (approximately 6 weeks after baseline), and at 3- and 6-month follow-ups. Line managers in the control arm will complete an initial baseline questionnaire, repeated after 3 months on the waitlist. They will then be granted access to the MMW intervention, following which they will complete the questionnaire post intervention. The direct reports of the line managers in both arms of the trial will also be invited to take part by completing questionnaires at baseline and follow-up. As a feasibility pilot study, a formal sample size is not required. A minimum of 8 clusters (randomized into 2 groups of 4) will be sought to inform a future trial from work organizations of different types and sectors. Results: Recruitment for the study closed in January 2022. Overall, 24 organizations and 224 line managers have been recruited. Data analysis was finished in August 2023. Conclusions: The results from this feasibility study will provide insight into the usability and acceptability of the MMW intervention and its potential for improving line manager outcomes and those of their direct reports. These results will inform the development of subsequent trials. Trial Registration: ClinicalTrials.gov NCT05154019; https://clinicaltrials.gov/study/NCT05154019 International Registered Report Identifier (IRRID): DERR1-10.2196/48758 ",
doi="10.2196/48758",
url="https://www.researchprotocols.org/2023/1/e48758",
url="http://www.ncbi.nlm.nih.gov/pubmed/37874612"
}


@Article{info:doi/10.2196/47151,
author="Skeen, J. Simone
and Tokarz, Stephanie
and Gasik, E. Rayna
and Solano, McGettigan Chelsea
and Smith, A. Ethan
and Sagoe, Binaifer Momi
and Hudson, V. Lauryn
and Steele, Kara
and Theall, P. Katherine
and Clum, A. Gretchen",
title="A Trauma-Informed, Geospatially Aware, Just-in-Time Adaptive mHealth Intervention to Support Effective Coping Skills Among People Living With HIV in New Orleans: Development and Protocol for a Pilot Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2023",
month="Oct",
day="24",
volume="12",
pages="e47151",
keywords="mobile health",
keywords="mHealth",
keywords="HIV",
keywords="traumatic stress",
keywords="posttraumatic growth",
keywords="coping",
keywords="geospatial",
keywords="just-in-time adaptive intervention",
keywords="JITAI",
keywords="just-in-time",
keywords="posttraumatic",
keywords="medication adherence",
keywords="mental well-being",
keywords="viral suppression",
keywords="development",
keywords="design",
keywords="acceptability",
keywords="feasibility",
keywords="mobile phone",
abstract="Background: In 2020, Greater New Orleans, Louisiana, was home to 7048 people living with HIV---1083 per 100,000 residents, 2.85 times the US national rate. With Louisiana routinely ranked last in indexes of health equity, violent crime rates in Orleans Parish quintupling national averages, and in-care New Orleans people living with HIV surviving twice the US average of adverse childhood experiences, accessible, trauma-focused, evidence-based interventions (EBIs) for violence-affected people living with HIV are urgently needed. Objective: To meet this need, we adapted Living in the Face of Trauma, a well-established EBI tailored for people living with HIV, into NOLA GEM, a just-in-time adaptive mobile health (mHealth) intervention. This study aimed to culturally tailor and refine the NOLA GEM app and assess its acceptability; feasibility; and preliminary efficacy on care engagement, medication adherence, viral suppression, and mental well-being among in-care people living with HIV in Greater New Orleans. Methods: The development of NOLA GEM entailed identifying real-time tailoring variables via a geographic ecological momentary assessment (GEMA) study (n=49; aim 1) and place-based and user-centered tailoring, responsive to the unique cultural contexts of HIV survivorship in New Orleans, via formative interviews (n=12; aim 2). The iOS- and Android-enabled NOLA GEM app leverages twice-daily GEMA prompts to offer just-in-time, in-app recommendations for effective coping skills practice and app-delivered Living in the Face of Trauma session content. For aim 3, the pilot trial will enroll an analytic sample of 60 New Orleans people living with HIV individually randomized to parallel NOLA GEM (intervention) or GEMA-alone (control) arms at a 1:1 allocation for a 21-day period. Acceptability and feasibility will be assessed via enrollment, attrition, active daily use through paradata metrics, and prevalidated usability measures. At the postassessment time point, primary end points will be assessed via a range of well-validated, domain-specific scales. Care engagement and viral suppression will be assessed via past missed appointments and self-reported viral load at 30 and 90 days, respectively, and through well-demonstrated adherence self-efficacy measures. Results: Aims 1 and 2 have been achieved, NOLA GEM is in Beta, and all aim-3 methods have been reviewed and approved by the institutional review board of Tulane University. Recruitment was launched in July 2023, with a target date for follow-up assessment completion in December 2023. Conclusions: By leveraging user-centered development and embracing principles that elevate the lived expertise of New Orleans people living with HIV, mHealth-adapted EBIs can reflect community wisdom on posttraumatic resilience. Sustainable adoption of the NOLA GEM app and a promising early efficacy profile will support the feasibility of a future fully powered clinical trial and potential translation to new underserved settings in service of holistic survivorship and well-being of people living with HIV. Trial Registration: ClinicalTrials.gov NCT05784714; https://clinicaltrials.gov/ct2/show/NCT05784714 International Registered Report Identifier (IRRID): PRR1-10.2196/47151 ",
doi="10.2196/47151",
url="https://www.researchprotocols.org/2023/1/e47151",
url="http://www.ncbi.nlm.nih.gov/pubmed/37874637"
}


@Article{info:doi/10.2196/48459,
author="Davis-Ewart, Leah
and Grov, Christian
and Verhagen, Rachel
and Manuel, Jennifer
and Viamonte, Michael
and Dilworth, Samantha
and O'Dell, Nicole
and Valentin, Omar
and Carr, Sidney
and Cherenack, Emily
and Henderson, Chelsea
and Doblecki-Lewis, Susanne
and Nahum-Shani, Inbal
and Carrico, W. Adam",
title="Motivational Enhancement Interventions to Increase Pre-Exposure Prophylaxis Use in Sexual Minority Men Who Use Stimulants: Protocol for a Pilot Sequential Multiple Assignment Randomized Trial",
journal="JMIR Res Protoc",
year="2023",
month="Oct",
day="13",
volume="12",
pages="e48459",
keywords="cocaine",
keywords="contingency management",
keywords="methamphetamine",
keywords="motivational interviewing",
keywords="pre-exposure prophylaxis",
keywords="intervention",
keywords="men",
keywords="stimulant",
keywords="condom",
keywords="HIV testing",
keywords="prevention",
keywords="HIV",
keywords="effectiveness",
keywords="telehealth",
keywords="motivation",
abstract="Background: Although pre-exposure prophylaxis (PrEP) could substantially mitigate HIV risk, sexual minority men who use stimulants commonly experience difficulties with engaging in PrEP clinical services. Motivational interviewing (MI) and contingency management (CM) reduce substance use and condomless anal sex (CAS) in this population, but these motivational enhancement interventions require modifications to promote engagement along the PrEP care continuum. Objective: PrEP Readiness Interventions for Supporting Motivation (PRISM) is a pilot sequential multiple assignment randomized trial testing the feasibility, acceptability, and preliminary effectiveness of distinct combinations of telehealth MI and CM in 70 cisgender sexual minority men who use stimulants that are not currently taking PrEP. Methods: A national sample was recruited via social networking applications to complete a baseline assessment and mail-in HIV testing. Those with nonreactive HIV results were randomized to receive either (1) a 2-session MI intervention focusing on PrEP use (session 1) and concomitant stimulant use or CAS (session 2) or (2) a CM intervention with financial incentives for documented evidence of PrEP clinical evaluation by a medical provider (US \$50) and filling a PrEP prescription (US \$50). At the 3-month follow-up assessment, participants who reported they had not filled a prescription for PrEP were randomized a second time to either (1) switch to a second-stage intervention (ie, MI+CM or CM+MI) or (2) continue with assessments only. Outcomes for both responders and nonresponders were reassessed at a 6-month follow-up. The primary outcome is documented evidence of filling a PrEP prescription over 6 months. Self-reported secondary outcomes include PrEP clinical evaluation by a medical provider, stimulant use, and CAS. Qualitative exit interviews were conducted with a subgroup of responders and nonresponders to characterize their experiences with the MI and CM interventions. Results: Implementation of PRISM underscores challenges in reaching sexual minority men who use stimulants to optimize HIV prevention efforts. Approximately 1 in 10 (104/1060) eligible participants have enrolled. Of the 104 who enrolled, 87 (84\%) completed mail-in HIV testing. We delivered 5 preliminary HIV-positive results, including posttest counseling with referrals to confirmatory testing. Conclusions: Lessons learned from PRISM underscore the central importance of a flexible, participant-centered approach to support the engagement of sexual minority men who use stimulants. Leveraging telehealth platforms to deliver motivational enhancement interventions also expanded their reach and potential public health impact with this high-priority population. Further research is needed to determine the effectiveness of telehealth MI and CM for supporting PrEP use in sexual minority men who use stimulants. Trial Registration: ClinicalTrials.gov NCT04205487; https://clinicaltrials.gov/study/NCT04205487 International Registered Report Identifier (IRRID): DERR1-10.2196/48459 ",
doi="10.2196/48459",
url="https://www.researchprotocols.org/2023/1/e48459",
url="http://www.ncbi.nlm.nih.gov/pubmed/37831485"
}


@Article{info:doi/10.2196/48585,
author="Nguyen, Anna
and Nagykaldi, Zsolt
and Bui, Thanh
and Chen, Sixia
and Businelle, Michael
and Eschiti, Valerie
and Dwyer, Kathleen",
title="mHealth Intervention for Vietnamese Living With Diabetes: Protocol for a Stepped Wedge Pilot Study",
journal="JMIR Res Protoc",
year="2023",
month="Sep",
day="28",
volume="12",
pages="e48585",
keywords="Vietnamese",
keywords="type 2 diabetes",
keywords="diabetes self-management",
keywords="mobile health technology",
keywords="intervention study",
keywords="stepped wedge design",
keywords="mobile health",
keywords="intervention",
keywords="mobile app",
keywords="digital health",
keywords="diabetes",
keywords="self-management",
keywords="awareness",
keywords="mhealth",
keywords="implementation",
abstract="Background: Evidence indicates participation in a diabetes self-management education and support program improves self-care behaviors and hemoglobin A1c. Language and cultural differences may be barriers to program participation resulting in ineffective self-management, but these factors can be addressed with appropriate interventions. Given the high health care costs associated with diabetes complications, we developed a multicomponent, culturally tailored Self-Management Mobile Health Intervention for US Vietnamese With Diabetes (SMart-D). Objective: This study aims to evaluate the SMart-D intervention's feasibility, acceptability, and effectiveness with intentions to scale up the intervention in the future. This mixed methods study incorporates the Reach, Effectiveness, Adoption, Implementation, Maintenance framework to evaluate the intervention. Methods: This stepped wedge randomized controlled pilot study will be conducted over 2 years in collaboration with primary care clinics. Eligible participants are patients with type 2 diabetes who are receiving health care from participating clinics. Clinics will be randomly assigned to an implementation date and will begin with patients enrolling in the control period while receiving standard care, then cross over to the intervention period where patients receive standard care plus the SMart-D intervention for over 12 weeks. Focus groups or interviews will be conducted with clinicians and patients after study completion. Qualitative data will be analyzed using NVivo. Outcomes on self-care behavior changes will be measured with the Summary of Diabetes Self-Care Activities scale and clinical changes will be measured using laboratory tests. A generalized linear mixed-effect model will be used to compute time effect, clustering effect, and the interaction of the control and intervention periods using SAS (version 9.4; SAS Institute). Results: We hypothesize that (1) at least 50\% (n=5) of eligible clinics and 50\% (n=40) of eligible patients who are invited will participate, and at least 70\% (n=56) of patients will complete the program, and (2) patients who receive the intervention will have improved self-care behaviors and clinical test results with at least 75\% (n=60) of the patients maintaining improved outcomes at follow-up visits compared with baseline, and participants will verbalize that the intervention is feasible and acceptable. As of August 2023, we enrolled 10 clinics and 60 patients. Baseline data results will be available by the end of 2023 and outcome data will be published in 2025. Conclusions: This is the first Vietnamese diabetes self-management education and support intervention that leverages mobile health technology to address the barriers of language and culture differences through collaboration with primary care clinics. This study will provide a better understanding of the implementation process, demonstrate the potential effectiveness of the intervention, accelerate the pace of moving evidence-based interventions to practice among the US Vietnamese population, and potentially provide a replicable implementation model that can be culturally adapted to other non-English speaking ethnic minorities. International Registered Report Identifier (IRRID): DERR1-10.2196/48585 ",
doi="10.2196/48585",
url="https://www.researchprotocols.org/2023/1/e48585",
url="http://www.ncbi.nlm.nih.gov/pubmed/37768716"
}


@Article{info:doi/10.2196/43376,
author="Ader, Leonie
and Schick, Anita
and L{\"o}ffler, Martin
and L{\"o}ffler, Annette
and Beiner, Eva
and Eich, Wolfgang
and Vock, Stephanie
and Sirazitdinov, Andrei
and Malone, Christopher
and Hesser, J{\"u}rgen
and Hopp, Michael
and Ruckes, Christian
and Flor, Herta
and Tesarz, Jonas
and Reininghaus, Ulrich",
title="Refocusing of Attention on Positive Events Using Monitoring-Based Feedback and Microinterventions for Patients With Chronic Musculoskeletal Pain in the PerPAIN Randomized Controlled Trial: Protocol for a Microrandomized Trial",
journal="JMIR Res Protoc",
year="2023",
month="Sep",
day="20",
volume="12",
pages="e43376",
keywords="experience sampling method",
keywords="ESM",
keywords="ecological momentary intervention",
keywords="EMI",
keywords="microrandomized trial",
keywords="mobile health",
keywords="mHealth",
keywords="positive intervention",
keywords="complex intervention",
keywords="mobile phone",
abstract="Background: Chronic musculoskeletal pain (CMSP) affects between 13\% and 47\% of the population, with a global growth rate of 20.3\% within the last 15 years, suggesting that there is a high need for effective treatments. Pain diaries have long been a common tool in nonpharmacological pain treatment for monitoring and providing feedback on patients' symptoms in daily life. More recently, positive refocusing techniques have come to be used, promoting pain-free episodes and positive outcomes rather than focusing on managing the pain. Objective: This study aims to evaluate the feasibility (ie, acceptability, intervention adherence, and fidelity) and initial signals of efficacy of the PerPAIN app, an ecological momentary intervention for patients with CMSP. The app comprises digitalized monitoring using the experience sampling method (ESM) and feedback. In addition, the patients receive 3 microinterventions targeted at refocusing of attention on positive events. Methods: In a microrandomized trial, we will recruit 35 patients with CMSP who will be offered the app for 12 weeks. Participants will be prompted to fill out 4 ESM monitoring questionnaires a day assessing information on their current context and the proximal outcome variables: absence of pain, positive mood, and subjective activity. Participants will be randomized daily and weekly to receive no feedback, verbal feedback, or visual feedback on proximal outcomes assessed by the ESM. In addition, the app will encourage participants to complete 3 microinterventions based on positive psychology and cognitive behavioral therapy techniques. These microinterventions are prompts to report joyful moments and everyday successes or to plan pleasant activities. After familiarizing themselves with each microintervention individually, participants will be randomized daily to receive 1 of the 3 exercises or none. We will assess whether the 2 feedback types and the 3 microinterventions increase proximal outcomes at the following time point. The microrandomized trial is part of the PerPAIN randomized controlled trial (German Clinical Trials Register DRKS00022792) investigating a personalized treatment approach to enhance treatment outcomes in CMSP. Results: Approval was granted by the Ethics Committee II of the University of Heidelberg on August 4, 2020. Recruitment for the microrandomized trial began in May 2021 and is ongoing at the time of submission. By October 10, 2022, a total of 24 participants had been enrolled in the microrandomized trial. Conclusions: This trial will provide evidence on the feasibility of the PerPAIN app and the initial signals of efficacy of the different intervention components. In the next step, the intervention would need to be further refined and investigated in a definitive trial. This ecological momentary intervention presents a potential method for offering low-level accessible treatment to a wide range of people, which could have substantial implications for public health by reducing disease burden of chronic pain in the population. International Registered Report Identifier (IRRID): DERR1-10.2196/43376 ",
doi="10.2196/43376",
url="https://www.researchprotocols.org/2023/1/e43376",
url="http://www.ncbi.nlm.nih.gov/pubmed/37728983"
}


@Article{info:doi/10.2196/47137,
author="Mulawa, I. Marta
and Hoare, Jacqueline
and Knippler, T. Elizabeth
and Mtukushe, Bulelwa
and Matiwane, Mluleki
and Muessig, E. Kathryn
and Al-Mujtaba, Maryam
and Wilkinson, Harper T.
and Platt, Alyssa
and Egger, R. Joseph
and Hightow-Weidman, B. Lisa",
title="MASI, a Smartphone App to Improve Treatment Adherence Among South African Adolescents and Young Adults With HIV: Protocol for a Pilot Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2023",
month="Sep",
day="19",
volume="12",
pages="e47137",
keywords="HIV",
keywords="adherence",
keywords="mHealth",
keywords="digital health",
keywords="smartphone",
keywords="adolescents and young adults",
keywords="youths",
keywords="South Africa",
keywords="social support",
keywords="randomized",
keywords="controlled trial",
keywords="pilot",
keywords="antiretroviral therapy",
keywords="sexually transmitted",
keywords="app",
keywords="apps",
keywords="mobile phone",
abstract="Background: Adolescents and young adults with HIV repeatedly demonstrate low rates of antiretroviral therapy (ART) adherence as well as low rates of viral suppression. Digital health interventions are a promising way to engage adolescents and young adults with HIV to support ART adherence. However, few digital health interventions have been developed and tested with adolescents and young adults in countries like South Africa, where the HIV burden among adolescents and young adults is greatest. Masakhane Siphucule Impilo Yethu (MASI; Xhosa for ``Let's empower each other and improve our health'') is a comprehensive ART adherence-supporting app for South African adolescents and young adults with HIV. It was culturally adapted using the HealthMpowerment platform. Objective: The aim of this paper is to describe the protocol for a pilot randomized controlled trial examining the feasibility, acceptability, and preliminary efficacy of MASI on self-reported ART adherence and social support. Methods: We will enroll 50 adolescents and young adults with HIV ages 15-21 years. Participants will be recruited from public ART clinics linked to a large government-funded teaching hospital in Cape Town, South Africa. Participants will be randomized 1:1 into either the intervention arm receiving a full version of MASI or the control arm receiving an information-only version of the app (n=25 per arm). Participants will be asked to engage with MASI daily for 6 months. All participants will complete baseline and follow-up assessments at 3 and 6 months. Results: Study screening began in May 2022 and the first participant was enrolled on June 21, 2022. As of June 12, 2023, 81 participants have completed screeners, and 36 eligible participants have been enrolled in the pilot randomized controlled trial. Recruitment is anticipated to last through August 31, 2023, with study activities anticipated through February 29, 2024. Conclusions: There is an urgent need for innovative interventions to improve ART adherence among adolescents and young adults in settings like South Africa. If found to be feasible and acceptable, MASI could be implemented with adolescents and young adults with HIV in other parts of the country. Trial Registration: ClinicalTrials.gov NCT04661878; https://clinicaltrials.gov/ct2/show/study/NCT04661878 International Registered Report Identifier (IRRID): DERR1-10.2196/47137 ",
doi="10.2196/47137",
url="https://www.researchprotocols.org/2023/1/e47137",
url="http://www.ncbi.nlm.nih.gov/pubmed/37725409"
}


@Article{info:doi/10.2196/43654,
author="Sewpaul, Ronel
and Resnicow, Ken
and Crutzen, Rik
and Dukhi, Natisha
and Ellahebokus, Afzal
and Reddy, Priscilla",
title="A Tailored mHealth Intervention for Improving Antenatal Care Seeking and Health Behavioral Determinants During Pregnancy Among Adolescent Girls and Young Women in South Africa: Development and Protocol for a Pilot Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2023",
month="Sep",
day="13",
volume="12",
pages="e43654",
keywords="antenatal care",
keywords="adolescent girls and young women",
keywords="AGYW",
keywords="adolescent pregnancy",
keywords="mobile health",
keywords="mHealth",
keywords="tailoring",
keywords="motivational interviewing",
keywords="South Africa",
keywords="mobile phone",
abstract="Background: South Africa, a middle-income country, has an adolescent fertility rate far higher than that of high-income countries. Adolescent girls and young women have an increased risk of pregnancy-related complications and lower antenatal appointment attendance rates than older adult pregnant women. Mobile health (mHealth) interventions to improve health behaviors among pregnant adolescent girls and young women in low- and middle-income countries are scarce. Objective: This paper describes the development and components of an mHealth intervention to improve antenatal appointment attendance and health behavioral determinants among pregnant adolescent girls and young women in South Africa and details the protocol for a pilot randomized controlled trial that evaluated the intervention's efficacy and user acceptability. Methods: The intervention, Teen MomConnect, sent tailored motivational behavior change and behavioral reinforcement SMS text messages to participants about antenatal appointment keeping and pregnancy behaviors. The delivery methodology of the intervention was adapted from MomConnect, an mHealth education program for pregnant women in South Africa that has nationwide coverage. In addition, participants received a face-to-face motivational interviewing session delivered by a trained research assistant. Pregnant adolescent girls and young women aged 13 to 20 years were recruited from health facilities and community networks. Participants were randomized into the control group that received the standard MomConnect health SMS text messages or the experimental group that received the Teen MomConnect intervention. Participants completed a baseline questionnaire upon enrollment in the study and a follow-up questionnaire after the end of their pregnancy. The questionnaires assessed demographic characteristics, pregnancy behaviors, and the psychosocial determinants of antenatal appointment attendance (knowledge, attitudes, social support, risk perceptions, self-efficacy, intention, and action planning). Feasibility was assessed using descriptive analyses of acceptability, study implementation processes, and perceived satisfaction with the intervention. The number of appointments attended was obtained from the participants' clinic records. Appointment attendance was compared between the control and experimental groups, as were awareness of HIV status and the psychosocial determinants of antenatal appointment attendance. Results: Participant recruitment was conducted from May 2018 to December 2018, and the questionnaire-based data collection was completed by December 2019. Overall, 412 participants were enrolled. Conclusions: This paper describes the Teen MomConnect intervention to improve antenatal appointment attendance and pregnancy health behaviors among adolescent girls and young women. The results on the intervention's preliminary efficacy and user acceptability will inform policy makers and health program officers on how tailored, age-appropriate, and motivational health behavior messages can be delivered via mobile phone to pregnant adolescent girls and young women. Trial Registration: Pan African Clinical Trial Registry (PACTR) PACTR201912734889796; https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=9565 International Registered Report Identifier (IRRID): DERR1-10.2196/43654 ",
doi="10.2196/43654",
url="https://www.researchprotocols.org/2023/1/e43654",
url="http://www.ncbi.nlm.nih.gov/pubmed/37703092"
}


@Article{info:doi/10.2196/46560,
author="Mishra, R. Sonali
and Dempsey, Walter
and Klasnja, Predrag",
title="A Text Messaging Intervention for Priming the Affective Rewards of Exercise in Adults: Protocol for a Microrandomized Trial",
journal="JMIR Res Protoc",
year="2023",
month="Sep",
day="1",
volume="12",
pages="e46560",
keywords="mobile health",
keywords="mHealth interventions",
keywords="physical activity",
keywords="affective attitudes",
keywords="mobile phone",
abstract="Background: Physical activity is a critical target for health interventions, but effective interventions remain elusive. A growing body of work suggests that interventions targeting affective attitudes toward physical activity may be more effective for sustaining activity long term than those that rely on cognitive constructs alone, such as goal setting and self-monitoring. Anticipated affective response in particular is a promising target for intervention. Objective: We will evaluate the efficacy of an SMS text messaging intervention that manipulates anticipated affective response to exercise to promote physical activity. We hypothesize that reminding users of a positive postexercise affective state before their planned exercise sessions will increase their calories burned during this exercise session. We will deploy 2 forms of affective SMS text messages to explore the design space: low-reflection messages written by participants for themselves and high-reflection prompts that require users to reflect and respond. We will also explore the effect of the intervention on affective attitudes toward exercise. Methods: A total of 120 individuals will be enrolled in a 9-week microrandomized trial testing affective messages that remind users about feeling good after exercise (40\% probability), control reminders (30\% probability), or no message (30\% probability). Two types of affective SMS text messages will be deployed: one requiring a response and the other in a read-only format. Participants will write the read-only messages themselves to ensure that the messages accurately reflect the participants' anticipated postexercise affective state. Affective attitudes toward exercise and intrinsic motivation for exercise will be measured at the beginning and end of the study. The weighted and centered least squares method will be used to analyze the effect of delivering the intervention versus not on calories burned over 4 hours around the time of the planned activity, measured by the Apple Watch. Secondary analyses will include the effect of the intervention on step count and active minutes, as well as an investigation of the effects of the intervention on affective attitudes toward exercise and intrinsic motivation for exercise. Participants will be interviewed to gain qualitative insights into intervention impact and acceptability. Results: Enrollment began in May 2023, with 57 participants enrolled at the end of July 2023. We anticipate enrolling 120 participants. Conclusions: This study will provide early evidence about the effect of a repeated manipulation of anticipated affective response to exercise. The use of 2 different types of messages will yield insight into optimal design strategies for improving affective attitudes toward exercise. Trial Registration: ClinicalTrials.gov NCT05582369; https://classic.clinicaltrials.gov/ct2/show/NCT05582369 International Registered Report Identifier (IRRID): PRR1-10.2196/46560 ",
doi="10.2196/46560",
url="https://www.researchprotocols.org/2023/1/e46560",
url="http://www.ncbi.nlm.nih.gov/pubmed/37656493"
}


@Article{info:doi/10.2196/40262,
author="Powell, Georgia
and Gagnon, Marianne
and Komarova, Svetlana
and Rauch, Frank
and Veilleux, Louis-Nicolas",
title="Delivering a Home-Based Exercise Program to Youth With Osteogenesis Imperfecta: Protocol for a Comparative-Approach Study",
journal="JMIR Res Protoc",
year="2023",
month="Jul",
day="3",
volume="12",
pages="e40262",
keywords="adherence",
keywords="cost-effectiveness",
keywords="exercise",
keywords="osteogenesis imperfecta",
keywords="telemedicine",
abstract="Background: Osteogenesis imperfecta (OI) is a rare bone fragility disorder associated with muscle weakness. Individuals with OI may therefore benefit from exercise interventions aiming to improve muscle and bone strength. Given the rarity of OI, many patients do not have access to exercise specialists who are familiar with the disorder. As such, telemedicine, the provision of health care through technology to provide care at a distance, may be well suited for this population. Objective: The main objectives are (1) to investigate the feasibility and cost-effectiveness of 2 telemedicine approaches for the delivery of an exercise intervention for youth with OI and (2) to assess the impact of the exercise intervention on muscle function and cardiopulmonary fitness in youth with OI. Methods: Patients with OI type I (the mildest form of OI; n=12, aged 12-16 years) from a pediatric orthopedic tertiary hospital will be randomized to receive a 12-week remote exercise intervention in either (1) a supervised group (n=6), monitored every session, or (2) a follow-up group (n=6), receiving monthly progress update appointments. Participants will undergo the following pre- and postintervention evaluations: sit-to-stand test, push-up test, sit-up test, single-legged balance test, and a heel-rise test. Both groups will be given the same 12-week exercise regimen, which includes cardiovascular, resistance, and flexibility training. For each exercise training session involving the supervised group, a kinesiologist will provide instructions to participants through live video sessions using a teleconferencing application. On the other hand, the follow-up group will discuss their progress with the kinesiologist every 4 weeks over a teleconferencing video call. Feasibility will be assessed by recruitment, adherence, and completion rates. A cost-effectiveness analysis of both approaches will be computed. Changes in muscle function and cardiopulmonary fitness will be examined between the 2 groups, pre- and postintervention. Results: It is anticipated that the supervised group will have higher adherence and completion rates compared to the follow-up group, which may be associated with greater physiological benefits; however, it may not be as cost-effective compared to the follow-up approach. Conclusions: By determining the most feasible telemedicine approach, this study may serve as a basis for providing increased access to specialized adjunct therapies for individuals with rare disorders. International Registered Report Identifier (IRRID): PRR1-10.2196/40262 ",
doi="10.2196/40262",
url="https://www.researchprotocols.org/2023/1/e40262",
url="http://www.ncbi.nlm.nih.gov/pubmed/37399052"
}


@Article{info:doi/10.2196/40236,
author="Seon, Quinta
and Mady, Noor
and Yang, Michelle
and Karia, Maharshee
and Lashley, Myrna
and Sescu, Claudia
and Lalonde, Maud
and Puskas, Stephen
and Outerbridge, Joy
and Parent-Racine, Echo
and Pagiatakis, Catherine
and Gomez-Cardona, Liliana
and Jiang, Di
and Bouchard, St{\'e}phane
and Linnaranta, Outi",
title="A Virtual Reality--Assisted Cognitive Behavioral Therapy for and With Inuit in Qu{\'e}bec: Protocol for a Proof-of-Concept Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2023",
month="May",
day="24",
volume="12",
pages="e40236",
keywords="Inuit health",
keywords="randomized controlled trial",
keywords="emotion regulation",
keywords="virtual reality",
keywords="cognitive behavioral therapy",
keywords="co-design",
keywords="biofeedback",
keywords="cultural adaptation",
keywords="Indigenous",
abstract="Background: Emotion regulation is an ability related to psychological well-being; when dysregulated, individuals may have psychiatric symptoms and maladapted physiological responses. Virtual reality--assisted cognitive behavioral therapy (VR-CBT) is an effective psychotherapy to target and strengthen emotion regulation; however, it currently lacks cultural sensitivity and can be improved by adapting it to the cultural context of service users. During previous participatory research, we co-designed a culturally adapted cognitive behavioral therapy (CBT) manual and 2 virtual reality (VR) environments to function as a complement to therapy (VR-CBT) for Inuit who would like to access psychotherapy. Emotion regulation skill building will occur in virtual environments that have interactive components such as heart rate biofeedback. Objective: We describe a protocol for a proof-of-concept 2-arm randomized controlled trial (RCT) with Inuit (n=40) in Qu{\'e}bec. The primary aims of this research are to investigate the feasibility, benefits, and challenges of the culturally adapted VR-CBT intervention versus an established VR self-management that is available commercially. We will also investigate self-rated mental well-being and objective psychophysiological measures. Finally, we will use proof-of-concept data to identify suitable primary outcome measures, conduct power calculations in a larger trial for efficacy, and collect information about preferences for on-site or at-home treatment. Methods: Trial participants will be randomly assigned to an active condition or active control condition in a 1:1 ratio. Inuit aged 14 to 60 years will receive a culturally adapted and therapist-guided VR-CBT with biofeedback or a VR relaxation program with nonpersonalized guided components over a 10-week period. We will collect pre- and posttreatment measures of emotion regulation and biweekly assessments over the treatment and at 3-month follow-up. The primary outcome will be measured by the Difficulties in Emotion Regulation Scale (DERS-16) and a novel psychophysiological reactivity paradigm. Secondary measures include psychological symptoms and well-being via rating scales (eg, anxiety or depressive symptoms). Results: As this is the prospective registration of an RCT protocol, we do not yet report any results from the trial. Funding was confirmed in January 2020, and recruitment is expected to start in March 2023 and is set to finish in August 2025. The expected results are to be published in spring 2026. Conclusions: The proposed study responds to the community's desire for accessible and appropriate resources for psychological well-being, as it was developed in active collaboration with the Inuit community in Qu{\'e}bec. We will test feasibility and acceptance by comparing a culturally adapted, on-site psychotherapy with a commercial self-management program while incorporating novel technology and measurement in the area of Indigenous health. We also aim to fulfill the needs for RCT evidence of culturally adapted psychotherapies that are lacking in Canada. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN) 21831510; https://www.isrctn.com/ISRCTN21831510 International Registered Report Identifier (IRRID): PRR1-10.2196/40236 ",
doi="10.2196/40236",
url="https://www.researchprotocols.org/2023/1/e40236",
url="http://www.ncbi.nlm.nih.gov/pubmed/37223973"
}


@Article{info:doi/10.2196/45752,
author="Su, Ting
and Calvo, A. Rafael
and Jouaiti, Melanie
and Daniels, Sarah
and Kirby, Pippa
and Dijk, Derk-Jan
and della Monica, Ciro
and Vaidyanathan, Ravi",
title="Assessing a Sleep Interviewing Chatbot to Improve Subjective and Objective Sleep: Protocol for an Observational Feasibility Study",
journal="JMIR Res Protoc",
year="2023",
month="May",
day="11",
volume="12",
pages="e45752",
keywords="automated chatbot",
keywords="behavior analysis",
keywords="conversational agents",
keywords="older adults",
keywords="sleep disorders",
keywords="sleep interview",
abstract="Background: Sleep disorders are common among the aging population and people with neurodegenerative diseases. Sleep disorders have a strong bidirectional relationship with neurodegenerative diseases, where they accelerate and worsen one another. Although one-to-one individual cognitive behavioral interventions (conducted in-person or on the internet) have shown promise for significant improvements in sleep efficiency among adults, many may experience difficulties accessing interventions with sleep specialists, psychiatrists, or psychologists. Therefore, delivering sleep intervention through an automated chatbot platform may be an effective strategy to increase the accessibility and reach of sleep disorder intervention among the aging population and people with neurodegenerative diseases. Objective: This work aims to (1) determine the feasibility and usability of an automated chatbot (named MotivSleep) that conducts sleep interviews to encourage the aging population to report behaviors that may affect their sleep, followed by providing personalized recommendations for better sleep based on participants' self-reported behaviors; (2) assess the self-reported sleep assessment changes before, during, and after using our automated sleep disturbance intervention chatbot; (3) assess the changes in objective sleep assessment recorded by a sleep tracking device before, during, and after using the automated chatbot MotivSleep. Methods: We will recruit 30 older adult participants from West London for this pilot study. Each participant will have a sleep analyzer installed under their mattress. This contactless sleep monitoring device passively records movements, heart rate, and breathing rate while participants are in bed. In addition, each participant will use our proposed chatbot MotivSleep, accessible on WhatsApp, to describe their sleep and behaviors related to their sleep and receive personalized recommendations for better sleep tailored to their specific reasons for disrupted sleep. We will analyze questionnaire responses before and after the study to assess their perception of our proposed chatbot; questionnaire responses before, during, and after the study to assess their subjective sleep quality changes; and sleep parameters recorded by the sleep analyzer throughout the study to assess their objective sleep quality changes. Results: Recruitment will begin in May 2023 through UK Dementia Research Institute Care Research and Technology Centre organized community outreach. Data collection will run from May 2023 until December 2023. We hypothesize that participants will perceive our proposed chatbot as intelligent and trustworthy; we also hypothesize that our proposed chatbot can help improve participants' subjective and objective sleep assessment throughout the study. Conclusions: The MotivSleep automated chatbot has the potential to provide additional care to older adults who wish to improve their sleep in more accessible and less costly ways than conventional face-to-face therapy. International Registered Report Identifier (IRRID): PRR1-10.2196/45752 ",
doi="10.2196/45752",
url="https://www.researchprotocols.org/2023/1/e45752",
url="http://www.ncbi.nlm.nih.gov/pubmed/37166964"
}


@Article{info:doi/10.2196/43645,
author="Newby, Katie
and Kwah, Kayleigh
and Schumacher, Lauren
and Crutzen, Rik
and Bailey, V. Julia
and Jackson, J. Louise
and Bremner, Stephen
and Brown, E. Katherine",
title="An Intervention to Increase Condom Use Among Users of Sexually Transmitted Infection Self-sampling Websites (Wrapped):      Protocol for a Randomized Controlled Feasibility Trial",
journal="JMIR Res Protoc",
year="2023",
month="May",
day="11",
volume="12",
pages="e43645",
keywords="adolescent",
keywords="condom use",
keywords="digital health",
keywords="eHealth",
keywords="feasibility randomized controlled trial",
keywords="sexual health",
keywords="sexually transmitted infections",
keywords="STIs",
keywords="self-testing",
keywords="young people",
abstract="Background: Reducing the rates of sexually transmitted infections (STIs) among young people is a public health priority. The best way to avoid STIs from penetrative sex is to use a condom, but young people report inconsistent use. A missed opportunity to intervene to increase condom use is when young people access self-sampling kits for STIs through the internet. The potential of this opportunity is enhanced by the increasing numbers of young people being tested through this route every year in England. Hence, in a cocreation by young people, stakeholders, and researchers, Wrapped was developed----a fully automated, multicomponent, and interactive digital behavior change intervention developed for users of STI self-sampling websites, who are aged 16-24 years. Objective: This paper is a protocol for a feasibility randomized controlled trial (fRCT). The fRCT seeks to establish whether it is feasible to run a randomized controlled trial to test the effectiveness and cost-effectiveness of Wrapped. Wrapped aims to reduce the incidence of STIs through increasing correct and consistent use of condoms among users of STI self-sampling websites, who are aged 16-24 years. Methods: A 2-arm parallel-group randomized fRCT of Wrapped plus usual care, compared to usual care only (basic information on STIs and condom use), with a nested qualitative study. A minimum of 230 participants (aged 16-24 years) are recruited from an existing chlamydia self-sampling website. Participants are randomized into 1 of 2 parallel groups (1:1 allocation). Primary outcomes are the percentage of users recruited to the fRCT and the percentage of randomized participants who return a chlamydia self-sampling kit at month 12. Additionally, besides chlamydia positivity based on biological samples, surveys at baseline, month 3, month 6, and month 12, are used to assess condom use attitude, behavioral capability, self-efficacy, and intention, along with details of any partnered sexual activity and condom use, and health economic data. Nested qualitative interviews with trial participants are used to gain insight into the factors affecting recruitment and attrition. Results: Recruitment to the fRCT began in March 2021 and was completed in October 2021. Data collection was completed in December 2022. Conclusions: This feasibility study will provide data to inform the design of a future-definitive trial. This work is timely given a rapid rise in the use of internet testing for STIs and the sustained high levels of STIs among young people. Trial Registration: ISRCTN Registry ISRCTN17478654; http://www.isrctn.com/ISRCTN17478654 International Registered Report Identifier (IRRID): DERR1-10.2196/43645 ",
doi="10.2196/43645",
url="https://www.researchprotocols.org/2023/1/e43645",
url="http://www.ncbi.nlm.nih.gov/pubmed/37166958"
}


@Article{info:doi/10.2196/45887,
author="Reilly, D. Erin
and Kathawalla, Ummul-Kiram
and Robins, E. Hannah
and Heapy, A. Alicia
and Hogan, P. Timothy
and Waring, E. Molly
and Quigley, S. Karen
and Drebing, E. Charles
and Bickmore, Timothy
and Volonte, Matias
and Kelly, M. Megan",
title="An Online Acceptance and Mindfulness Intervention for Chronic Pain in Veterans: Development and Protocol for a Pilot Feasibility Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2023",
month="Mar",
day="7",
volume="12",
pages="e45887",
keywords="chronic pain",
keywords="randomized controlled trial",
keywords="usability",
keywords="acceptance and commitment therapy",
keywords="embodied conversational agent",
abstract="Background: In the veteran community, chronic pain is particularly prevalent and often debilitating. Until recently, veterans with chronic pain were offered primarily pharmacological intervention options, which rarely suffice and can also have negative health consequences. To better address chronic pain in veterans, the Veterans Health Administration has invested in novel, nonpharmacological behavior interventions that target both pain management and chronic pain--related functional issues. One approach, acceptance and commitment therapy (ACT) for chronic pain, is supported by decades of efficacy evidence for improving pain outcomes; however, ACT can be difficult to obtain owing to issues such as a lack of trained therapists or veterans having difficulty committing to the time and resources needed for the full clinician-led ACT protocol. Given the strong ACT evidence base combined with access limitations, we set out to develop and evaluate Veteran ACT for Chronic Pain (VACT-CP), an online program guided by an embodied conversational agent to improve pain management and functioning. Objective: The aims of this study are to develop, iteratively refine, and then conduct a pilot feasibility randomized controlled trial (RCT) of a VACT-CP group (n=20) versus a waitlist and treatment-as-usual control group (n=20). Methods: This research project includes 3 phases. In phase 1, our research team consulted with pain and virtual care experts, developed the preliminary VACT-CP online program, and conducted interviews with providers to obtain their feedback on the intervention. In phase 2, we incorporated feedback from phase 1 into the VACT-CP program and completed initial usability testing with veterans with chronic pain. In phase 3, we are conducting a small pilot feasibility RCT, with the primary outcome being assessment of usability of the VACT-CP system. Results: This study is currently in phase 3; recruitment for the RCT began in April 2022 and is expected to continue through April 2023. Data collection is expected to be completed by October 2023, with full data analysis completed by late 2023. Conclusions: The findings from this research project will provide information on the usability of the VACT-CP intervention, as well as secondary outcomes related to treatment satisfaction, pain outcomes (pain-related daily functioning and pain severity), ACT processes (pain acceptance, behavioral avoidance, and valued living), and mental and physical functioning. Trial Registration: ClinicalTrials.gov NCT03655132; https://clinicaltrials.gov/ct2/show/NCT03655132 International Registered Report Identifier (IRRID): DERR1-10.2196/45887 ",
doi="10.2196/45887",
url="https://www.researchprotocols.org/2023/1/e45887",
url="http://www.ncbi.nlm.nih.gov/pubmed/36881446"
}


@Article{info:doi/10.2196/44205,
author="Melia, Ruth
and Francis, Kady
and Duggan, Jim
and Bogue, John
and O'Sullivan, Mary
and Young, Karen
and Chambers, Derek
and McInerney, J. Shane
and O'Dea, Edmond
and Bernert, Rebecca",
title="Using a Safety Planning Mobile App to Address Suicidality in Young People Attending Community Mental Health Services in Ireland: Protocol for a Pilot Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2023",
month="Feb",
day="21",
volume="12",
pages="e44205",
keywords="suicide prevention",
keywords="mobile health",
keywords="mHealth",
keywords="safety planning",
keywords="SafePlan",
keywords="mobile phone",
abstract="Background: Over 700,000 people die by suicide annually, making it the fourth leading cause of death among those aged 15-29 years globally. Safety planning is recommended best practice when individuals at risk of suicide present to health services. A safety plan, developed in collaboration with a health care practitioner, details the steps to be taken in an emotional crisis. SafePlan, a safety planning mobile app, was designed to support young people experiencing suicidal thoughts and behaviors and to record their plan in a way that is accessible immediately and in situ. Objective: The aim of this study is to assess the feasibility and acceptability of the SafePlan mobile app for patients experiencing suicidal thoughts and behaviors and their clinicians within Irish community mental health services, examine the feasibility of study procedures for both patients and clinicians, and determine if the SafePlan condition yields superior outcomes when compared with the control condition. Methods: A total of 80 participants aged 16-35 years accessing Irish mental health services will be randomized (1:1) to receive the SafePlan app plus treatment as usual or treatment as usual plus a paper-based safety plan. The feasibility and acceptability of the SafePlan app and study procedures will be evaluated using both qualitative and quantitative methodologies. The primary outcomes are feasibility outcomes and include the acceptability of the app to participants and clinicians, the feasibility of delivery in this setting, recruitment, retention, and app use. The feasibility and acceptability of the following measures in a full randomized controlled trial will also be assessed: the Beck Scale for Suicide Ideation, Columbia Suicide Severity Rating Scale, Coping Self-Efficacy Scale, Interpersonal Needs Questionnaire, and Client Service Receipt Inventory. A repeated measures design with outcome data collected at baseline, post intervention (8 weeks), and at 6-month follow-up will be used to compare changes in suicidal ideation for the intervention condition relative to the waitlist control condition. A cost-outcome description will also be undertaken. Thematic analyses will be used to analyze the qualitative data gathered through semistructured interviews with patients and clinicians. Results: As of January 2023, funding and ethics approval have been acquired, and clinician champions across mental health service sites have been established. Data collection is expected to commence by April 2023. The submission of completed manuscript is expected by April 2025. Conclusions: The framework for Decision-making after Pilot and feasibility Trials will inform the decision to progress to a full trial. The results will inform patients, researchers, clinicians, and health services of the feasibility and acceptability of the SafePlan app in community mental health services. The findings will have implications for further research and policy regarding the broader integration of safety planning apps. Trial Registration: OSF Registries osf.io/3y54m; https://osf.io/3y54m International Registered Report Identifier (IRRID): PRR1-10.2196/44205 ",
doi="10.2196/44205",
url="https://www.researchprotocols.org/2023/1/e44205",
url="http://www.ncbi.nlm.nih.gov/pubmed/36809171"
}


@Article{info:doi/10.2196/42980,
author="Hays Weeks, C. Chelsea
and Moore, A. Alison
and Allison, Matthew
and Patrick, Kevin
and Bondi, W. Mark
and Nebeker, Camille
and Liu, T. Thomas
and Wing, David
and Higgins, Michael
and Hartman, J. Sheri
and Rissman, A. Robert
and Zlatar, Z. Zvinka",
title="The Independent Walking for Brain Health Intervention for Older Adults: Protocol for a Pilot Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2023",
month="Feb",
day="13",
volume="12",
pages="e42980",
keywords="older adults",
keywords="seniors",
keywords="real world",
keywords="real time",
keywords="digital health",
keywords="feasibility",
keywords="brain perfusion",
keywords="cognition",
keywords="adaptive intervention",
keywords="exercise",
keywords="clinical trial",
keywords="mechanisms",
abstract="Background: Extensive research suggests that physical activity (PA) is important for brain and cognitive health and may help to delay or prevent Alzheimer's disease and related dementias. Most PA interventions designed to improve brain health in older adults have been conducted in laboratory, gym, or group settings that require extensive resources and travel to the study site or group sessions. Research is needed to develop novel interventions that leverage mobile health (mHealth) technologies to help older adults increase their engagement in PA in free-living environments, reducing participant burden and increasing generalizability of research findings. Moreover, promoting engagement in moderate-to-vigorous PA (MVPA) may be most beneficial to brain health; thus, using mHealth to help older adults increase time spent in MVPA in free-living environments may help to offset the burden of Alzheimer's disease and related dementias and improve quality of life in older age. Objective: We developed a novel PA intervention that leverages mHealth to help older adults achieve more minutes of MVPA independently. This pilot study was a 12-week randomized controlled trial to investigate the feasibility of providing just-in-time (JIT) feedback about PA intensity during free-living exercise sessions to help older adults meet current PA recommendations (150 minutes per week of MVPA). Methods: Participants were eligible if they were cognitively healthy English speakers aged between 65 and 80 years without major cardiovascular, neurologic, or mental health conditions; could ambulate independently; and undergo magnetic resonance imaging. Enrollment occurred from October 2017 to March 2020. Participants randomized to the PA condition received an individualized exercise prescription and an mHealth device that provided heart rate--based JIT feedback on PA intensity, allowing them to adjust their behavior in real time to maintain MVPA during exercise sessions. Participants assigned to the healthy aging education condition received a reading prescription consisting of healthy aging topics and completed weekly quizzes based on the materials. Results: In total, 44 participants were randomized to the intervention. A follow-up manuscript will describe the results of the intervention as well as discuss screening, recruitment, adverse events, and participants' opinions regarding their participation in the intervention. Conclusions: The long-term goal of this intervention is to better understand how MVPA affects brain and cognitive health in the real world and extend laboratory findings to everyday life. This pilot randomized controlled trial was conducted to determine the feasibility of using JIT heart rate zone feedback to help older adults independently increase time spent in MVPA while collecting data on the plausible mechanisms of change (frontal and medial temporal cerebral blood flow and cardiorespiratory fitness) that may affect cognition (memory and executive function) to help refine a planned stage 2 behavioral trial. Trial Registration: ClinicalTrials.gov NCT03058146; https://clinicaltrials.gov/ct2/show/NCT03058146 International Registered Report Identifier (IRRID): DERR1-10.2196/42980 ",
doi="10.2196/42980",
url="https://www.researchprotocols.org/2023/1/e42980",
url="http://www.ncbi.nlm.nih.gov/pubmed/36535765"
}


@Article{info:doi/10.2196/39058,
author="Ko, Jisook
and Wang, Jing
and Chung, L. Misook
and Sharma, Kumar",
title="Examining the Individual Response to a Low-Sodium Diet in Patients with Hypertension: Protocol for a Pilot Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2023",
month="Feb",
day="13",
volume="12",
pages="e39058",
keywords="adherence to low-sodium diet intervention",
keywords="adherence",
keywords="metabolite profile",
keywords="salt sensitivity",
keywords="digital self-monitoring",
keywords="hypertension",
keywords="salt",
keywords="blood pressure",
keywords="sodium",
keywords="diet",
keywords="metabolite",
keywords="nutrition",
keywords="metabolomics",
keywords="precision medicine",
keywords="personalized",
keywords="personalization",
keywords="RCT",
keywords="randomized controlled trial",
keywords="genetics",
keywords="genomics",
keywords="chronic disease",
keywords="chronic condition",
keywords="urinary",
keywords="dietary",
keywords="dietary sodium",
keywords="hypertensive patient",
keywords="cardiovascular disease",
abstract="Background: Excessive dietary sodium intake is an independent risk factor for hypertension and cardiovascular disease (CVD). Despite the large body of evidence concerning the effects of dietary interventions on blood pressure (BP) and CVD outcomes, trials have often reported low adherence to decreased sodium intake, likely due in part to heterogeneous BP responses. To address the challenges, recent clinical findings suggested a precise and personalized dietary approach that seeks to deliver more preventive and practical dietary advice than the ``one-size-fits-all'' guidelines and weighs the personal risk of developing specific diseases. Objective: The purpose of this pilot randomized controlled trial was to test the feasibility and preliminary efficacy of integrating the use of mobile technology and metabolomics with a low-sodium diet intervention in patients with hypertension to develop personalized low-sodium diet programs. Additionally, the study will examine the associations of urine metabolites with urinary sodium levels and BP control based on the hypothesis that targeted urine metabolites. In this report, we describe the design and protocol of the pilot trial. Methods: A total of 40 patients with hypertension will be randomly assigned to either a 8-week low-sodium diet group (n=20) or a standard care group (n=20). Each week, intervention participants went through individual sessions with an interventionist via videoconferencing to discuss low-sodium diet regimens, patients' food choices, and BP tracks on mobile apps. The control group followed their usual care for hypertension management. All participants in both groups monitored diet and BP using mobile apps for 8 weeks. A 24-hour urinary sodium excretion for the estimation of dietary sodium intake, systolic, and diastolic BPs were measured at the baseline and at 8 weeks. The primary outcomes of this study include the feasibility of conducting a randomized controlled trial (RCT) by reporting recruitment, retention, and completion statistics. The preliminary effects of intervention will be tested by a generalized estimating equation model. Results: This pilot RCT study was approved by the institutional review board at the University of Texas Health San Antonio in January 2021. The first participant was enrolled in April 2021, and currently, 26 participants were enrolled. All data collection is expected to conclude by March 2023, with data analysis and study results ready for reporting by December 2023. Findings from this pilot RCT will further guide the team in planning a future large-scale study. Conclusions: The findings of this proposed study will establish a comprehensive knowledge base for future research and development of personalized dietary interventions to promote adherence to dietary strategies and self-management of chronic disease using the Precision Health approach for millions of Americans who are struggling with uncontrolled hypertension. Trial Registration: ClinicalTrials.gov NCT04764253; https://clinicaltrials.gov/ct2/show/NCT04764253 International Registered Report Identifier (IRRID): DERR1-10.2196/39058 ",
doi="10.2196/39058",
url="https://www.researchprotocols.org/2023/1/e39058",
url="http://www.ncbi.nlm.nih.gov/pubmed/36780210"
}


@Article{info:doi/10.2196/38362,
author="Helissey, Carole
and Cavallero, Sophie
and Mondot, Stanislas
and Parnot, Charles
and Yssaad, Halima
and Becherirat, Selma
and Guitard, Nathalie
and Thery, H{\'e}l{\`e}ne
and Schernberg, Antoine
and Breitwiller, Hugo
and Chargari, Cyrus
and Francois, Sabine",
title="Correlation Between Serum and Urine Biomarkers and the Intensity of Acute Radiation Cystitis in Patients Treated With Radiation Therapy for Localized Prostate Cancer: Protocol for the Radiotoxicity Bladder Biomarkers (RABBIO) Study",
journal="JMIR Res Protoc",
year="2023",
month="Jan",
day="10",
volume="12",
pages="e38362",
keywords="radiation cystitis",
keywords="radiotoxicity",
keywords="urine",
keywords="bladder",
keywords="serum",
keywords="quality of life",
keywords="remote monitoring",
keywords="biomarker",
keywords="prostate",
keywords="cancer",
keywords="immunosorbent",
keywords="urology",
keywords="cytometry",
keywords="protocol",
keywords="telehealth",
keywords="telemedicine",
keywords="health platform",
keywords="online platform",
keywords="monitor",
keywords="digital health",
keywords="radiotherapy",
keywords="radiation",
keywords="risk",
keywords="inflammation",
keywords="inflammatory",
keywords="sequencing",
keywords="biopsy",
keywords="biopsies",
keywords="gene expression",
keywords="protein",
keywords="microbiology",
keywords="cystitis",
keywords="microbe",
keywords="microbiota",
keywords="RNA",
keywords="proteomics",
keywords="assay",
keywords="algorithm",
keywords="oncology",
keywords="radiology",
keywords="radiation therapy",
keywords="prostate cancer",
keywords="diagnostic",
abstract="Background: Despite improvements in radiation techniques, pelvic radiotherapy is responsible for acute and delayed bladder adverse events, defined as radiation cystitis. The initial symptoms of bladder injury secondary to pelvic irradiation are likely to occur during treatment or within 3 months of radiotherapy in approximately 50\% of irradiated patients, and have a significant impact on their quality of life. The pathophysiology of radiation cystitis is not well understood, particularly because of the risk of complications associated with access to bladder tissue after irradiation, which limits our ability to study this process and develop treatments. Objective: It is an original study combining digital data collection to monitor patients' symptoms and biological markers during irradiation. The main objective of our study is to evaluate the correlation of biological biomarkers with the intensity of acute radiation cystitis and the quality of life of patients, assessed with the digital telemonitoring platform Cureety. Methods: Patients with intermediate-risk localized prostate cancer who are eligible for localized radiotherapy will be included. Inflammatory biomarkers will be analyzed in urine and blood samples before the start of radiotherapy and at weeks 4, 12, and 48 of irradiation, through quantitative methods such as a multiplex Luminex assay, flow cytometry, and enzyme-linked immunosorbent assay. We will also characterize the patients' gut and urine microbiota composition using 16S ribosomal RNA sequencing technology. Between sample collection visits, patients will complete various questionnaires related to radiation cystitis symptoms (using the International Prostate Symptom Score), adverse events, and quality of life (using the Functional Assessment of Cancer Therapy--Prostate questionnaire), using the Cureety digital remote monitoring platform. Upon receipt of the questionnaires, an algorithm will process the information and classify patients in accordance with the severity of symptoms and adverse events reported on the basis of Common Terminology Criteria for Adverse Events and International Prostate Symptom Score standards. This will allow us to correlate levels of urinary, blood, and fecal biomarkers with the severity of acute radiation cystitis symptoms and patient-reported quality of life. Results: The study started in March 2022. We estimate a recruitment period of approximately 18 months, and the final results are expected in 2024. Conclusions: This prospective study is the first to explore the overexpression of inflammatory proteins in fluid biopsies from patients with symptoms of acute radiation cystitis. In addition, the 1-year follow-up after treatment will allow us to predict which patients are at risk of late radiation cystitis and to refer them for radioprotective treatment. The results of this study will allow us to develop strategies to limit radiation damage to the bladder and improve the quality of life of patients. Trial Registration: ClinicalTrials.gov NCT05246774; https://clinicaltrials.gov/ct2/show/NCT05246774?term=NCT05246774 International Registered Report Identifier (IRRID): DERR1-10.2196/38362 ",
doi="10.2196/38362",
url="https://www.researchprotocols.org/2023/1/e38362",
url="http://www.ncbi.nlm.nih.gov/pubmed/36626198"
}


@Article{info:doi/10.2196/39148,
author="Zougar, Mohammad
and Todd, Chris
and McGarrigle, Lisa
and Stanmore, Emma",
title="MIRA Rehab Exergames for Older Male Residents in a Care Home Center in Saudi Arabia: Protocol for a Feasibility Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2022",
month="Dec",
day="20",
volume="11",
number="12",
pages="e39148",
keywords="exergame",
keywords="balance",
keywords="older adults",
keywords="telerehabilitation",
keywords="feasibility",
keywords="elderly care",
keywords="aging",
keywords="elderly population",
keywords="rehabilitation",
keywords="virtual therapy",
keywords="digital rehabilitation",
keywords="physical activity",
abstract="Background: Physical activity leads to improvements in morbidity, mortality, and quality of life, especially when it is progressive, challenging, and regular. There is strong evidence that strength and balance exercises decrease the risk of falling. However, traditional exercises may be tedious and not very motivating for participants. Exergames have been found to increase engagement and enjoyment for older users. Objective: This study will conduct a feasibility randomized controlled trial (RCT) on the use of MIRA Rehab Exergames among older male residents in a care home setting in Saudi Arabia. A sample of 30 eligible participants will be recruited to meet feasibility study requirements. Methods: We will recruit 38 residents in the care home who will be randomly allocated to either an intervention or a control group. The intervention participants will perform gamified exercises using the MIRA telerehabilitation platform (30 minutes 3 times per week for 6 weeks). The control group will receive educational advice based on booklets of the Otago exercise program and be encouraged to exercise (30 minutes 3 times per week for 6 weeks). Participants will be assessed at weeks 0, 6, and 12. Assessments will include feasibility measures (eligibility, recruitment and attrition rates, and practicalities of data collection methods) and participant outcome measures (balance, strength, mobility, adherence, quality of life, fear of falling, depression, acceptability, and usability). Results: Data collection started in November 2021 and ended in March 2022. The study is currently in the data analysis stage, which commenced in May 2022. The findings from this feasibility RCT will be used to design a definitive RCT to test whether the MIRA Rehab Exergame program benefits older people in Saudi Arabia who may not like participating in traditional exercise programs and may be unwilling or unable to leave their homes. Conclusions: This study will contribute to our understanding of how to recruit in this specific population and provide information to inform the design of a future RCT. International Registered Report Identifier (IRRID): DERR1-10.2196/39148 ",
doi="10.2196/39148",
url="https://www.researchprotocols.org/2022/12/e39148",
url="http://www.ncbi.nlm.nih.gov/pubmed/36538360"
}


@Article{info:doi/10.2196/38536,
author="Kondylakis, Haridimos
and Chicchi Giglioli, Alice Irene
and Katehakis, G. Dimitrios
and Aldemir, Hatice
and Zikas, Paul
and Papagiannakis, George
and Hors-Fraile, Santiago
and Gonz{\'a}lez-Sanz, L. Pedro
and Apostolakis, C. Konstantinos
and Stephanidis, Constantine
and N{\'u}{\~n}ez-Benjumea, J. Francisco
and Ba{\~n}os-Rivera, M. Rosa
and Fernandez-Luque, Luis
and Kouroubali, Angelina",
title="A Digital Health Intervention for Stress and Anxiety Relief in Perioperative Care: Protocol for a Feasibility Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2022",
month="Nov",
day="29",
volume="11",
number="11",
pages="e38536",
keywords="CARINAE",
keywords="digital health",
keywords="perioperative process",
keywords="patient empowerment",
keywords="stress and anxiety management",
keywords="mobile health",
keywords="mHealth",
keywords="virtual reality",
keywords="VR",
keywords="health recommender system",
keywords="HRS",
abstract="Background: Stress and anxiety are psychophysiological responses commonly experienced by patients during the perioperative process that can increase presurgical and postsurgical complications to a comprehensive and positive recovery. Preventing and intervening in stress and anxiety can help patients achieve positive health and well-being outcomes. Similarly, the provision of education about surgery can be a crucial component and is inversely correlated with preoperative anxiety levels. However, few patients receive stress and anxiety relief support before surgery, and resource constraints make face-to-face education sessions untenable. Digital health interventions can be helpful in empowering patients and enhancing a more positive experience. Digital health interventions have been shown to help patients feel informed about the possible benefits and risks of available treatment options. However, they currently focus only on providing informative content, neglecting the importance of personalization and patient empowerment. Objective: This study aimed to explore the feasibility of a digital health intervention called the Adhera CARINAE Digital Health Program, designed to provide evidence-based, personalized stress- and anxiety-management methods enabled by a comprehensive digital ecosystem that incorporates wearable, mobile, and virtual reality technologies. The intervention program includes the use of advanced data-driven techniques for tailored patient education and lifestyle support. Methods: The trial will include 5 hospitals across 3 European countries and will use a randomized controlled design including 30 intervention participants and 30 control group participants. The involved surgeries are cardiopulmonary and coronary artery bypass surgeries, cardiac valve replacement, prostate or bladder cancer surgeries, hip and knee replacement, maxillofacial surgery, or scoliosis. The control group will receive standard care, and the intervention group will additionally be exposed to the digital health intervention program. Results: The recruitment process started in January 2022 and has been completed. The primary impact analysis is currently ongoing. The expected results will be published in early 2023. Conclusions: This manuscript details a comprehensive protocol for a study that will provide valuable information about the intervention program, such as the measurement of comparative intervention effects on stress; anxiety and pain management; and usability by patients, caregivers, and health care professionals. This will contribute to the evidence planning process for the future adoption of diverse digital health solutions in the field of surgery. Trial Registration: ClinicalTrials.gov NCT05184725; https://www.clinicaltrials.gov/ct2/show/NCT05184725 International Registered Report Identifier (IRRID): DERR1-10.2196/38536 ",
doi="10.2196/38536",
url="https://www.researchprotocols.org/2022/11/e38536",
url="http://www.ncbi.nlm.nih.gov/pubmed/36445734"
}


@Article{info:doi/10.2196/40817,
author="Tatar, Ovidiu
and Abdel-Baki, Amal
and Wittevrongel, Anne
and Lecomte, Tania
and Copeland, Jan
and Lachance-Touchette, Pamela
and Coronado-Montoya, Stephanie
and C{\^o}t{\'e}, Jos{\'e}
and Crockford, David
and Dubreucq, Simon
and L'Heureux, Sophie
and Ouellet-Plamondon, Clair{\'e}laine
and Roy, Marc-Andr{\'e}
and Tibbo, G. Philip
and Villeneuve, Marie
and Jutras-Aswad, Didier",
title="Reducing Cannabis Use in Young Adults With Psychosis Using iCanChange, a Mobile Health App: Protocol for a Pilot Randomized Controlled Trial (ReCAP-iCC)",
journal="JMIR Res Protoc",
year="2022",
month="Nov",
day="25",
volume="11",
number="11",
pages="e40817",
keywords="psychological intervention",
keywords="behavioral intervention",
keywords="cannabis misuse",
keywords="cannabis use disorder",
keywords="drug use",
keywords="substance use",
keywords="cannabis",
keywords="marijuana",
keywords="young adult",
keywords="teenager",
keywords="psychosis",
keywords="schizophrenia",
keywords="mental health",
keywords="disorder",
keywords="dual diagnosis",
keywords="telemedicine",
keywords="mobile health",
keywords="mHealth",
keywords="digital health",
keywords="eHealth",
keywords="app",
keywords="smartphone",
keywords="mobile phone",
keywords="randomized controlled trial",
keywords="RCT",
keywords="cognitive behavioral therapy",
keywords="CBT",
keywords="motivational interviewing",
keywords="behavioral management",
keywords="self-management",
keywords="drug",
keywords="substance",
keywords="protocol",
keywords="interview",
keywords="behavior",
keywords="outcome",
abstract="Background: Cannabis use is the most prevalent among adolescents and young adults; frequent consumption is associated with cannabis use disorder (CUD) and psychosis, with a high prevalence (up to 50\%) of CUD in individuals with first-episode psychosis (FEP). Early Intervention Services (EIS) for psychosis include face-to-face psychosocial interventions for CUD, because reducing or discontinuing cannabis use improves clinical and health care service use outcomes. However, multiple barriers (eg, staff availability and limited access to treatment) can hinder the implementation of these interventions. Mobile health (mHealth) interventions may help circumvent some of these barriers; however, to date, no study has evaluated the effects of mHealth psychological interventions for CUD in individuals with FEP. Objective: This study describes the protocol for a pilot randomized controlled trial using a novel mHealth psychological intervention (iCanChange [iCC]) to address CUD in young adults with FEP. iCC was developed based on clinical evidence showing that in individuals without psychosis, integrating the principles of cognitive behavioral therapy, motivational interviewing, and behavioral self-management approaches are effective in improving cannabis use--related outcomes. Methods: Consenting individuals (n=100) meeting the inclusion criteria (eg, aged 18-35 years with FEP and CUD) will be randomly allocated in a 1:1 ratio to the intervention (iCC+modified EIS) or control (EIS) group. The iCC is fully automatized and contains 21 modules that are completed over a 12-week period and 3 booster modules available during the 3-month follow-up period. Validated self-report measures will be taken via in-person assessments at baseline and at 6, 12 (end point), and 24 weeks (end of trial); iCC use data will be collected directly from the mobile app. Primary outcomes are intervention completion and trial retention rates, and secondary outcomes are cannabis use quantity, participant satisfaction, app use, and trial recruiting parameters. Exploratory outcomes include severity of psychotic symptoms and CUD severity. For primary outcomes, we will use the chi-square test using data collected at week 12. We will consider participation in iCC acceptable if ?50\% of the participants complete at least 11 out of 21 intervention modules and the trial feasible if attrition does not reach 50\%. We will use analysis of covariance and mixed-effects models for secondary outcomes and generalized estimating equation multivariable analyses for exploratory outcomes. Results: Recruitment began in July 2022, and data collection is anticipated to be completed in July 2024. The main results are expected to be submitted for publication in 2024. We will engage patient partners and other stakeholders in creating a multifaceted knowledge translation plan to reach a diverse audience. Conclusions: If feasible, this study will provide essential data for a larger-scale efficacy trial of iCC on cannabis use outcomes in individuals with FEP and CUD. Trial Registration: ClinicalTrials.gov NCT05310981; https://www.clinicaltrials.gov/ct2/show/NCT05310981 International Registered Report Identifier (IRRID): PRR1-10.2196/40817 ",
doi="10.2196/40817",
url="https://www.researchprotocols.org/2022/11/e40817",
url="http://www.ncbi.nlm.nih.gov/pubmed/36427227"
}


@Article{info:doi/10.2196/41445,
author="Amarti, Khadicha
and Schulte, J. Mieke H.
and Kleiboer, Annet
and Van Genugten, Rosalie Claire
and Oudega, Mardien
and Sonnenberg, Caroline
and Gon{\c{c}}alves, C. Gon{\c{c}}alo
and Rocha, Artur
and Riper, Heleen",
title="Feasibility of Digital Cognitive Behavioral Therapy for Depressed Older Adults With the Moodbuster Platform: Protocol for 2 Pilot Feasibility Studies",
journal="JMIR Res Protoc",
year="2022",
month="Oct",
day="25",
volume="11",
number="10",
pages="e41445",
keywords="iCBT",
keywords="study protocol",
keywords="feasibility study",
keywords="acceptance",
keywords="satisfaction",
keywords="usability",
keywords="engagement",
keywords="depression severity",
keywords="older adults",
abstract="Background: Internet-based interventions can be effective in the treatment of depression. However, internet-based interventions for older adults with depression are scarce, and little is known about their feasibility and effectiveness. Objective: To present the design of 2 studies aiming to assess the feasibility of internet-based cognitive behavioral treatment for older adults with depression. We will assess the feasibility of an online, guided version of the Moodbuster platform among depressed older adults from the general population as well as the feasibility of a blended format (combining integrated face-to-face sessions and internet-based modules) in a specialized mental health care outpatient clinic. Methods: A single-group, pretest-posttest design will be applied in both settings. The primary outcome of the studies will be feasibility in terms of (1) acceptance and satisfaction (measured with the Client Satisfaction Questionnaire-8), (2) usability (measured with the System Usability Scale), and (3) engagement (measured with the Twente Engagement with eHealth Technologies Scale). Secondary outcomes include (1) the severity of depressive symptoms (measured with the 8-item Patient Health Questionnaire depression scale), (2) participant and therapist experience with the digital technology (measured with qualitative interviews), (3) the working alliance between patients and practitioners (from both perspectives; measured with the Working Alliance Inventory--Short Revised questionnaire), (4) the technical alliance between patients and the platform (measured with the Working Alliance Inventory for Online Interventions--Short Form questionnaire), and (5) uptake, in terms of attempted and completed modules. A total of 30 older adults with mild to moderate depressive symptoms (Geriatric Depression Scale 15 score between 5 and 11) will be recruited from the general population. A total of 15 older adults with moderate to severe depressive symptoms (Geriatric Depression Scale 15 score between 8 and 15) will be recruited from a specialized mental health care outpatient clinic. A mixed methods approach combining quantitative and qualitative analyses will be adopted. Both the primary and secondary outcomes will be further explored with individual semistructured interviews and synthesized descriptively. Descriptive statistics (reported as means and SDs) will be used to examine the primary and secondary outcome measures. Within-group depression severity will be analyzed using a 2-tailed, paired-sample t test to investigate differences between time points. The interviews will be recorded and analyzed using thematic analysis. Results: The studies were funded in October 2019. Recruitment started in September 2022. Conclusions: The results of these pilot studies will show whether this platform is feasible for use by the older adult population in a blended, guided format in the 2 settings and will represent the first exploration of the size of the effect of Moodbuster in terms of decreased depressive symptoms. International Registered Report Identifier (IRRID): PRR1-10.2196/41445 ",
doi="10.2196/41445",
url="https://www.researchprotocols.org/2022/10/e41445",
url="http://www.ncbi.nlm.nih.gov/pubmed/36282565"
}


@Article{info:doi/10.2196/37626,
author="Steen-Olsen, Balch Emma
and Pappot, Helle
and Green, Allan
and Langberg, Henning
and Holl{\"a}nder-Mieritz, Cecilie",
title="Feasibility of Monitoring Patients Who Have Cancer With a Smart T-shirt: Protocol for the OncoSmartShirt Study",
journal="JMIR Res Protoc",
year="2022",
month="Oct",
day="3",
volume="11",
number="10",
pages="e37626",
keywords="biometric sensor technology",
keywords="cancer",
keywords="home monitoring",
keywords="patient-generated health data",
keywords="sensor",
keywords="smart t-shirt",
keywords="remote monitoring",
keywords="adolescent",
keywords="protocol",
keywords="patient",
keywords="youth",
keywords="health care professional",
keywords="cancer treatment",
abstract="Background: Studies have shown that there may be dissimilar perceptions on symptoms or side effects between patients with cancer and health care professionals. This may lead to symptomatic patients notifying the clinic irregularly or not telling the clinic at all. Wearables could help identify symptoms earlier. Patients with low socioeconomic status and less self-awareness of their health may benefit from this. A new design of wearables is a smart t-shirt that, with embedded sensors, provides measurement flows such as electrocardiogram, thoracic and abdominal respiration, and temperature. Objective: This study evaluates the feasibility of using a smart t-shirt for home monitoring of biometric sensor data in adolescent and young adult and elderly patients during cancer treatment. Methods: The OncoSmartShirt study is an explorative study investigating the feasibility of using the Chronolife smart t-shirt during cancer treatment. This smart t-shirt is designed with multiple fully embedded sensors and electrodes that engender 6 different measurement flows continuously. A total of 20 Danish patients with cancer ?18 years old in antineoplastic treatment at Department of Oncology Rigshospitalet Denmark will be recruited from all cancer wards, whether patients are in curative or palliative care. Of these 20 patients, 10 (50\%) will be <39 years old, defined as adolescent and young adult, and 10 (50\%) will be patients >65 years old, defined as elderly. Consenting patients will be asked to wear a smart t-shirt daily for 2 weeks during their treatment course. Results: The primary outcome is to determine if it is feasible to wear a smart t-shirt throughout the day (preferably 8 hours per day) for 2 weeks. Inclusion of patients started in March 2022. Conclusions: The study will assess the feasibility of using the Chronolife smart t-shirt for home monitoring of vital parameters in patients with cancer during their treatment and bring new insights into how wearables and biometric data can be used as part of symptom or side-effect recognition in patients with cancer during treatment, with the aim to increase patients' quality of life. Trial Registration: ClinicalTrials.gov NCT05235594; https://beta.clinicaltrials.gov/study/NCT05235594 International Registered Report Identifier (IRRID): PRR1-10.2196/37626 ",
doi="10.2196/37626",
url="https://www.researchprotocols.org/2022/10/e37626",
url="http://www.ncbi.nlm.nih.gov/pubmed/36190744"
}


@Article{info:doi/10.2196/37849,
author="Michalsen, Henriette
and Wangberg, C. Silje
and Hartvigsen, Gunnar
and Henriksen, Andr{\'e}
and Pettersen, Gunn
and Jaccheri, Letizia
and Jahnsen, Birgitta Reidun
and Thrane, Gyrd
and Arntzen, Cathrine
and Anke, Audny",
title="mHealth Support to Stimulate Physical Activity in Individuals With Intellectual Disability: Protocol for a Mixed Methods Pilot Study",
journal="JMIR Res Protoc",
year="2022",
month="Sep",
day="15",
volume="11",
number="9",
pages="e37849",
keywords="intellectual disability",
keywords="physical activity",
keywords="technology",
keywords="mHealth",
keywords="mobile health",
keywords="exercise",
keywords="protocol",
keywords="pilot study",
keywords="trial",
keywords="caregivers",
abstract="Background: Several studies have shown that individuals with intellectual disabilities (IDs) have low levels of physical activity (PA), and intervention studies on PA suggest inconsistent evidence. The use of technology as a means of motivation for PA has yet to be extensively explored and needs to be further investigated. Objective: We aim to assess the feasibility and acceptability of procedures for an intervention arm in a future trial on mobile health (mHealth) to support PA for individuals with IDs. In addition, we aim to examine how the use of technology can influence motivation for PA among participants, their caregivers, and staff members. Methods: A mixed methods pilot study of an intervention arm will be carried out in a planned randomized controlled trial (RCT). Ten participants with ID and their caregivers or a staff member will be included. Information will always be provided by a caregiver or a staff member, or participants with ID if possible. Assessments will be carried out at baseline, follow-up after 4 weeks, and 12 weeks, and include questionnaires on PA, social support, self-efficacy, and challenging behavior. PA will be measured with 2 different activity trackers (Fitbit and Axivity) for 1 week at all assessments. Feasibility will be assessed as recruitment and adherence rate, missing data, usability of the motivational mHealth tool, and estimates of effectiveness. Acceptability of study procedures, activity measures, and motivation for participation in PA will be additionally assessed with qualitative methods at the end of the intervention. Results: Enrollment commenced in May 2021. Data collection was completed in March 2022. Conclusions: This pilot study will evaluate the feasibility and acceptability of study procedures of the intervention arm of a planned RCT to address feasibility issues, improve study procedures, and estimate effectiveness of the study measures. How the use of technology can influence motivation for PA will also be examined, which can help guide and improve future PA interventions involving the use of technology. Trial Registration: ClinicalTrials.gov NCT04929106; https://clinicaltrials.gov/ct2/show/NCT04929106 International Registered Report Identifier (IRRID): DERR1-10.2196/37849 ",
doi="10.2196/37849",
url="https://www.researchprotocols.org/2022/9/e37849",
url="http://www.ncbi.nlm.nih.gov/pubmed/36107473"
}


@Article{info:doi/10.2196/37822,
author="Puccinelli, Marc
and Seay, Julia
and Otto, Amy
and Garcia, Sofia
and Crane, E. Tracy
and Benzo, M. Roberto
and Solle, Natasha
and Mustanski, Brian
and Merchant, Nipun
and Safren, A. Steven
and Penedo, J. Frank",
title="An Adapted Cognitive Behavioral Stress and Self-management Intervention for Sexual Minority Men Living With HIV and Cancer Using the SmartManage eHealth Platform: Protocol and Study Design",
journal="JMIR Res Protoc",
year="2022",
month="Jul",
day="18",
volume="11",
number="7",
pages="e37822",
keywords="intervention",
keywords="HIV",
keywords="cancer",
keywords="participant",
keywords="SmartManage",
keywords="cognitive behavioral stress and self-management",
abstract="Background: Sexual minority men are disproportionately affected by HIV. Medical advances in HIV treatment have extended life expectancy, and as this group ages, medical and psychological challenges become more prominent. Older people with HIV experience a higher incidence of cancer and other comorbidities; these burdens along with sexual minority stress can strain coping resources and diminish health-related quality of life. Interventions such as cognitive behavioral stress and self-management (CBSM) can mitigate some of this burden; however, no manualized, eHealth-based interventions have focused on the unique needs of sexual minority men living with HIV and cancer. Objective: This study aims to refine and finalize a web-based, CBSM-based intervention to meet the unique needs of this population, including sexual health, comanagement of 2 chronic conditions, and coping with sexual minority stress. Methods: This mixed methods study used a previously completed qualitative phase (n=6) to inform the development of a web-based platform and intervention called SmartManage. The pilot phase study (n=50) involved randomization (1:1) into either 10 sessions of adapted CBSM or an attention control health promotion. Both conditions used the SmartManage platform, a web-based eHealth program designed to deliver CBSM and health promotion content and host live groups. Feasibility and acceptability (eg, rates of participant engagement and retention) were the primary outcomes. Results: Participant-related activities are expected to be completed by November 2022, and results are expected to be submitted for publication by February 2023. Conclusions: We hypothesize that participants would find the intervention acceptable (compared with engagement and retention rates observed in similar CBSM studies). We also hypothesize that participants receiving the SmartManage intervention would have reduced symptom burden and improved health-related quality of life before and after treatment compared with those who do not. International Registered Report Identifier (IRRID): DERR1-10.2196/37822 ",
doi="10.2196/37822",
url="https://www.researchprotocols.org/2022/7/e37822",
url="http://www.ncbi.nlm.nih.gov/pubmed/35849435"
}


@Article{info:doi/10.2196/34255,
author="Litchman, L. Michelle
and Kwan, M. Bethany
and Zittleman, Linda
and Simonetti, Juliana
and Iacob, Eli
and Curcija, Kristen
and Neuberger, Julie
and Latendress, Gwen
and Oser, K. Tamara",
title="A Telehealth Diabetes Intervention for Rural Populations: Protocol for a Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2022",
month="Jun",
day="14",
volume="11",
number="6",
pages="e34255",
keywords="diabetes",
keywords="rural",
keywords="telehealth",
keywords="implementation science",
keywords="community-based participatory research",
keywords="Spanish",
keywords="implementation",
keywords="community",
keywords="participatory",
keywords="protocol",
keywords="randomized controlled trial",
keywords="intervention",
keywords="adapt",
keywords="framework",
abstract="Background: Diabetes self-management education and support (DSMES) is a crucial component of diabetes care associated with improved clinical, psychosocial, and behavioral outcomes. The American Association of Diabetes Care and Education Specialists, the American Diabetes Association, and the American Academy of Family Physicians all recommend DSMES yet accessing linguistically and culturally appropriate DSMES is challenging in rural areas. The Diabetes One-Day (D1D) program is an established DSMES group intervention that has not been adapted or evaluated in rural communities. Objective: The specific aims of this paper are (1) to adapt the existing D1D program for use in rural communities, called rural D1D (R-D1D); and (2) to conduct a patient-level randomized controlled trial to examine the effects of R-D1D and standard patient education, guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. Methods: This is a protocol for a pilot type II hybrid implementation-effectiveness trial of a culturally adapted virtual DSMES program for rural populations, R-D1D. We will use Boot Camp Translation, a process grounded in the principles of community-based participatory research, to adapt an existing DSMES program for rural populations, in both English and Spanish. Participants at 2 rural primary care clinics (4 cohorts of N=16 plus care partners, 2 in English and 2 in Spanish) will be randomized to the intervention or standard education control. The evaluation is guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. Patient-level effectiveness outcomes (hemoglobin A1c, diabetes distress, and diabetes self-care behaviors) will be assessed using patient-reported outcomes measures and a home A1c test kit. Practice-level and patient-level acceptability and feasibility will be assessed using surveys and interviews. Results: This study is supported by the National Institute of Nursing. The study procedures were approved, and the adaptation processes have been completed. Recruitment and enrollment started in July 2021. Conclusions: To our knowledge, this will be the first study to evaluate both effectiveness and implementation outcomes for virtually delivered DSMES, culturally adapted for rural populations. This research has implications for delivery to other rural locations where access to specialty diabetes care is limited. Trial Registration: ClinicalTrials.gov NCT04600622; https://clinicaltrials.gov/ct2/show/NCT04600622 International Registered Report Identifier (IRRID): DERR1-10.2196/34255 ",
doi="10.2196/34255",
url="https://www.researchprotocols.org/2022/6/e34255",
url="http://www.ncbi.nlm.nih.gov/pubmed/35700026"
}


@Article{info:doi/10.2196/36845,
author="Daniels, Joseph
and Peters, H. Remco P.
and Medina-Marino, Andrew
and Bongo, Cikizwa
and Stephenson, Rob",
title="A Skills-Based HIV Serostatus Disclosure Intervention for Sexual Minority Men in South Africa: Protocol for Intervention Adaptation and a Pilot Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2022",
month="May",
day="16",
volume="11",
number="5",
pages="e36845",
keywords="gay",
keywords="bisexual",
keywords="men who have sex with men",
keywords="HIV intervention adaptation",
keywords="videoconference delivery",
keywords="HIV",
keywords="public health",
keywords="mobile phone",
abstract="Background: Gay, bisexual, and other men who have sex with men (GBMSM) living with HIV have low antiretroviral treatment adherence in South Africa due to limited skills in managing disclosure and prevention behaviors with sexual and romantic partners. As a result, there is a high HIV transmission risk within HIV-discordant partnerships, but an existing intervention may address these outcomes, if adapted effectively. Healthy Relationships (HR) is a behavioral intervention that was originally delivered in groups and in person over 5 sessions to develop coping skills for managing HIV-related stress and sexually risky situations, enhance decision-making skills for HIV disclosure to partners, and establish and maintain safer sex practices with partners. HR effectively improves prevention behaviors but has yet to be tailored to a non-US context. Objective: We aim to adapt HR into a new culturally grounded intervention entitled Speaking Out \& Allying Relationships for GBMSM and then assess its feasibility in Eastern Cape, South Africa. Methods: The study will have 2 aims. For aim 1---adaptation---we will use a human-centered design approach. Initial intervention tailoring will involve integrating Undetectable=Untransmittable and pre-exposure prophylaxis education, developing intervention content for a videoconference format, and designing role-plays and movies for skill building based on preliminary data. Afterward, interviews and surveys will be administered to GBMSM to assess intervention preferences, and a focus group will be conducted with health care providers and information technology experts to assess the intervention's design. Finally, a usability test will be performed to determine functionality and content understanding. Participants will be GBMSM living with HIV (n=15) who are in a relationship and health care providers and information technology (n=7) experts working in HIV care and programming with this population. For aim 2, we will examine the feasibility of the adapted intervention by using a pilot randomized control design. There will be 60 individuals per arm. Feasibility surveys and interviews will be conducted with the intervention arm, and behavioral and biomedical assessments for relationship and treatment adherence outcomes will be collected for both arms. All participants will be GBMSM living with HIV who are in a relationship with an HIV-negative or unknown status partner. Results: Intervention adaptation began in August 2021. Initial tailoring and the refining of GBMSM intervention preferences were completed in December 2021. Usability and feasibility assessments are due to be completed by March 2022 and February 2024, respectively. Conclusions: GBMSM need efficacious interventions that tackle partnership dynamics, HIV prevention, and treatment outcomes for antiretroviral treatment adherence and viral suppression in South Africa. Harnessing everyday technology use for social networking (eg, videoconferences), Undetectable=Untransmittable education, and pre-exposure prophylaxis to update an existing intervention for South African GBMSM has the potential to strengthen relationship communication about HIV treatment and prevention and, in turn, improve outcomes. International Registered Report Identifier (IRRID): DERR1-10.2196/36845 ",
doi="10.2196/36845",
url="https://www.researchprotocols.org/2022/5/e36845",
url="http://www.ncbi.nlm.nih.gov/pubmed/35576574"
}


@Article{info:doi/10.2196/33982,
author="Budhwani, Henna
and Sharma, Vinita
and Long, Dustin
and Simpson, Tina",
title="Developing a Clinic-Based, Vaccine-Promoting Intervention for African American Youth in Rural Alabama: Protocol for a Pilot Cluster-Randomized Controlled Implementation Science Trial",
journal="JMIR Res Protoc",
year="2022",
month="Apr",
day="8",
volume="11",
number="4",
pages="e33982",
keywords="human papillomavirus",
keywords="COVID-19",
keywords="vaccine",
keywords="adolescents",
keywords="rural",
keywords="African American",
keywords="implementation science",
abstract="Background: African American youth in rural Alabama are clinically underserved and have limited knowledge about the human papillomavirus and the novel coronavirus 2019 (COVID-19) vaccines, including knowledge about the risk for developing cervical or oropharyngeal cancers or COVID-19. Objective: In this 30-month study, we propose to develop an in-clinic, youth-tailored, vaccine-promoting intervention for vaccine hesitancy reduction that can be seamlessly integrated into the existing environments of pediatric and family practice settings in rural Alabama. Methods: This exploratory, sequential mixed methods study will be conducted in 3 phases. In the first phase, we will assess stakeholders' knowledge, sentiments, and beliefs related to vaccination in general, COVID-19 vaccination, and human papillomavirus vaccination. We will also assess stakeholders' perceptions of barriers to vaccination that exist in rural Alabama. This will be followed by a second phase wherein we will use the data collected in the first phase to inform the development and finalization of a noninvasive, modular, synchronous counseling intervention that targets the behaviors of 15- to 26-year-old adolescents. In the third phase, we will conduct a pilot hybrid type 1 effectiveness-implementation cluster-randomized controlled trial to assess intervention acceptability and feasibility (clinics: N=4; African American youth: N=120) while assessing a ``clinical signal'' of effectiveness. We will document implementation contexts to provide real-world insight and support dissemination and scale-up. Results: The study was funded at the end of December 2020. Approval from the University of Alabama at Birmingham Institutional Review Board was obtained in May 2021, and the qualitative data collection process outlined in the first phase of this project concluded in November 2021. The entire study is expected to be complete at the end of December 2023. Conclusions: The results of the trial will provide much needed information on vaccine hesitancy in rural Alabama, and if found efficacious, the intervention could notably increase rates of vaccinations in one of the most underserved parts of the United States. The results from the trial will provide information that is valuable to public health practitioners and providers in rural settings to inform their efforts in increasing vaccination rates among 15- to 26-year-old African American youth in rural southern United States. Trial Registration: ClinicalTrials.gov NCT04604743; https://clinicaltrials.gov/ct2/show/NCT04604743 International Registered Report Identifier (IRRID): DERR1-10.2196/33982 ",
doi="10.2196/33982",
url="https://www.researchprotocols.org/2022/4/e33982",
url="http://www.ncbi.nlm.nih.gov/pubmed/35212640"
}


@Article{info:doi/10.2196/32338,
author="Lok, YW Kris
and Ko, WT Rachel
and Fan, SL Heidi
and Chau, PH
and Wong, YH Janet
and Wang, MP
and Tsang, Vicky",
title="Feasibility and Acceptability of an Online WhatsApp Support Group on Breastfeeding: Protocol for a Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2022",
month="Mar",
day="9",
volume="11",
number="3",
pages="e32338",
keywords="mHealth",
keywords="breastfeeding",
keywords="peer support",
keywords="mobile health",
keywords="parenting",
keywords="instant messaging",
keywords="online support",
keywords="women's health",
keywords="postpartum health",
keywords="postpartum support",
abstract="Background: Mobile health, the use of mobile technology in delivering health care, has been found to be effective in changing health behaviors, including improving breastfeeding practices in postpartum women. With the widespread use of smartphones and instant messaging apps in Hong Kong, instant messaging groups could be a useful channel for delivering breastfeeding peer support. Objective: The aim of this paper is to study the feasibility and acceptability of an online instant messaging peer support group by trained peer counselors on improving breastfeeding outcome in primiparous women in Hong Kong. Methods: A two-arm, assessor-blind, randomized controlled feasibility study will be conducted on 40 primiparous women with the intention to breastfeed. Participants are recruited from the antenatal obstetrics and gynecology clinic of a public hospital in Hong Kong and randomly assigned at a 1:1 ratio to either intervention or control group. The intervention group receives peer support in an online instant messaging group with trained peer counselors on top of standard care, whereas the control group receives standard care. Breastfeeding outcome will be assessed for 6 months post partum or until weaned. The breastfeeding status, the proportion and duration of exclusive and any breastfeeding in each group, and the self-efficacy and attitude of participants will be assessed. The feasibility and acceptability of the study would also be assessed in preparation for a full randomized controlled trial. Results: This study (protocol version 1 dated January 5, 2021) has been reviewed and approved by the institutional review board of the University of Hong Kong, Hospital Authority Hong Kong West Cluster (reference UW 21-039), on January 26, 2021. Data collection is ongoing and expected to be completed in December 2021. The findings will be updated on clinical trial registry and disseminated in peer-reviewed journals. Conclusions: This study aims to assess the feasibility and effectiveness of an online instant messaging peer support group in improving the breastfeeding outcome of primiparous women in Hong Kong. Its findings could inform the feasibility of a full-scale trial with this intervention design. Trial Registration: ClinicalTrials.gov NCT04826796; https://clinicaltrials.gov/ct2/show/NCT04826796 International Registered Report Identifier (IRRID): DERR1-10.2196/32338 ",
doi="10.2196/32338",
url="https://www.researchprotocols.org/2022/3/e32338",
url="http://www.ncbi.nlm.nih.gov/pubmed/35262504"
}


@Article{info:doi/10.2196/34778,
author="Wong, Cheong Kam
and Nguyen, N. Tu
and Marschner, Simone
and Turnbull, Samual
and Burns, Jenner Mason
and Ne, Anna Jia Yi
and Gopal, Vishal
and Indrawansa, Balasuriya Anupama
and Trankle, A. Steven
and Usherwood, Tim
and Kumar, Saurabh
and Lindley, I. Richard
and Chow, K. Clara",
title="Patient-Led Mass Screening for Atrial Fibrillation in the Older Population Using Handheld Electrocardiographic Devices Integrated With a Clinician-Coordinated Remote Central Monitoring System: Protocol for a Randomized Controlled Trial and Process Evaluation",
journal="JMIR Res Protoc",
year="2022",
month="Feb",
day="1",
volume="11",
number="2",
pages="e34778",
keywords="atrial fibrillation",
keywords="screening",
keywords="handheld",
keywords="electrocardiogram",
keywords="ECG",
keywords="acceptability",
keywords="user perception",
keywords="user experience",
keywords="barrier",
keywords="enabler",
keywords="older adults",
keywords="elderly",
keywords="feasibility",
keywords="effectiveness",
keywords="implementation",
keywords="monitoring",
keywords="aging",
keywords="cardiovascular",
keywords="cardiology",
keywords="heart disease",
keywords="mobile phone",
abstract="Background: Atrial fibrillation (AF) is common in older people and increases the risk of stroke. The feasibility and effectiveness of the implementation of a patient-led AF screening program for older people are unknown. Objective: This study aims to examine the feasibility and effectiveness of an AF screening program comprising patient-led monitoring of single-lead electrocardiograms (ECGs) with clinician-coordinated central monitoring to diagnose AF among community-dwelling people aged ?75 years in Australia. Methods: This is a nationwide randomized controlled implementation trial conducted via the internet and remotely among 200 community-dwelling adults aged ?75 years with no known AF. Randomization will be performed in a 1:1 allocation ratio for the intervention versus control. Intervention group participants will be enrolled in the monitoring program at randomization. They will receive a handheld single-lead ECG device and training on the self-recording of ECGs on weekdays and submit their ECGs via their smartphones. The control group participants will receive usual care from their general practitioners for the initial 6 months and then commence the 6-month monitoring program. The ECGs will be reviewed centrally by trained personnel. Participants and their general practitioners will be notified of AF and other clinically significant ECG abnormalities. Results: This study will establish the feasibility and effectiveness of implementing the intervention in this patient population. The primary clinical outcome is the AF detection rate, and the primary feasibility outcome is the patient satisfaction score. Other outcomes include appropriate use of anticoagulant therapy, participant recruitment rate, program engagement (eg, frequency of ECG transmission), agreement in ECG interpretation between the device automatic algorithm and clinicians, the proportion of participants who complete the trial and number of dropouts, and the impact of frailty on feasibility and outcomes. We will conduct a qualitative evaluation to examine the barriers to and acceptability and enablers of implementation. Ethics approval was obtained from the human research ethics committee at the University of Sydney (project number 2020/680). The results will be disseminated via conventional scienti?c forums, including peer-reviewed publications and presentations at national and international conferences. Conclusions: By incorporating an integrated health care approach involving patient empowerment, centralized clinician-coordinated ECG monitoring, and facilitation of primary care and specialist services, it is possible to diagnose and treat AF early to reduce stroke risk. This study will provide new information on how to implement AF screening using digital health technology practicably and feasibly for older and frail populations residing in the community. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12621000184875; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380877 International Registered Report Identifier (IRRID): DERR1-10.2196/34778 ",
doi="10.2196/34778",
url="https://www.researchprotocols.org/2022/2/e34778",
url="http://www.ncbi.nlm.nih.gov/pubmed/35103614"
}


@Article{info:doi/10.2196/26717,
author="Valk, Anne Heather
and Garcia-Ochoa, Carlos
and Fontaine Calder, Jessica
and Miller, Toba
and Rashidi, Babak
and McIsaac, Corrine
and Musselman, Reilly",
title="A Mobile App for Wound and Symptom Surveillance After Colorectal Surgery: Protocol for a Feasibility Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2022",
month="Jan",
day="14",
volume="11",
number="1",
pages="e26717",
keywords="eHealth",
keywords="mobile app",
keywords="surgical site infection",
keywords="colorectal surgery",
keywords="app",
keywords="surgery",
keywords="infection",
keywords="wound",
keywords="surveillance",
keywords="feasibility",
keywords="randomized controlled trial",
keywords="tracking",
keywords="patient experience",
keywords="COVID-19",
keywords="transmission",
abstract="Background: Surgical site infections (SSIs) are the most common nosocomial infection and occur in 16.3\% of patients undergoing colorectal surgery at our institution (The Ottawa Hospital), the majority of which are identified after discharge from hospital. Patients who suspect having an SSI generally present to the emergency department or surgery clinic. Both options for in-person interaction are costly to the health care system and patients. A mobile app, how2trak, has proven to be beneficial for patients with complex wounds at our institution by facilitating at-home monitoring and virtual consultations. Objective: This study aims to assess the feasibility of a randomized controlled trial to assess if how2trak can improve patients' experience and increase detection of SSIs after colorectal surgery while reducing patients' risk of COVID-19 exposure. Methods: In this single-center prospective feasibility trial, eligible patients undergoing colorectal surgery will be randomized to either standard care or how2trak postoperative monitoring of their incision, symptoms, and ostomy function. Patient self-assessments will be monitored by a nurse specialized in wound and ostomy care who will follow-up with patients with a suspected SSI. The primary outcome is feasibility as measured by enrollment, randomization, app usability, data extraction, and resource capacity. Results: This study was approved by our institution's ethics board on February 26, 2021, and received support from The Ottawa Hospital Innovation and Care Funding on November 12, 2021. Recruitment started June 3, 2021, and 29 were patients enrolled as of September 2021. We expect to publish results in spring 2022. Conclusions: This study will determine the feasibility of using a mobile app to monitor patients' wounds and detect SSIs after colorectal surgery. If feasible, we plan to assess if this mobile app facilitates SSI detection, enhances patient experience, and optimizes their care. Trial Registration: ClinicalTrials.gov NCT04869774; https://clinicaltrials.gov/ct2/show/NCT04869774 International Registered Report Identifier (IRRID): DERR1-10.2196/26717 ",
doi="10.2196/26717",
url="https://www.researchprotocols.org/2022/1/e26717",
url="http://www.ncbi.nlm.nih.gov/pubmed/34854816"
}


@Article{info:doi/10.2196/30339,
author="Gonsalves, P. Pattie
and Sharma, Rhea
and Hodgson, Eleanor
and Bhat, Bhargav
and Jambhale, Abhijeet
and Weiss, A. Helen
and Fairburn, G. Christopher
and Cavanagh, Kate
and Cuijpers, Pim
and Michelson, Daniel
and Patel, Vikram",
title="A Guided Internet-Based Problem-Solving Intervention Delivered Through Smartphones for Secondary School Pupils During the COVID-19 Pandemic in India: Protocol for a Pilot Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2021",
month="Oct",
day="6",
volume="10",
number="10",
pages="e30339",
keywords="randomized controlled trial",
keywords="internet-based intervention",
keywords="smartphone",
keywords="adolescent",
keywords="schools",
keywords="mental health",
keywords="COVID-19",
keywords="app",
keywords="protocol",
keywords="problem-solving",
keywords="intervention",
keywords="teenager",
keywords="young adult",
keywords="India",
keywords="feasibility",
keywords="effective",
abstract="Background: ``POD Adventures'' is a gamified mental health intervention delivered via a smartphone app and supported by counsellors for a target population of secondary school students in India. This paper describes the protocol for a pilot randomized controlled trial of a remotely delivered version of the intervention in the context of COVID-19 restrictions. Objective: Our objectives are to assess the feasibility of research procedures and intervention delivery and to generate preliminary estimates of the effectiveness of the intervention to inform the sample size calculation of a full-scale trial. Methods: We will conduct a parallel, 2-arm, individually randomized pilot controlled trial in 11 secondary schools in Goa, India. This pilot trial aims to recruit 70 participants with a felt need for psychological support. Participants will receive either the POD Adventures intervention delivered over 4 weeks or usual care comprising information about local mental health services and national helplines. Outcomes will be assessed at two timepoints: baseline and 6 weeks post randomization. Results: The first participant was enrolled on January 28, 2021, and 6-week assessment completed on April 4, 2021. Owing to a second wave of the COVID-19 pandemic in India, schools in Goa were closed on April 22, 2021. Trial participants are currently receiving the intervention or completing follow-up assessments. Conclusions: This pilot trial will help understand the feasibility of implementing and evaluating a remotely delivered digital mental health intervention in a low-resource setting. Our findings will be used to design future trials that can address difficulties of accessing psychosocial support in-person and support wider efforts to scale up evidence-based mental health interventions for young people. Trial Registration: ClinicalTrials.gov NCT04672486; https://clinicaltrials.gov/ct2/show/NCT04672486 International Registered Report Identifier (IRRID): DERR1-10.2196/30339 ",
doi="10.2196/30339",
url="https://www.researchprotocols.org/2021/10/e30339",
url="http://www.ncbi.nlm.nih.gov/pubmed/34586075"
}


@Article{info:doi/10.2196/19232,
author="Damery, Sarah
and Jones, Janet
and O'Connell Francischetto, Elaine
and Jolly, Kate
and Lilford, Richard
and Ferguson, James",
title="Remote Consultations Versus Standard Face-to-Face Appointments for Liver Transplant Patients in Routine Hospital Care: Feasibility Randomized Controlled Trial of myVideoClinic",
journal="J Med Internet Res",
year="2021",
month="Sep",
day="17",
volume="23",
number="9",
pages="e19232",
keywords="digital health",
keywords="remote consultation",
keywords="patient satisfaction",
keywords="feasibility",
keywords="VSQ-9",
keywords="secondary care",
keywords="liver transplant patients",
keywords="mobile phone",
abstract="Background: Using technology to reduce the pressure on the National Health Service (NHS) in England and Wales is a key government target, and the NHS Long-Term Plan outlines a strategy for digitally enabled outpatient care to become mainstream by 2024. In 2020, the COVID-19 response saw the widespread introduction of remote consultations for patient follow-up, regardless of individual preferences. Despite this rapid change, there may be enduring barriers to the effective implementation of remote appointments into routine practice once the unique drivers for change during the COVID-19 pandemic no longer apply, to which pre-COVID implementation studies can offer important insights. Objective: This study aims to evaluate the feasibility of using real-time remote consultations between patients and secondary care physicians for routine patient follow-up at a large hospital in the United Kingdom and to assess whether patient satisfaction differs between intervention and usual care patients. Methods: Clinically stable liver transplant patients were randomized to real-time remote consultations in which their hospital physician used secure videoconferencing software (intervention) or standard face-to-face appointments (usual care). Participants were asked to complete postappointment questionnaires over 12 months. Data were analyzed on an intention-to-treat basis. The primary outcome was the difference in scores between baseline and study end by patient group for the three domains of patient satisfaction (assessed using the Visit-Specific Satisfaction Instrument). An embedded qualitative process evaluation used interviews to assess patient and staff experiences. Results: Of the 54 patients who were randomized, 29 (54\%) received remote consultations, and 25 (46\%) received usual care (recruitment rate: 54/203, 26.6\%). The crossover between study arms was high (13/29, 45\%). A total of 129 appointments were completed, with 63.6\% (82/129) of the questionnaires being returned. Patient satisfaction at 12 months increased in both the intervention (25 points) and usual care (14 points) groups. The within-group analysis showed that the increases were significant for both intervention (P<.001) and usual care (P=.02) patients; however, the between-group difference was not significant after controlling for baseline scores (P=.10). The qualitative process evaluation showed that---according to patients---remote consultations saved time and money, were less burdensome, and caused fewer negative impacts on health. Technical problems with the software were common, and only 17\% (5/29) of patients received all appointments over video. Both consultants and patients saw remote consultations as positive and beneficial. Conclusions: Using technology to conduct routine follow-up appointments remotely may ease some of the resource and infrastructure challenges faced by the UK NHS and free up clinic space for patients who must be seen face-to-face. Our findings regarding the advantages and challenges of using remote consultations for routine follow-ups of liver transplant patients have important implications for service organization and delivery in the postpandemic NHS. Trial Registration: ISRCTN Registry 14093266; https://www.isrctn.com/ISRCTN14093266 International Registered Report Identifier (IRRID): RR2-10.1186/s13063-018-2953-4 ",
doi="10.2196/19232",
url="https://www.jmir.org/2021/9/e19232",
url="http://www.ncbi.nlm.nih.gov/pubmed/34533461"
}


@Article{info:doi/10.2196/26054,
author="Wyse, Rebecca
and Delaney, Tessa
and Stacey, Fiona
and Zoetemeyer, Rachel
and Lecathelinais, Christophe
and Lamont, Hannah
and Ball, Kylie
and Campbell, Karen
and Rissel, Chris
and Attia, John
and Wiggers, John
and Yoong, Lin Sze
and Oldmeadow, Christopher
and Sutherland, Rachel
and Nathan, Nicole
and Reilly, Kathryn
and Wolfenden, Luke",
title="Effectiveness of a Multistrategy Behavioral Intervention to Increase the Nutritional Quality of Primary School Students' Web-Based Canteen Lunch Orders (Click \& Crunch): Cluster Randomized Controlled Trial",
journal="J Med Internet Res",
year="2021",
month="Sep",
day="7",
volume="23",
number="9",
pages="e26054",
keywords="nudge",
keywords="choice architecture",
keywords="intervention",
keywords="online canteen",
keywords="online ordering systems",
keywords="digital interventions",
keywords="school children",
keywords="school food service",
keywords="canteens",
keywords="menu labeling",
abstract="Background: School food outlets represent a key setting for public health nutrition intervention. The recent proliferation of web-based food ordering systems provides a unique opportunity to support healthy purchasing from schools. Embedding evidence-based choice architecture strategies within these routinely used systems provides the opportunity to impact the purchasing decisions of many users simultaneously and warrants investigation. Objective: This study aims to assess the effectiveness of a multistrategy behavioral intervention implemented via a web-based school canteen lunch ordering system in reducing the energy, saturated fat, sugar, and sodium content of primary students' web-based lunch orders. Methods: The study used a parallel-group, cohort, cluster randomized controlled trial design with 2207 students from 17 Australian primary schools. Schools with a web-based canteen lunch ordering system were randomly assigned to receive either a multistrategy behavioral intervention that included choice architecture strategies embedded in the web-based system (n=9 schools) or the standard web-based ordering system only (n=8 control schools). Automatically collected student purchasing data at baseline (term 2, 2018) and 12 months later (term 2, 2019) were used to assess trial outcomes. Primary trial outcomes included the mean energy (kJ), saturated fat (g), sugar (g), and sodium (mg) content of student lunch orders. Secondary outcomes included the proportion of all web-based lunch order items classified as everyday, occasional, and caution (based on the New South Wales Healthy School Canteen Strategy) and canteen revenue. Results: From baseline to follow-up, the intervention lunch orders had significantly lower energy content (?69.4 kJ, 95\% CI ?119.6 to ?19.1; P=.01) and saturated fat content (?0.6 g, 95\% CI ?0.9 to ?0.4; P<.001) than the control lunch orders, but they did not have significantly lower sugar or sodium content. There was also a small significant between-group difference in the percentage of energy from saturated fat (?0.9\%, 95\% CI ?1.4\% to ?0.5\%; P<.001) but not in the percentage of energy from sugar (+1.1\%, 95\% CI 0.2\% to 1.9\%; P=.02). Relative to control schools, intervention schools had significantly greater odds of having everyday items purchased (odds ratio [OR] 1.7, 95\% CI 1.5-2.0; P<.001), corresponding to a 9.8\% increase in everyday items, and lower odds of having occasional items purchased (OR 0.7, 95\% CI 0.6-0.8; P<.001), corresponding to a 7.7\% decrease in occasional items); however, there was no change in the odds of having caution (least healthy) items purchased (OR 0.8, 95\% CI 0.7-1.0; P=.05). Furthermore, there was no change in schools' revenue between groups. Conclusions: Given the evidence of small statistically significant improvements in the energy and saturated fat content, acceptability, and wide reach, this intervention has the potential to influence dietary choices at a population level, and further research is warranted to determine its impact when implemented at scale. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12618000855224; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375075. International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2019-030538 ",
doi="10.2196/26054",
url="https://www.jmir.org/2021/9/e26054",
url="http://www.ncbi.nlm.nih.gov/pubmed/34491207"
}


@Article{info:doi/10.2196/21116,
author="McDiarmid, Sarah
and Harvie, Michelle
and Johnson, Rhona
and Vyas, Avni
and Aglan, Azza
and Moran, Jacqui
and Ruane, Helen
and Hulme, Amanda
and Sellers, Katharine
and Issa, Basil",
title="Intermittent Versus Continuous Low-Energy Diet in Patients With Type 2 Diabetes: Protocol for a Pilot Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2021",
month="Mar",
day="19",
volume="10",
number="3",
pages="e21116",
keywords="type 2 diabetes",
keywords="diabetes",
keywords="diabetic diet",
keywords="low-energy diet",
keywords="low calorie diet",
keywords="intermittent energy restriction",
keywords="intermittent fasting",
keywords="diabetes remission",
keywords="smartphone",
keywords="mobile phone",
keywords="mHealth",
keywords="mobile health",
abstract="Background: Intensive face-to-face weight loss programs using continuous low-energy diets (CLEDs) providing approximately 800 kcal per day (3347 kJ per day) can produce significant weight loss and remission from type 2 diabetes (T2D). Intermittent low-energy diets (ILEDs) and remotely delivered programs could be viable alternatives that may support patient choice and adherence. Objective: This paper describes the protocol of a pilot randomized controlled trial to test the feasibility and potential efficacy of remotely supported isocaloric ILED and CLED programs among patients with overweight and obesity and T2D. Methods: A total of 79 participants were recruited from primary care, two National Health Service hospital trusts, and a voluntary T2D research register in the United Kingdom. The participants were randomized to a remotely delivered ILED (n=39) or CLED (n=40). The active weight loss phase of CLED involved 8 weeks of Optifast 820 kcal/3430 kJ formula diet, followed by 4 weeks of food reintroduction. The active weight loss phase of ILED (n=39) comprised 2 days of Optifast 820 kcal/3430 kJ diet and 5 days of a portion-controlled Mediterranean diet for 28 weeks. Both groups were asked to complete 56 Optifast 820 kcal/3430 kJ days during their active weight loss phase with an equivalent energy deficit. The diets were isocaloric for the remainder of the 12 months. CLED participants were asked to follow a portion-controlled Mediterranean diet 7 days per week. ILED followed 1-2 days per week of a food-based 820 kcal/3430 kJ diet and a portion-controlled Mediterranean diet for 5-6 days per week. Participants received high-frequency (weekly, fortnightly, or monthly depending on the stage of the trial) multidisciplinary remote support from a dietitian, nurse, exercise specialist, and psychologist via telephone or the Oviva smartphone app. The primary outcomes of the study were uptake, weight loss, and changes in glycated hemoglobin at 12 months. An outcome assessment of trial retention was retrospectively added. Secondary outcomes included an assessment of adherence and adverse events. A qualitative evaluation was undertaken via interviews with participants and health care professionals who delivered the intervention. Results: A total of 79 overweight or obese participants aged 18-75 years and diagnosed with T2D in the last 8 years were recruited to the Manchester Intermittent and Daily Diet Diabetes App Study (MIDDAS). Recruitment began in February 2018, and data collection was completed in February 2020. Data analysis began in June 2020, and the first results are expected to be submitted for publication in 2021. Conclusions: The outcomes of the MIDDAS study will inform the feasibility of remotely delivered ILED and CLED programs in clinical practice and the requirement for a larger-scale randomized controlled trial. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN) 15394285; http://www.isrctn.com/ISRCTN15394285 International Registered Report Identifier (IRRID): DERR1-10.2196/21116 ",
doi="10.2196/21116",
url="https://www.researchprotocols.org/2021/3/e21116",
url="http://www.ncbi.nlm.nih.gov/pubmed/33739297"
}


@Article{info:doi/10.2196/22500,
author="Pelletier, Jean-Francois
and Houle, Janie
and Goulet, Marie-H{\'e}l{\`e}ne
and Juster, Robert-Paul
and Gigu{\`e}re, Charles-{\'E}douard
and Bordet, Jonathan
and H{\'e}nault, Isabelle
and Lesage, Alain
and De Benedictis, Luigi
and Denis, Fr{\'e}d{\'e}ric
and Ng, Roger",
title="Online and Recovery-Oriented Support Groups Facilitated by Peer Support Workers in Times of COVID-19: Protocol for a Feasibility Pre-Post Study",
journal="JMIR Res Protoc",
year="2020",
month="Dec",
day="18",
volume="9",
number="12",
pages="e22500",
keywords="peer support workers",
keywords="internet-based peer support groups",
keywords="personal-civic recovery",
keywords="clinical recovery",
keywords="COVID-19 Stress Scales",
keywords="peer support",
keywords="feasibility",
keywords="mental health",
keywords="COVID-19",
keywords="intervention",
keywords="recovery",
abstract="Background: In times of pandemics, social distancing, isolation, and quarantine have precipitated depression, anxiety, and substance misuse. Scientific literature suggests that patients living with mental health problems or illnesses (MHPIs) who interact with peer support workers (PSWs) experience not only the empathy and connectedness that comes from similar life experiences but also feel hope in the possibility of recovery. So far, it is the effect of mental health teams or programs with PSWs that has been evaluated. Objective: This paper presents the protocol for a web-based intervention facilitated by PSWs. The five principal research questions are whether this intervention will have an impact in terms of (Q1) personal-civic recovery and (Q2) clinical recovery, (Q3) how these recovery potentials can be impacted by the COVID-19 pandemic, (Q4) how the lived experience of persons in recovery can be mobilized to cope with such a situation, and (Q5) how sex and gender considerations can be taken into account for the pairing of PSWs with service users beyond considerations based solely on psychiatric diagnoses or specific MHPIs. This will help us assess the impact of PSWs in this setting. Methods: PSWs will lead a typical informal peer support group within the larger context of online peer support groups, focusing on personal-civic recovery. They will be scripted with a fixed, predetermined duration (a series of 10 weekly 90-minute online workshops). There will be 2 experimental subgroups---patients diagnosed with (1) psychotic disorders (n=10) and (2) anxiety or mood disorders (n=10)---compared to a control group (n=10). Random assignment to the intervention and control arms will be conducted using a 2:1 ratio. Several instruments will be used to assess clinical recovery (eg, the Recovery Assessment Scale, the Citizenship Measure questionnaire). The COVID-19 Stress Scales will be used to assess effects in terms of clinical recovery and stress- or anxiety-related responses to COVID-19. Changes will be compared between groups from baseline to endpoint in the intervention and control groups using the Student paired sample t test. Results: This pilot study was funded in March 2020. The protocol was approved on June 16, 2020, by the Research Ethics Committees of the Montreal Mental Health University Institute. Recruitment took place during the months of July and August, and results are expected in December 2020. Conclusions: Study results will provide reliable evidence on the effectiveness of a web-based intervention provided by PSWs. The investigators, alongside key decision makers and patient partners, will ensure knowledge translation throughout, and our massive open online course (MOOC), The Fundamentals of Recovery, will be updated with the evidence and new knowledge generated by this feasibility study. Trial Registration: ClinicalTrials.gov NCT04445324; https://clinicaltrials.gov/ct2/show/NCT04445324 International Registered Report Identifier (IRRID): PRR1-10.2196/22500 ",
doi="10.2196/22500",
url="http://www.researchprotocols.org/2020/12/e22500/",
url="http://www.ncbi.nlm.nih.gov/pubmed/33259326"
}


@Article{info:doi/10.2196/21693,
author="Sprave, Tanja
and Z{\"o}ller, Daniela
and Stoian, Raluca
and R{\"u}hle, Alexander
and Kalckreuth, Tobias
and Haehl, Erik
and Fahrner, Harald
and Binder, Harald
and Grosu, Anca-Ligia
and Heinemann, Felix
and Nicolay, Henrik Nils",
title="App-Controlled Treatment Monitoring and Support for Head and Neck Cancer Patients (APCOT): Protocol for a Prospective Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2020",
month="Dec",
day="9",
volume="9",
number="12",
pages="e21693",
keywords="mHealth",
keywords="head and neck cancer",
keywords="HNSCC",
keywords="radiotherapy",
keywords="mobile app",
keywords="quality of life",
keywords="patient-reported outcome measures",
abstract="Background: Head and neck cancers (HNCs) are among the most common malignancies, which often require multimodal treatment that includes radiation therapy and chemotherapy. Patients with HNC have a high burden of symptoms due to both the damaging effects of the tumor and the aggressive multimodal treatment. Close symptom monitoring over the course of the disease may help to identify patients in need of medical interventions. Objective: This APCOT (App-Controlled Treatment Monitoring and Support for Head and Neck Cancer Patients) trial is designed to assess the feasibility of monitoring HNC patients during the course of (chemo)radiation therapy daily using a mobile app. Additionally, symptom patterns, patient satisfaction, and quality of life will be measured in app-monitored patients in comparison to a patient cohort receiving standard-of-care physician appointments, and health economy aspects of app monitoring will be analyzed. Methods: This prospective randomized single-center trial will evaluate the feasibility of integrating electronic patient-reported outcome measures (ePROMs) into the treatment workflow of HNC patients. Patients undergoing definitive or adjuvant (chemo)radiation therapy as part of their HNC treatment at the Department of Radiation Oncology, University Medical Center Freiburg (Freiburg, Germany) will receive weekly physician appointments and additional appointments as requested to monitor and potentially treat symptoms during the course of treatment. Patients in the experimental arm will additionally be monitored daily using a dedicated app regarding their disease- and treatment-related symptoms, quality of life, and need for personal physician appointments. The feasibility of ePROM monitoring will be tested as the primary endpoint and will be defined if ?80\% of enrolled patients have answered ?80\% of their daily app-based questions. Quality of life will be assessed using the validated European Organisation for Research and Treatment of Cancer questionnaires, and patient satisfaction will be measured by the validated Patient Satisfaction Questionnaire Short Form at the initiation, in the middle, and at completion of radiation therapy, as well as at follow-up examinations. Additionally, the number and duration of physician appointments during the course of radiation therapy will be quantified for both ePROM-monitored and standard-of-care patients. Results: This trial will enroll 100 patients who will be randomized (1:1) between the experimental arm with ePROM monitoring and the control arm with standard patient care. Recruitment will take 18 months, and trial completion is planned at 24 months after enrollment of the last patient. Conclusions: This trial will establish the feasibility of close ePROM monitoring of HNC patients undergoing (chemo)radiation therapy. The results can form the basis for further trials investigating potential clinical benefits of detailed symptom monitoring and patient-centered care in HNC patients regarding oncologic outcomes and quality of life. Trial Registration: German Clinical Trials Register DRKS00020491; https://www.drks.de/drks\_web/navigate.do?navigationId=trial.HTML\&TRIAL\_ID=DRKS00020491 International Registered Report Identifier (IRRID): PRR1-10.2196/21693 ",
doi="10.2196/21693",
url="https://www.researchprotocols.org/2020/12/e21693",
url="http://www.ncbi.nlm.nih.gov/pubmed/33295291"
}


@Article{info:doi/10.2196/23414,
author="Kapoor, Akshat
and Nambisan, Priya",
title="Exploring Interactive Survivorship Care Plans to Support Breast Cancer Survivors: Protocol for a Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2020",
month="Dec",
day="4",
volume="9",
number="12",
pages="e23414",
keywords="breast cancer",
keywords="cancer survivorship",
keywords="self-management",
keywords="patient education",
abstract="Background: Breast cancer is the most common form of cancer among American women, accounting for 23\% of all cancer survivors nationally. Yet, the availability of adequate resources and tools for supporting breast cancer survivors has not kept up with the rapid advancement in treatment options, resulting in unmet supportive care needs, particularly among low-income and minority populations. This study explores an alternative means of delivering breast cancer survivorship care plans (SCPs), with the aim of improving survivor morbidity, patient knowledge, and self-management of treatment-related symptoms, as well as addressing inconsistencies in follow-up care visits. Objective: The overall goal of this study is to improve the uptake of SCP recommendations via an educational intervention for breast cancer survivors, to improve treatment-related morbidity, patient knowledge, self-management, and adherence to follow-up visits. The specific aims of the study are to (1) evaluate the feasibility of the online SCP, and (2) assess the impact of the online SCP on survivorship outcomes. Methods: We will enroll 50 breast cancer survivors who have completed initial breast cancer treatment into a 2-armed, randomized, waitlist-controlled pilot trial, and collect data at baseline and 6 months. For the first aim, we will use mixed methods, including surveys and personal interviews among the intervention group, to determine the feasibility of providing an online, interactive SCP (called ACESO) based on the survivors' online user experience and their short-term adoption. For the secondary aim, we will compare the 2 groups to assess the primary outcomes of survivor knowledge, self-efficacy for self-management, perceived peer support, and adherence to SCP-recommended posttreatment follow-up visits to oncology and primary care; and the secondary outcomes of treatment-related morbidity (body weight, fatigue, depression, anxiety, sexual function, distress, and sleep quality). We assess these outcomes by using measurements from validated instruments with robust psychometric properties. Results: We have developed and refined the online breast cancer survivorship plan, ACESO, with consultation from breast cancer oncologists, nurses, and survivors. Approval for the study protocol has been obtained from the Institutional Review Board. An advisory board has also been established to provide oversight and recommendations on the conduct of the study. The study will be completed over a period of 2 years. Conclusions: The results of this pilot study will inform the feasibility and design of a larger-scale pragmatic trial to evaluate the impact of an online breast cancer SCP on treatment-related morbidity and self-efficacy for self-management. International Registered Report Identifier (IRRID): PRR1-10.2196/23414 ",
doi="10.2196/23414",
url="https://www.researchprotocols.org/2020/12/e23414",
url="http://www.ncbi.nlm.nih.gov/pubmed/33274725"
}


@Article{info:doi/10.2196/18522,
author="Fisher, Dominic
and Louw, Quinette
and Thabane, Lehana",
title="Sedentariness and Back Health in Western Cape Primary School Students: Protocol for a Pragmatic Stepped-Wedge Feasibility Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2020",
month="Nov",
day="30",
volume="9",
number="11",
pages="e18522",
keywords="sitting",
keywords="standing",
keywords="postural dynamism",
keywords="sit-stand desks",
keywords="classroom",
keywords="school",
keywords="sedentary",
keywords="children",
abstract="Background: Despite growing evidence of deleterious health outcomes associated with sedentary behavior, prolonged static sitting in classrooms remains ubiquitous in primary schools. Sedentary behavior is associated with the development of cardio-metabolic conditions and poor back health. Preventative strategies to reduce sedentary behavior and its negative health effects may be required in a resource-constrained environment such as South Africa. Objective: The primary objective of this study is to assess the feasibility of conducting a full trial to evaluate the effects of a multifaceted intervention comprising novel multifunctional classroom furniture and a video-based curriculum versus usual care on sedentary behavior among students aged 10-11 years in primary schools. The secondary objective is to assess the preliminary effects of the intervention on sedentary behavior and postural dynamism. Methods: Eighty grade 5 or 6 students, aged 10 and 11 years, in mixed-gender schools within the Western Cape metropolitan urban area in Cape Town, South Africa are eligible to participate in this  pilot cluster stepped-wedge trial design with classroom as the unit of randomization. Data will be collected at the schools. The intervention will comprise multifunctional classroom furniture that allows for sitting and standing as well as a video-based curriculum on sedentary behavior. Usual practice is the absence of the intervention. The primary outcomes assessed will be (1) adherence to the intervention and (2) project pragmatics. The secondary outcomes will be (1) sedentariness measured using activPAL3 microsensors and (2) postural dynamism measured using Noraxon Myomotion inertial measurement units. We randomized the school to the first or second start of the intervention. This is an open-label trial and therefore blinding will not be possible for any group. Descriptive analysis of the feasibility and physiological outcomes will be presented. We will report the preliminary estimates of the effects of the intervention on sedentariness and postural dynamism using the mean difference and 95\% CI. Results: At the time of submission, two classrooms have been recruited into the study. Baseline physical activity and postural dynamism data have been collected from 10 participants from each class. Conclusions: The results of this feasibility stepped-wedge cluster randomized controlled trial will be useful in informing the design of the main trial to assess whether this multifaceted intervention of multifunctional classroom furniture that allows for sitting and standing as well as a video-based curriculum versus usual care has any effect on sedentary behavior in low-resource-setting primary schools. Trial Registration: Pan African Trials Registry PACTR201811799476016; https://tinyurl.com/y4upoys8 International Registered Report Identifier (IRRID): RR1-10.2196/18522 ",
doi="10.2196/18522",
url="http://www.researchprotocols.org/2020/11/e18522/",
url="http://www.ncbi.nlm.nih.gov/pubmed/33089783"
}


@Article{info:doi/10.2196/14322,
author="Gonze, Barros B{\'a}rbara De
and Padovani, Costa Ricardo Da
and Simoes, Socorro Maria Do
and Lauria, Vinicius
and Proen{\c{c}}a, Leite Neli
and Sperandio, Fornias Evandro
and Ostolin, Paschoale Thatiane Lopes Valentim Di
and Gomes, Oliveira Grace Ang{\'e}lica De
and Castro, Costa Paula
and Romiti, Marcello
and Gagliardi, Antonio
and Arantes, Leite Rodolfo
and Dourado, Zuniga Victor",
title="Use of a Smartphone App to Increase Physical Activity Levels in Insufficiently Active Adults: Feasibility Sequential Multiple Assignment Randomized Trial (SMART)",
journal="JMIR Res Protoc",
year="2020",
month="Oct",
day="23",
volume="9",
number="10",
pages="e14322",
keywords="tailored messages",
keywords="gamification",
keywords="steps per day",
abstract="Background: The sequential multiple assignment randomized trial (SMART) design allows for changes in the intervention during the trial period. Despite its potential and feasibility for defining the best sequence of interventions, so far, it has not been utilized in a smartphone/gamified intervention for physical activity. Objective: We aimed to investigate the feasibility of the SMART design for assessing the effects of a smartphone app intervention to improve physical activity in adults. We also aimed to describe the participants' perception regarding the protocol and the use of the app for physical activity qualitatively. Methods: We conducted a feasibility 24-week/two-stage SMART in which 18 insufficiently active participants (<10,000 steps/day) were first randomized to group 1 (smartphone app only), group 2 (smartphone app + tailored messages), and a control group (usual routine during the protocol). Participants were motivated to increase their step count by at least 2000 steps/day each week. Based on the 12-week intermediate outcome, responders continued the intervention and nonresponders were rerandomized to subsequent treatment, including a new group 3 (smartphone app + tailored messages + gamification) in which they were instructed to form groups to use several game elements available in the chosen app (Pacer). We considered responders as those with any positive slope in the linear relationship between weeks and steps per day at the end of the first stage of the intervention. We compared the accelerometer-based steps per day before and after the intervention, as well as the slopes of the app-based steps per day between the first and second stages of the intervention. Results: Twelve participants, including five controls, finished the intervention. We identified two responders in group 1. We did not observe relevant changes in the steps per day either throughout the intervention or compared with the control group. However, the rerandomization of five nonresponders led to a change in the slope of the steps per day (median ?198 steps/day [IQR ?279 to ?103] to 20 steps/day [IQR ?204 to 145]; P=.08). Finally, in three participants from group 2, we observed an increase in the number of steps per day up to the sixth week, followed by an inflection to baseline values or even lower (ie, a quadratic relationship). The qualitative analysis showed that participants' reports could be classified into the following: (1) difficulty in managing the app and technology or problems with the device, (2) suitable response to the app, and (3) difficulties to achieve the goals. Conclusions: The SMART design was feasible and changed the behavior of steps per day after rerandomization. Rerandomization should be implemented earlier to take advantage of tailored messages. Additionally, difficulties with technology and realistic and individualized goals should be considered in interventions for physical activity using smartphones. Trial Registration: Brazilian Registry of Clinical Trials RBR-8xtc9c; http://www.ensaiosclinicos.gov.br/rg/RBR-8xtc9c/. ",
doi="10.2196/14322",
url="https://www.researchprotocols.org/2020/10/e14322",
url="http://www.ncbi.nlm.nih.gov/pubmed/33094733"
}


@Article{info:doi/10.2196/18971,
author="Broome, Elizabeth Emma
and Coleston-Shields, Maria Donna
and Dening, Tom
and Moniz-Cook, Esme
and Poland, Fiona
and Stanyon, Miriam
and Orrell, Martin",
title="AQUEDUCT Intervention for Crisis Team Quality and Effectiveness in Dementia: Protocol for a Feasibility Study",
journal="JMIR Res Protoc",
year="2020",
month="Oct",
day="13",
volume="9",
number="10",
pages="e18971",
keywords="dementia",
keywords="crisis",
keywords="mental health",
keywords="community services",
keywords="feasibility study",
abstract="Background: Specialist community teams often support people with dementia who experience crisis. These teams may vary in composition and models of practice, which presents challenges when evaluating their effectiveness. A best practice model for dementia crisis services could be used by teams to improve the quality and effectiveness of the care they deliver. Objective: The aim of this study is to examine the feasibility of conducting a large-scale randomized controlled trial comparing the AQUEDUCT (Achieving Quality and Effectiveness in Dementia Using Crisis Teams) Resource Kit intervention to treatment as usual. Methods: This is a multisite feasibility study in preparation for a future randomized controlled trial. Up to 54 people with dementia (and their carers) and 40 practitioners will be recruited from 4 geographically widespread teams managing crisis in dementia. Quantitative outcomes will be recorded at baseline and at discharge. This study will also involve a nested health economic substudy and qualitative research to examine participant experiences of the intervention and acceptability of research procedures. Results: Ethical approval for this study was granted in July 2019. Participant recruitment began in September 2019, and as of September 2020, all data collection has been completed. Results of this study will establish the acceptability of the intervention, recruitment rates, and will assess the feasibility and appropriateness of the outcome measures in preparation for a large-scale randomized controlled trial. Conclusions: There is a need to evaluate the effectiveness of crisis intervention teams for older people with dementia. This is the first study to test the feasibility of an evidence-based best practice model for teams managing crisis in dementia. The results of this study will assist in the planning and delivery of a large-scale randomized controlled trial. International Registered Report Identifier (IRRID): DERR1-10.2196/18971 ",
doi="10.2196/18971",
url="http://www.researchprotocols.org/2020/10/e18971/",
url="http://www.ncbi.nlm.nih.gov/pubmed/33048059"
}


@Article{info:doi/10.2196/20501,
author="Sieverdes, C. John
and Treiber, A. Frank
and Kline, E. Christopher
and Mueller, Martina
and Brunner-Jackson, Brenda
and Sox, Luke
and Cain, Mercedes
and Swem, Maria
and Diaz, Vanessa
and Chandler, Jessica",
title="Ethnicity Differences in Sleep Changes Among Prehypertensive Adults Using a Smartphone Meditation App: Dose-Response Trial",
journal="JMIR Form Res",
year="2020",
month="Oct",
day="6",
volume="4",
number="10",
pages="e20501",
keywords="meditation",
keywords="sleep",
keywords="mobile phone",
keywords="prehypertension",
keywords="ethnicity",
abstract="Background: African Americans (AAs) experience greater sleep quality problems than non-Hispanic Whites (NHWs). Meditation may aid in addressing this disparity, although the dosage levels needed to achieve such benefits have not been adequately studied. Smartphone apps present a novel modality for delivering, monitoring, and measuring adherence to meditation protocols. Objective: This 6-month dose-response feasibility trial investigated the effects of a breathing awareness meditation (BAM) app, Tension Tamer, on the secondary outcomes of self-reported and actigraphy measures of sleep quality and the modulating effects of ethnicity of AAs and NHWs. Methods: A total of 64 prehypertensive adults (systolic blood pressure <139 mm Hg; 31 AAs and 33 NHWs) were randomized into 3 different Tension Tamer dosage conditions (5,10, or 15 min twice daily). Sleep quality was assessed at baseline and at 1, 3, and 6 months using the Pittsburgh Sleep Quality Index (PSQI) and 1-week bouts of continuous wrist actigraphy monitoring. The study was conducted between August 2014 and October 2016 (IRB \#Pro00020894). Results: At baseline, PSQI and actigraphy data indicated that AAs had shorter sleep duration, greater sleep disturbance, poorer efficiency, and worse quality of sleep (range P=.03 to P<.001). Longitudinal generalized linear mixed modeling revealed a dose effect modulated by ethnicity (P=.01). Multimethod assessment showed a consistent pattern of NHWs exhibiting the most favorable responses to the 5-min dose; they reported greater improvements in sleep efficiency and quality as well as the PSQI global value than with the 10-min and 15-min doses (range P=.04 to P<.001). Actigraphy findings revealed a consistent, but not statistically significant, pattern in the 5-min group, showing lower fragmentation, longer sleep duration, and higher efficiency than the other 2 dosage conditions. Among AAs, actigraphy indicated lower sleep fragmentation with the 5-min dose compared with the 10-min and 15-min doses (P=.03 and P<.001, respectively). The 10-min dose showed longer sleep duration than the 5-min and 15-min doses (P=.02 and P<.001, respectively). The 5-min dose also exhibited significantly longer average sleep than the 15-min dose (P=.03). Conclusions: These findings indicate the need for further study of the potential modulating influence of ethnicity on the impact of BAM on sleep indices and user-centered exploration to ascertain the potential merits of refining the Tension Tamer app with attention to cultural tailoring among AAs and NHWs with pre-existing sleep complaints. ",
doi="10.2196/20501",
url="https://formative.jmir.org/2020/10/e20501",
url="http://www.ncbi.nlm.nih.gov/pubmed/33021484"
}


@Article{info:doi/10.2196/16925,
author="Browne, Sarah
and Kechadi, M-Tahar
and O'Donnell, Shane
and Dow, Mckenzie
and Tully, Louise
and Doyle, Gerardine
and O'Malley, Grace",
title="Mobile Health Apps in Pediatric Obesity Treatment: Process Outcomes From a Feasibility Study of a Multicomponent Intervention",
journal="JMIR Mhealth Uhealth",
year="2020",
month="Jul",
day="8",
volume="8",
number="7",
pages="e16925",
keywords="childhood obesity",
keywords="diet therapy",
keywords="mHealth",
keywords="mobile phones",
keywords="smartphones",
keywords="appetite",
keywords="satiety",
keywords="rate of eating",
keywords="accelerometer",
keywords="physical activity",
abstract="Background: Multicomponent family interventions underline current best practice in childhood obesity treatment. Mobile health (mHealth) adjuncts that address eating and physical activity behaviors have shown promise in clinical studies. Objective: This study aimed to describe process methods for applying an mHealth intervention to reduce the rate of eating and monitor physical activity among children with obesity. Methods: The study protocol was designed to incorporate 2 mHealth apps as an adjunct to usual care treatment for obesity. Children and adolescents (aged 9-16 years) with obesity (BMI ?98th centile) were recruited in person from a weight management service at a tertiary health care center in the Republic of Ireland. Eligible participants and their parents received information leaflets, and informed consent and assent were signed. Participants completed 2 weeks of baseline testing, including behavioral and quality of life questionnaires, anthropometry, rate of eating by Mandolean, and physical activity level using a smart watch and the myBigO smartphone app. Thereafter, participants were randomized to the (1) intervention (usual clinical care+Mandolean training to reduce the rate of eating) or (2) control (usual clinical care) groups. Gender and age group (9.0-12.9 years and 13.0-16.9 years) stratifications were applied. At the end of a 4-week treatment period, participants repeated the 2-week testing period. Process evaluation measures included recruitment, study retention, fidelity parameters, acceptability, and user satisfaction. Results: A total of 20 participants were enrolled in the study. A web-based randomization system assigned 8 participants to the intervention group and 12 participants to the control group. Attrition rates were higher among the participants in the intervention group (5/8, 63\%) than those in the control group (3/12, 25\%). Intervention participants undertook a median of 1.0 training meal using Mandolean (25th centile 0, 75th centile 9.3), which represented 19.2\% of planned intervention exposure. Only 50\% (9/18) of participants with smart watches logged physical activity data. Significant differences in psychosocial profile were observed at baseline between the groups. The Child Behavior Checklist (CBCL) mean total score was 71.7 (SD 3.1) in the intervention group vs 57.6 (SD 6.6) in the control group, t-test P<.001, and also different among those who completed the planned protocol compared with those who withdrew early (CBCL mean total score 59.0, SD 9.3, vs 67.9, SD 5.6, respectively; t-test P=.04). Conclusions: A high early attrition rate was a key barrier to full study implementation. Perceived task burden in combination with behavioral issues may have contributed to attrition. Low exposure to the experimental intervention was explained by poor acceptability of Mandolean as a home-based tool for treatment. Self-monitoring using myBigO and the smartwatch was acceptable among this cohort. Further technical and usability studies are needed to improve adherence in our patient group in the tertiary setting. ",
doi="10.2196/16925",
url="https://mhealth.jmir.org/2020/7/e16925",
url="http://www.ncbi.nlm.nih.gov/pubmed/32673267"
}


@Article{info:doi/10.2196/15930,
author="Tang, K. Hong
and Nguyen, Ngoc-Minh
and Dibley, J. Michael
and Nguyen, D. Trang H. H.
and Alam, Ashraful",
title="Improving the Lifestyle of Adolescents Through Peer Education and Support in Vietnam: Protocol for a Pilot Cluster Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2020",
month="Jun",
day="26",
volume="9",
number="6",
pages="e15930",
keywords="peer education",
keywords="peer support",
keywords="peer leader",
keywords="adolescents",
keywords="dietary behaviors",
keywords="physical activity",
keywords="Vietnam",
abstract="Background: In Ho Chi Minh City, Vietnam, recent studies found a rapid increase in overweight and obesity in adolescents. There is a need for effective health promotion interventions to support healthy diets and encourage a physically active lifestyle. This study will help fill an evidence gap on effective interventions to prevent excess weight gain in adolescents and generate new insights about peer-led education to promote healthy lifestyles. Objective: We aim to assess the feasibility and acceptability of a combined peer-led and peer support intervention among junior high school students in Ho Chi Minh City. Additionally, the efficacy of the intervention on adolescents' dietary practices and time spent on physical activity will also be measured in this pilot study. Methods: The Peer Education and Peer Support (PEPS) project is a pilot cluster randomized controlled trial with 2 intervention and 2 control schools. The intervention consists of 4 weekly education sessions of why and how to choose healthy food and drinks and how to be more physically active. Additionally, the intervention includes a school-based and online support system to help maintain student engagement during the intervention. We will use in-depth interviews with students, peer leaders, teachers, and parents; focus group discussions with peer educators; and direct observation of the school environment and peer leaders' interactions with the students. Acceptability and feasibility of the intervention will be assessed. We will also quantitatively assess limited efficacy by measuring changes in student' physical activity levels and dietary behaviors. Results: We delivered the peer education intervention at the start of each school year over 3 months for all new grade 6 adolescents in the selected schools, followed by peer support and home engagement activities over 6 months until the end of the school year. There was a baseline assessment and 2 post-intervention assessments: the first immediately after the intervention to assess the short-term impact and the second at the end of the school year to assess the sustained impact on changes in adiposity, diet, and physical activity. Conclusions: The findings of this study will be used to develop a larger-scale cluster randomized controlled trial to examine the impact of a multicomponent, school- and home-based health promotion intervention. The trial will use innovative peer education methods to reduce overweight and obesity and improve dietary choices and physical activity levels in Vietnamese adolescents. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12619000421134; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376690\&isReview=true International Registered Report Identifier (IRRID): DERR1-10.2196/15930 ",
doi="10.2196/15930",
url="http://www.researchprotocols.org/2020/6/e15930/",
url="http://www.ncbi.nlm.nih.gov/pubmed/32589155"
}


@Article{info:doi/10.2196/19236,
author="Pizzoli, Francesca Silvia Maria
and Marzorati, Chiara
and Mazzoni, Davide
and Pravettoni, Gabriella",
title="An Internet-Based Intervention to Alleviate Stress During Social Isolation With Guided Relaxation and Meditation: Protocol for a Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2020",
month="Jun",
day="17",
volume="9",
number="6",
pages="e19236",
keywords="relaxation",
keywords="guided meditation",
keywords="internet-based intervention",
keywords="social isolation",
keywords="stress",
keywords="COVID-19",
keywords="mental health",
keywords="public health",
abstract="Background: Psychophysiological stress and decreased well-being are relevant issues during prolonged social isolation periods. Relaxation practices may represent helpful exercises to cope with anxiety and stressful sensations. Objective: The aim of this research protocol is to test whether remote relaxation practices such as natural sounds, deep respiration, and body scan meditation promote relaxation and improved emotional state and reduce psychomotor activation and the preoccupation related to the coronavirus disease (COVID-19) pandemic. Methods: The study population will consist of 3 experimental groups that will randomly receive one of 3 internet-based audio clips containing a single session of guided breathing exercise, guided body scan exercise, or natural sounds. The participants will listen to the fully automated audio clip for 7 minutes and complete pre-post self-assessment scales on their perceived relaxation, psychomotor activation, level of worry associated with COVID-19, and emotional state. At the end of the session, the participants will also be asked to provide qualitative reports on their subjective experiences. Results: Analyses will be performed to test the differences in the efficacy of the different audio clips in an internet-based intervention on 252 participants (84 per group), investigating whether natural sounds or remote guided practices such as deep respiration and body scan meditation positively enhance the participants' perceived psychological state. Conclusions: The study will provide information on if and to what extent guided practices can help in reducing psychological side effects related to social isolation during the COVID-19 pandemic. International Registered Report Identifier (IRRID): PRR1-10.2196/19236 ",
doi="10.2196/19236",
url="http://www.researchprotocols.org/2020/6/e19236/",
url="http://www.ncbi.nlm.nih.gov/pubmed/32530814"
}


@Article{info:doi/10.2196/15545,
author="Zou, Ping
and Stinson, Jennifer
and Parry, Monica
and Dennis, Cindy-Lee
and Yang, Yeqin
and Lu, Zhongqiu",
title="A Smartphone App (mDASHNa-CC) to Support Healthy Diet and Hypertension Control for Chinese Canadian Seniors: Protocol for Design, Usability and Feasibility Testing",
journal="JMIR Res Protoc",
year="2020",
month="Apr",
day="2",
volume="9",
number="4",
pages="e15545",
keywords="diet",
keywords="hypertension",
keywords="smartphone app",
keywords="senior",
keywords="Chinese",
keywords="Canada",
abstract="Background: This proposed study aims to translate the Dietary Approach to Stop Hypertension with Sodium (Na) Reduction for Chinese Canadians (DASHNa-CC), a classroom-based, antihypertensive, dietary educational intervention, to an innovative smartphone app (mDASHNa-CC). This study will enable Chinese Canadian seniors to access antihypertensive dietary interventions anytime, regardless of where they are. It is hypothesized that senior Chinese Canadians will be satisfied with their experiences using the mDASHNa-CC app and that the use of this app could lead to a decrease in their blood pressure and improvement in their health-related quality of life. Objective: The goal of this study is to design and test the usability and feasibility of a smartphone-based dietary educational app to support a healthy diet and hypertension control for Chinese Canadian seniors. Methods: A mixed-method two-phase design will be used. The study will be conducted in a Chinese immigrant community in Toronto, Ontario, Canada. Chinese Canadian seniors, who are at least 65 years old, self-identified as Chinese, living in Canada, and with elevated blood pressure, will be recruited. In Phase I, we will design and test the usability of the app using a user-centered approach. In Phase II, we will test the feasibility of the app, including implementation (primary outcomes of accrual and attrition rates, technical issues, acceptability of the app, and adherence to the intervention) and preliminary effectiveness (secondary outcomes of systolic and diastolic blood pressure, weight, waist circumference, health-related quality of life, and health service utilization), using a pilot, two-group, randomized controlled trial with a sample size of 60 participants in a Chinese Canadian community. Results: The study is supported by the Startup Research Grant from Nipissing University, Canada. The research ethics application is under review by a university research ethics review board. Conclusions: The study results will make several contributions to the existing literature, including illustrating the rigorous design and testing of smartphone app technology for hypertension self-management in the community, exploring an approach to incorporating traditional medicine into chronic illness management in minority communities and promoting equal access to current technology among minority immigrant senior groups. Trial Registration: Clinicaltrials.gov NCT03988894; https://clinicaltrials.gov/ct2/show/NCT03988894 International Registered Report Identifier (IRRID): PRR1-10.2196/15545 ",
doi="10.2196/15545",
url="https://www.researchprotocols.org/2020/4/e15545",
url="http://www.ncbi.nlm.nih.gov/pubmed/32238343"
}


@Article{info:doi/10.2196/15356,
author="Ramsey, Susan
and Ames, Evan
and Uber, Julia
and Habib, Samia
and Clark, Seth",
title="A Mobile Health App to Improve HIV Medication Adherence: Protocol for a Pilot Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2019",
month="Nov",
day="13",
volume="8",
number="11",
pages="e15356",
keywords="HIV",
keywords="medication adherence",
keywords="mobile health",
abstract="Background: Adherence to antiretroviral therapy (ART) is essential for allowing persons living with HIV to live longer, healthier lives. However, a large portion of this population has suboptimal adherence and are not virally suppressed. Conventional interventions aimed at improving ART adherence lack portability and scalability, and improvements in adherence are not often sustained. Mobile health (mHealth) ART interventions offer a low-cost and accessible method of improving adherence, but many have limited functionality and do not offer comprehensive support. The combination of an mHealth intervention with a face-to-face adherence intervention and interactive health coaching feature may offer sufficient support in a manner that is sensitive to resource limitations that are often found in HIV treatment settings. This paper details the protocol of a study designed to evaluate the potential of an enhanced mHealth intervention for improving ART adherence. Objective: The primary objective of this study is to assess the feasibility and acceptability of the Fitbit Plus app enhanced with a face-to-face LifeSteps session (Fitbit Plus condition) for improving ART adherence. In addition, we will determine the preliminary efficacy of the intervention by calculating treatment effect sizes. Methods: This study will be conducted in 2 phases. The intervention will be developed and piloted with a small group of participants during phase 1. Pilot participants will provide feedback that will be used to refine the intervention for phase 2. In phase 2, a preliminary randomized controlled trial (RCT) comparing Fitbit Plus with a condition that approximates the standard of care (SOC) will be conducted with 60 persons living with HIV. Interviews will be conducted with RCT participants at baseline, and follow-up interviews will be conducted at 1, 3, 6, and 12 months. ART adherence is the primary outcome and will be monitored throughout the study via electronic pill boxes. Effect sizes will be generated using a fractional logit model estimated by generalized estimating equations. Results: Phase 1 of this trial is complete; data collection for phase 2 is ongoing. Follow-ups with enrolled participants will conclude in January 2020. Conclusions: This study will contribute to the literature on ART adherence and may produce an efficacious intervention. Owing to a small sample size, there may be insufficient power to detect statistically significant differences between Fitbit Plus and SOC. However, if Fitbit Plus is found to be acceptable and feasible and yields promising effect size estimates, this pilot study could serve as the foundation for a larger, fully powered trial of Fitbit Plus. Trial Registration: ClinicalTrials.gov NCT02676128; https://clinicaltrials.gov/ct2/show/NCT02676128 International Registered Report Identifier (IRRID): DERR1-10.2196/15356 ",
doi="10.2196/15356",
url="http://www.researchprotocols.org/2019/11/e15356/",
url="http://www.ncbi.nlm.nih.gov/pubmed/31719030"
}


@Article{info:doi/10.2196/13651,
author="Pald{\'a}n, Katrin
and Simanovski, Jan
and Ullrich, Greta
and Steinmetz, Martin
and Rammos, Christos
and J{\'a}nosi, Alexander Rolf
and Moebus, Susanne
and Rassaf, Tienush
and Lortz, Julia",
title="Feasibility and Clinical Relevance of a Mobile Intervention Using TrackPAD to Support Supervised Exercise Therapy in Patients With Peripheral Arterial Disease: Study Protocol for a Randomized Controlled Pilot Trial",
journal="JMIR Res Protoc",
year="2019",
month="Jun",
day="26",
volume="8",
number="6",
pages="e13651",
keywords="peripheral arterial disease",
keywords="telemedicine",
keywords="patient participation",
keywords="patient compliance",
keywords="primary health care",
abstract="Background: Peripheral arterial disease (PAD) is a common and severe disease with a highly increased cardiovascular morbidity and mortality. Through the circulatory disorder and the linked undersupply of oxygen carriers in the lower limbs, the ongoing decrease of the pain-free walking distance occurs with a significant reduction in patients' quality of life. Studies including activity monitoring for patients with PAD are rare and digital support to increase activity via mobile health technologies is mainly targeted at patients with cardiovascular disease in general. The special requirement of patients with PAD is the need to reach a certain pain level to improve the pain-free walking distance. Unfortunately, both poor adherence and availability of institutional resources are major problems in patient-centered care. Objective: The objective of this trackPAD pilot study is to evaluate the feasibility of a mobile phone--based self tracking app to promote physical activity and supervised exercise therapy (SET) in particular. We also aim for a subsequent patient centered adjustment of the app prototype based on the results of the app evaluation and process evaluation. Methods: This study was designed as a closed user group trial, with assessors blinded, and parallel group study with face-to-face components for assessment with a follow-up of 3 months. Patients with symptomatic PAD (Fontaine stage IIa or IIb) and possession of a mobile phone were eligible. Eligible participants were randomly assigned into study and control group, stratified by their distance covered in the 6-min walk test, using the software TENALEA. Participants randomized to the study group received usual care and the mobile intervention (trackPAD) for the follow-up period of 3 months, whereas participants randomized to the control group received only usual care. TrackPAD records the frequency and duration of training sessions and pain level using manual user input. Clinical outcome data were collected at the baseline and after 3 months via validated tools (6-min walk test, ankle-brachial index, and duplex ultrasound at the lower arteries) and self-reported quality of life. Usability and quality of the app was determined using the user version of the Mobile Application Rating Scale. Results: The study enrolled 45 participants with symptomatic PAD (44\% male). Of these participants, 21 (47\%) were randomized to the study group and 24 (53\%) were randomized to the control group. The distance walked in the 6-min walk test was comparable in both groups at baseline (study group: mean 368.1m [SD 77.6] vs control group: mean 394.6m [SD 100.6]). Conclusions: This is the first trial to test a mobile intervention called trackPAD that was designed especially for patients with PAD. Its results will provide important insights in terms of feasibility, effectiveness, and patient preferences of an app-based mobile intervention supporting SET for the conservative treatment of PAD. International Registered Report Identifier (IRRID): DERR1-10.2196/13651 ",
doi="10.2196/13651",
url="http://www.researchprotocols.org/2019/6/e13651/",
url="http://www.ncbi.nlm.nih.gov/pubmed/31244477"
}


@Article{info:doi/10.2196/12940,
author="Grasaas, Erik
and Fegran, Liv
and Helseth, S{\o}lvi
and Stinson, Jennifer
and Martinez, Santiago
and Lalloo, Chitra
and Haraldstad, Kristin",
title="iCanCope With Pain: Cultural Adaptation and Usability Testing of a Self-Management App for Adolescents With Persistent Pain in Norway",
journal="JMIR Res Protoc",
year="2019",
month="Jun",
day="03",
volume="8",
number="6",
pages="e12940",
keywords="health",
keywords="self-management",
keywords="adolescent",
keywords="chronic pain",
keywords="translating",
keywords="mobile app",
abstract="Background: Persistent or chronic pain is a common health problem among adolescents. Thus, it is important that they receive evidence-based strategies for symptom management. iCanCope with Pain is a mobile phone app designed to help adolescents cope with chronic pain. The app comprises 5 evidence- and theory-based features: (I) symptom trackers for pain, sleep, mood, physical function, and energy; (II) goal setting to improve pain and function; (III) a coping toolbox of pain self-management strategies; (IV) social support; and (V) age-appropriate pain education. The iCanCope with Pain app is based on theory, identified health care needs, and current best practices for pain self-management. Objective: The objectives of this study were to describe the translation and cultural adaptation of the app into the Norwegian context and evaluate the app's usability using a phased approach. Methods: Phase 1 included translation and cultural adaptation of the app into the Norwegian context. This process used an expert panel of researchers and target group representatives who were responsible for the linguistic quality assurance and assessment. In phases 2 and 3 the app's usability was tested. For phase 2, the assessments of usability and user experiences included observation, the think aloud method, audiovisual recordings, questionnaires, and individual interviews in a laboratory setting. For phase 3, the assessment of usability and user experience over a 2-week home-based test included questionnaires and individual end-user interviews. Overall, app usability was determined based on ease of use, efficiency, and user satisfaction. Qualitative data were analyzed using deductive content analysis. Descriptive statistics were calculated for quantitative data. Results: End users did not report any misunderstandings or discrepancies with the words or phrasing of the translated and culturally adapted app. Participants in both the laboratory- and home-based usability tests found the app self-explanatory and reported that all 5 of its features were easy to use. All tasks were completed within the allocated time frame (ie, efficiency), with few errors. Overall System Usability Scale scores were high, with average scores of 82 and 89 out of 100 from laboratory- and field-based tests, respectively. Participants liked the idea of a social support function (feature IV), although qualitative and internet server data revealed that this feature was rarely used. Conclusions: This study described the cultural and linguistic adaptation and usability testing of the Norwegian version of the iCanCope with Pain app. High user satisfaction, ease of use, efficiency, and only minor errors cumulatively indicated that no changes to the app were needed, with the exception of facilitating user interaction within the social support feature. The app will be used in an upcoming randomized controlled trial with a larger sample. ",
doi="10.2196/12940",
url="https://www.researchprotocols.org/2019/6/e12940/",
url="http://www.ncbi.nlm.nih.gov/pubmed/31162132"
}


@Article{info:doi/10.2196/12455,
author="Hawkins, Marquis
and Iradukunda, Favorite
and Paterno, Mary",
title="Feasibility of a Sleep Self-Management Intervention in Pregnancy Using a Personalized Health Monitoring Device: Protocol for a Pilot Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2019",
month="May",
day="29",
volume="8",
number="5",
pages="e12455",
keywords="eHealth",
keywords="pregnancy",
keywords="personal health monitoring",
keywords="behavior",
keywords="maternal health",
abstract="Background: Sleep disruptions are common during pregnancy and associated with increased risk of adverse maternal outcomes such as preeclampsia, gestational diabetes, prolonged labor, and cesarean birth. Given the morbidity associated with poor sleep, cost-effective approaches to improving sleep that can be disseminated in community or clinical settings are needed. Personal health monitor (PHM) devices offer an opportunity to promote behavior change, but their acceptability and efficacy at improving sleep in pregnant women are unknown. Objective: The goal of the paper is to describe the protocol for an ongoing pilot randomized controlled trial that aims to establish the feasibility, acceptability, and preliminary efficacy of using a PHM device (Shine 2, Misfit) to promote sleep during pregnancy. Methods: The proposed pilot study is a 12-week, parallel arm, randomized controlled trial. Pregnant women, at 24 weeks gestation, will be randomized at a 1:1 ratio to a 12-week sleep education plus PHM device group or a sleep education alone comparison group. The primary outcomes will be measures of feasibility (ie, recruitment, enrollment, adherence) and acceptability (ie, participant satisfaction). The secondary outcomes will be self-reported sleep quality and duration, excessive daytime sleepiness, fatigue, and depressive symptoms. Results: Recruitment for this study began in September 2017 and ended in March 2018. Data collection for the primary and secondary aims was completed in August 2018. We anticipate that the data analysis for primary and secondary aims will be completed by December 2019. The results from this trial will inform the development of a larger National Institutes of Health grant application to test the efficacy of an enhanced version of the sleep intervention that we plan to submit in the year 2020. Conclusions: This study will be the first to apply a PHM device as a tool for promoting self-management of sleep among pregnant women. PHM devices have the potential to facilitate behavioral interventions because they include theory-driven, self-regulatory techniques such as behavioral self-monitoring. The results of the study will inform the development of a sleep health intervention for pregnant women. Trial Registration: ClinicalTrials.gov NCT03783663; https://clinicaltrials.gov/ct2/show/NCT03783663 (Archived by WebCite at http://www.webcitation.org/779Ou8hon) International Registered Report Identifier (IRRID): DERR1-10.2196/12455 ",
doi="10.2196/12455",
url="https://www.researchprotocols.org/2019/5/e12455/",
url="http://www.ncbi.nlm.nih.gov/pubmed/31144670"
}


@Article{info:doi/10.2196/11257,
author="Winters-Stone, M. Kerri
and Kenfield, A. Stacey
and Van Blarigan, L. Erin
and Moe, L. Esther
and Ramsdill, W. Justin
and Daniel, Kimi
and Macaire, Greta
and Paich, Kellie
and Kessler, R. Elizabeth
and Kucuk, Omer
and Gillespie, W. Theresa
and Lyons, S. Karen
and Beer, M. Tomasz
and Broering, M. Jeanette
and Carroll, R. Peter
and Chan, M. June",
title="Effect of Increasing Levels of Web-Based Behavioral Support on Changes in Physical Activity, Diet, and Symptoms in Men With Prostate Cancer: Protocol for a Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2018",
month="Nov",
day="15",
volume="7",
number="11",
pages="e11257",
keywords="prostatic neoplasm",
keywords="survivorship",
keywords="diet",
keywords="exercise",
keywords="internet",
keywords="behavior",
keywords="text messaging",
keywords="accelerometry",
abstract="Background: More than 3.1 million men in the United States are prostate cancer survivors. These men may improve their physical function, quality of life, and potentially their prognosis by adopting healthier lifestyle habits. The internet provides a scalable mechanism to deliver advice and support about improving physical activity and dietary habits, but the feasibility and acceptability of a Web-based lifestyle intervention and the dose of support necessary to improve health behaviors are not yet known. Objectives: The Community of Wellness is a Web-based intervention focused on supporting exercise and healthy dietary practices for men with prostate cancer. The objectives of this study were to determine the feasibility, acceptability, and preliminary efficacy of the Community of Wellness Web portal among prostate cancer survivors by conducting a randomized controlled trial (RCT) comparing 4 levels of additive Web-based content and interaction with participants: Level 1 (Teaching; Control), Level 2 (Teaching + Tailoring), Level 3 (Teaching + Tailoring + Technology), and Level 4 (Teaching + Tailoring + Technology + Touch). Methods: This is a single-blinded RCT comparing 3 levels of behavioral support within the Community of Wellness Web portal intervention (Levels 2 to 4) with each other and with the control condition (Level 1). The control condition receives general static Web-based educational information only on physical activity and dietary habits, self-efficacy for behavior change, motivation for physical activity, and changes in anxiety and treatment-related side effects. We will enroll and randomize 200 men with prostate cancer equally to 4 levels of the Community of Wellness Web-based intervention for 3 months (50 men per level). Surveys will be completed by self-report at baseline, 3 months (immediately postintervention), and 6 months (3 months postintervention). Feasibility and acceptability will be assessed by enrollment statistics, Web-based usage metrics, and surveys at the 3-month time point. We will also conduct focus groups after the postintervention follow-up assessment in a sample of enrolled participants to evaluate elements of usability and acceptability that cannot be obtained via surveys. Results: Enrollment is ongoing, with 124 enrolled. Study completion (6-month follow-up) is expected by July 2019. Conclusions: The goal of the study is to identify the level of support that is feasible, acceptable, promotes behavior change, and improves health in men with prostate cancer to inform future efforts to scale the program for broader reach. Trial Registration: ClinicalTrials.gov NCT03406013; https://clinicaltrials.gov/ct2/show/NCT03406013 (Archived by WebCite at http://www.webcitation.org/73YpDIoTX). International Registered Report Identifier (IRRID): PRR1-10.2196/11257 ",
doi="10.2196/11257",
url="http://www.researchprotocols.org/2018/11/e11257/",
url="http://www.ncbi.nlm.nih.gov/pubmed/30442638"
}


@Article{info:doi/10.2196/resprot.8886,
author="Chalmers, Alexander John
and Sansom-Daly, Margaret Ursula
and Patterson, Pandora
and McCowage, Geoffrey
and Anazodo, Antoinette",
title="Psychosocial Assessment Using Telehealth in Adolescents and Young Adults With Cancer: A Partially Randomized Patient Preference Pilot Study",
journal="JMIR Res Protoc",
year="2018",
month="Aug",
day="29",
volume="7",
number="8",
pages="e168",
keywords="telehealth",
keywords="videoconferencing",
keywords="psychosocial",
keywords="psychological assessment",
keywords="adolescent and young adult",
keywords="cancer",
abstract="Background: Adolescent and young adults with cancer are at increased risk of psychosocial difficulties relative to their healthy peers. Current models of inpatient face-to-face psychosocial care might limit the capacity for clinicians to provide timely and personalized assessment and intervention for this group. Telehealth offers a promising alternative toward increasing access to the provision of evidence-based psychosocial assessment and treatment for adolescent and young adults with cancer. Objective: This pilot study aimed to assess the feasibility and acceptability for both patients and clinicians of providing a psychosocial assessment via telehealth to adolescents and young adults currently receiving treatment for cancer, relative to face-to-face delivery. Methods: We included patients who were aged 15-25 years, currently receiving treatment, could speak English well, and medically stable. Patients were recruited from oncology clinics or wards from 5 hospitals located across Sydney and Canberra, Australia, and allocated them to receive psychosocial assessment (Adolescent and Young Adult Oncology Psychosocial Assessment Measure) with a clinical psychologist or social worker through face-to-face or telehealth modalities using a partially randomized patient preference model. Patients completed a pre- and postassessment questionnaire comprising validated and purposely designed feasibility and acceptability indices, including the impact of technical difficulties, if patients had their own devices; number of patients who were content with their group allocation; self-reported preference of modality; Treatment Credibility and Expectations Questionnaire; and Working Alliance Inventory. Clinicians also completed a postassessment questionnaire rating their impressions of the acceptability and feasibility of intervention delivery by each modality. Results: Of 29 patients approached, 23 consented to participate (response rate: 79\%). Participants were partially randomized to either telehealth (8/23, 35\%; mean age 16.50 years, range 15-23 years; females: 4/8, 50\%) or face-to-face (11/23, 62\%; mean age 17 years, range 15-22 years; females: 8/11, 72\%) conditions. Four participants withdrew consent because of logistical or medical complications (attrition rate: 17.4\%). Most participants (6/8, 75\%) in the telehealth group used their computer or iPad (2 were provided with an iPad), with minor technical difficulties occurring in 3 of 8 (37.5\%) assessments. Participants in both groups rated high working alliance (Working Alliance Inventory; median patient response in the telehealth group, 74, range 59-84 and face-to-face group, 63, range 51-84) and reported positive beliefs regarding the credibility and expectations of their treatment group. Postassessment preferences between face-to-face or telehealth modalities varied. Most patients in the telehealth group (5/8, 63\%) reported no preference, whereas 6 of 11 (55\%) in the face-to-face group reported a preference for the face-to-face modality. Conclusions: Telehealth is acceptable as patient comfort was comparable across modalities, with no significant technological barriers experienced. However, patients varied in their preferred interview modality, highlighting the need to tailor the treatment to patient preference and circumstances. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12614001142628; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366609 (Archived by WebCite at http://www.webcitation.org/721889HpE) ",
doi="10.2196/resprot.8886",
url="http://www.researchprotocols.org/2018/8/e168/",
url="http://www.ncbi.nlm.nih.gov/pubmed/30158103"
}


@Article{info:doi/10.2196/resprot.9850,
author="Rabbi, Mashfiqui
and Philyaw Kotov, Meredith
and Cunningham, Rebecca
and Bonar, E. Erin
and Nahum-Shani, Inbal
and Klasnja, Predrag
and Walton, Maureen
and Murphy, Susan",
title="Toward Increasing Engagement in Substance Use Data Collection: Development of the Substance Abuse Research Assistant App and Protocol for a Microrandomized Trial Using Adolescents and Emerging Adults",
journal="JMIR Res Protoc",
year="2018",
month="Jul",
day="18",
volume="7",
number="7",
pages="e166",
keywords="engagement",
keywords="microrandomized trial",
keywords="just-in-time adaptive intervention",
abstract="Background: Substance use is an alarming public health issue associated with significant morbidity and mortality. Adolescents and emerging adults are at particularly high risk because substance use typically initiates and peaks during this developmental period. Mobile health apps are a promising data collection and intervention delivery tool for substance-using youth as most teens and young adults own a mobile phone. However, engagement with data collection for most mobile health applications is low, and often, large fractions of users stop providing data after a week of use. Objective: Substance Abuse Research Assistant (SARA) is a mobile application to increase or sustain engagement of substance data collection overtime. SARA provides a variety of engagement strategies to incentivize data collection: a virtual aquarium in the app grows with fish and aquatic resources; occasionally, funny or inspirational contents (eg, memes or text messages) are provided to generate positive emotions. We plan to assess the efficacy of SARA's engagement strategies over time by conducting a micro-randomized trial, where the engagement strategies will be sequentially manipulated. Methods: We aim to recruit participants (aged 14-24 years), who report any binge drinking or marijuana use in the past month. Participants are instructed to use SARA for 1 month. During this period, participants are asked to complete one survey and two active tasks every day between 6 pm and midnight. Through the survey, we assess participants' daily mood, stress levels, loneliness, and hopefulness, while through the active tasks, we measure reaction time and spatial memory. To incentivize and support the data collection, a variety of engagement strategies are used. First, predata collection strategies include the following: (1) at 4 pm, a push notification may be issued with an inspirational message from a contemporary celebrity; or (2) at 6 pm, a push notification may be issued reminding about data collection and incentives. Second, postdata collection strategies include various rewards such as points which can be used to grow a virtual aquarium with fishes and other treasures and modest monetary rewards (up to US \$12; US \$1 for each 3-day streak); also, participants may receive funny or inspirational content as memes or gifs or visualizations of prior data. During the study, the participants will be randomized every day to receive different engagement strategies. In the primary analysis, we will assess whether issuing 4 pm push-notifications or memes or gifs, respectively, increases self-reporting on the current or the following day. Results: The microrandomized trial started on August 21, 2017 and the trial ended on February 28, 2018. Seventy-three participants were recruited. Data analysis is currently underway. Conclusions: To the best of our knowledge, SARA is the first mobile phone app that systematically manipulates engagement strategies in order to identify the best sequence of strategies that keep participants engaged in data collection. Once the optimal strategies to collect data are identified, future versions of SARA will use this data to provide just-in-time adaptive interventions to reduce substance use among youth. Trial Registration: ClinicalTrials.gov NCT03255317; https://clinicaltrials.gov/show/NCT03255317 (Archived by WebCite at http://www.webcitation.org/70raGWV0e) Registered Report Identifier: RR1-10.2196/9850 ",
doi="10.2196/resprot.9850",
url="http://www.researchprotocols.org/2018/7/e166/",
url="http://www.ncbi.nlm.nih.gov/pubmed/30021714"
}


@Article{info:doi/10.2196/11047,
author="van den Berg, J. Jacob
and Silverman, Taylor
and Fernandez, Isabel M.
and Henny, D. Kirk
and Gaul, J. Zaneta
and Sutton, Y. Madeline
and Operario, Don",
title="Using eHealth to Reach Black and Hispanic Men Who Have Sex With Men Regarding Treatment as Prevention and Preexposure Prophylaxis: Protocol for a Small Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2018",
month="Jul",
day="16",
volume="7",
number="7",
pages="e11047",
keywords="pre-exposure prophlaxis",
keywords="treatment as prevention",
keywords="men who have sex with men",
keywords="eHealth",
keywords="blacks",
keywords="African Americans",
keywords="Hispanic Americans",
keywords="Latinos",
keywords="HIV",
keywords="social media",
keywords="sexual and gender minorities",
keywords="telemedicine",
keywords="acquired immunodeficiency syndrome",
abstract="Background: Black and Hispanic men who have sex with men in the United States continue to be disproportionately affected by HIV and AIDS. Uptake of and knowledge about biobehavioral HIV prevention approaches, such as treatment as prevention and preexposure prophylaxis, are especially low in these populations. eHealth campaigns and social media messaging about treatment as prevention and preexposure prophylaxis may help to fill this gap in knowledge and lead to increased uptake of such strategies; however, no evidence exists of the effects of these targeted forms of communication on treatment as prevention and preexposure prophylaxis uptake in these populations. Objective: We describe the protocol for a 3-part study aiming to develop and evaluate an eHealth intervention with information about treatment as prevention and preexposure prophylaxis for HIV-positive and HIV-negative black and Hispanic men who have sex with men. Methods: Phases 1 and 2 will involve focus groups and cognitive interviews with members of the target populations, which we will use to create a culturally tailored, interactive website and applicable social media messaging for these men. Phase 3 will be a small randomized controlled trial of the eHealth intervention, in which participants will receive guided social media messages plus the newly developed website (active arm) or the website alone (control arm), with assessments at baseline and 6 months. Results: Participant recruitment began in August 2017 and will end in August 2020. Conclusions: Public health interventions are greatly needed to increase knowledge about and uptake of biobehavioral HIV prevention strategies such as treatment as prevention and preexposure prophylaxis among black and Hispanic men who have sex with men. eHealth communication campaigns offer a strategy for engaging these populations in health communication about biobehavioral HIV prevention. Trial Registration: ClinicalTrials.gov NCT03404531; https://www.clinicaltrials.gov/ct2/show/NCT03404531 (Archived by WebCite at http://www.webcitation.org/70myofp0R). Registered Report Identifier: RR1-10.2196/11047 ",
doi="10.2196/11047",
url="http://www.researchprotocols.org/2018/7/e11047/",
url="http://www.ncbi.nlm.nih.gov/pubmed/30012549"
}


@Article{info:doi/10.2196/10468,
author="Dutra, McCarl Lauren
and Nonnemaker, James
and Taylor, Nathaniel
and Kim, E. Annice",
title="Deception and Shopping Behavior Among Current Cigarette Smokers: A Web-Based, Randomized Virtual Shopping Experiment",
journal="JMIR Res Protoc",
year="2018",
month="Jun",
day="29",
volume="7",
number="6",
pages="e10468",
keywords="online shopping",
keywords="deception",
keywords="social and behavioral sciences",
keywords="consumer behavior",
keywords="smokers",
abstract="Background: Virtual stores can be used to identify influences on consumer shopping behavior. Deception is one technique that may be used to attempt to increase the realism of virtual stores. Objective: The objective of the experiment was to test whether the purchasing behavior of participants in a virtual shopping task varied based on whether they were told that they would receive the products they selected in a virtual convenience store (a form of deception) or not. Methods: We recruited a US national sample of 402 adult current smokers by email from an online panel of survey participants. They completed a fully automated randomized virtual shopping experiment with a US \$15 or US \$20 budget in a Web-based virtual convenience store. We told a random half of participants that they would receive the products they chose in the virtual store or the cash equivalent (intervention condition), and the other random half simply to conduct a shopping task (control condition). We tested for differences in demographics, tobacco use behaviors, and in-store purchases (outcome variable, assessed by questionnaire) by experimental condition. Results: The characteristics of the participants (398/402, 99.0\% with complete data) were comparable across conditions except that the intervention group contained slightly more female participants (103/197, 52.3\%) than the control group (84/201, 41.8\%; P=.04). We did not find any other significant differences in any other demographic variables or tobacco use, or in virtual store shopping behaviors, including purchasing any tobacco (P=.44); purchasing cigarettes (P=.16), e-cigarettes (P=.54), cigars (P=.98), or smokeless tobacco (P=.72); amount spent overall (P=.63) or on tobacco (P=.66); percentage of budget spent overall (P=.84) or on tobacco (P=.74); number of total items (P=.64) and tobacco items purchased (P=.54); or total time spent in the store (P=.07). Conclusions: We found that telling participants that they will receive the products they select in a virtual store did not influence their purchases. This finding suggests that deception may not affect consumer behavior and, as a result, may not be necessary in virtual shopping experiments. ",
doi="10.2196/10468",
url="http://www.researchprotocols.org/2018/6/e10468/",
url="http://www.ncbi.nlm.nih.gov/pubmed/29959114"
}


@Article{info:doi/10.2196/resprot.9421,
author="Kelleher, Erin
and Moreno, Megan
and Wilt, Pumper Megan",
title="Recruitment of Participants and Delivery of Online Mental Health Resources for Depressed Individuals Using Tumblr: Pilot Randomized Control Trial",
journal="JMIR Res Protoc",
year="2018",
month="Apr",
day="12",
volume="7",
number="4",
pages="e95",
keywords="adolescents",
keywords="depression",
keywords="intervention",
keywords="social media",
keywords="tumblr",
abstract="Background: Adolescents and young adults frequently post depression symptom references on social media; previous studies show positive associations between depression posts and self-reported depression symptoms. Depression is common among young people and this population often experiences many barriers to mental health care. Thus, social media may be a new resource to identify, recruit, and intervene with young people at risk for depression. Objective: The purpose of this pilot study was to test a social media intervention on Tumblr. We used social media to identify and recruit participants and to deliver the intervention of online depression resources. Methods: This randomized pilot intervention identified Tumblr users age 15-23 who posted about depression using the search term ``\#depress''. Eligible participants were recruited via Tumblr messages; consented participants completed depression surveys and were then randomized to an intervention of online mental health resources delivered via a Tumblr message, while control participants did not receive resources. Postintervention online surveys assessed resource access and usefulness and control groups were asked whether they would have liked to receive resources. Analyses included t tests. Results: A total of 25 participants met eligibility criteria. The mean age of the participants was 17.5 (SD 1.9) and 65\% were female with average score on the Patient Health Questionnaire-9 of 17.5 (SD 5.9). Among the 11 intervention participants, 36\% (4/11) reported accessing intervention resources and 64\% (7/11) felt the intervention was acceptable. Among the 14 control participants, only 29\% (4/14) of reported that receiving resources online would be acceptable (P=.02). Participants suggested anonymity and ease of use as important characteristics in an online depression resource. Conclusions: The intervention was appropriately targeted to young people at risk for depression, and recruitment via Tumblr was feasible. Most participants in the intervention group felt the social media approach was acceptable, and about a third utilized the online resources. Participants who had not experienced the intervention were less likely to find it acceptable. Future studies should explore this approach in larger samples. Social media may be an appropriate platform for online depression interventions for young people. ",
doi="10.2196/resprot.9421",
url="http://www.researchprotocols.org/2018/4/e95/",
url="http://www.ncbi.nlm.nih.gov/pubmed/29650507"
}


@Article{info:doi/10.2196/jmir.9723,
author="Everett, Estelle
and Kane, Brian
and Yoo, Ashley
and Dobs, Adrian
and Mathioudakis, Nestoras",
title="A Novel Approach for Fully Automated, Personalized Health Coaching for Adults with Prediabetes: Pilot Clinical Trial",
journal="J Med Internet Res",
year="2018",
month="Feb",
day="27",
volume="20",
number="2",
pages="e72",
keywords="mobile health",
keywords="prediabetes",
keywords="HbA       1c",
keywords="weight loss",
keywords="blood glucose",
abstract="Background: Prediabetes is?a?high-risk?state for the future development of type 2 diabetes, which may be prevented through physical activity (PA), adherence to a healthy diet, and weight loss. Mobile health (mHealth)?technology is a practical and cost-effective method of delivering diabetes prevention programs in a real-world setting. Sweetch (Sweetch?Health, Ltd)?is a?fully automated,?personalized mHealth platform designed to promote adherence to PA and?weight?reduction?in people?with prediabetes.? Objective: The objective of this pilot study was to calibrate the Sweetch app and?determine the feasibility, acceptability, safety, and effectiveness of the?Sweetch?app in combination with a digital body weight scale (DBWS) in adults with prediabetes. Methods: This was a 3-month prospective, single-arm, observational study of adults with a diagnosis of prediabetes and body mass index (BMI)?between 24 kg/m2 and 40 kg/m2. Feasibility was assessed by study retention. Acceptability of the mobile platform and DBWS were evaluated using validated questionnaires. Effectiveness measures included change in PA, weight, BMI, glycated hemoglobin (HbA1c), and fasting blood glucose from baseline to 3-month visit. The significance of changes in outcome measures was evaluated using paired t test or Wilcoxon matched pairs test. Results: The study retention rate was 47 out of 55 (86\%) participants. There was a high degree of acceptability of the Sweetch app, with a median (interquartile range [IQR]) score of 78\% (73\%-80\%) out of 100\% on the validated System Usability Scale. Satisfaction regarding the DBWS was also high, with median (IQR) score of 93\% (83\%-100\%). PA increased by 2.8 metabolic equivalent of task (MET)--hours per week (SD 6.8; P=.02), with mean weight loss of 1.6 kg (SD 2.5; P<.001) from baseline. The median change in A1c was ?0.1\% (IQR ?0.2\% to 0.1\%; P=.04), with no significant change in fasting blood glucose (?1 mg/dL; P=.59). There were no adverse events reported. Conclusions: The Sweetch mobile intervention program is a safe and effective method of increasing PA and reducing weight and HbA1c in adults with prediabetes. If sustained over a longer period, this intervention would be expected to reduce diabetes risk in this population. Trial Registration: ClincialTrials.gov NCT02896010; https://clinicaltrials.gov/ct2/show/NCT02896010 (Archived by WebCite at http://www.webcitation.org/6xJYxrgse) ",
doi="10.2196/jmir.9723",
url="http://www.jmir.org/2018/2/e72/",
url="http://www.ncbi.nlm.nih.gov/pubmed/29487046"
}


@Article{info:doi/10.2196/derma.8608,
author="Rodrigues, M. Angela
and Sniehotta, F. Falko
and Birch-Machin, A. Mark
and Olivier, Patrick
and Ara{\'u}jo-Soares, Vera",
title="Acceptability and Feasibility of a Trial Testing Allocation to Sunscreen and a Smartphone App for Sun Protection: Discontinued Randomized Controlled Trial",
journal="JMIR Dermatol",
year="2018",
month="Feb",
day="27",
volume="1",
number="1",
pages="e1",
keywords="sunscreening agents",
keywords="sun protection factor",
keywords="smartphone",
keywords="mobile applications",
keywords="feasibility studies",
keywords="randomized controlled trial",
keywords="skin neoplasms",
keywords="melanoma",
keywords="skin aging",
keywords="holidays",
keywords="health promotion",
keywords="health behavior",
abstract="Background: Recreational sun exposure has been associated with melanoma prevalence, and tourism settings are of particular interest for skin cancer prevention. Effective, affordable, and geographically flexible interventions to promote sun protection are needed. Objective: The aim of this study was to describe the protocol for a definitive randomized controlled trial (RCT) evaluating a smartphone mobile intervention (mISkin app) promoting sun protection in holidaymakers and to assess the acceptability and feasibility of the mISkin app and associated trial procedures in an internal pilot study. Methods: Participants were recruited from the general community. Holidaymakers traveling abroad and owning a smartphone were enrolled in the internal pilot of a 2 (mISkin vs control) x 2 (sun protection factor [SPF] 15 vs SPF 30) RCT with a postholiday follow-up. The smartphone app is fully automated and entails a behavioral intervention to promote sun protection. It consisted of five components: skin assessment, educational videos, ultraviolet (UV) photos, gamification, and prompts for sun protection. Participants were also randomly allocated to receive sunscreen SPF 15 or SPF 30. Primary outcomes for the internal pilot study were acceptability and feasibility of trial procedures and intervention features. Secondary outcomes were collected at baseline and after holidays through face-to-face-assessments and included skin sun damage, sunscreen use (residual weight and application events), and sun protection practices (Web-based questionnaire). Results: From 142 registers of interest, 42 participants were randomized (76\% [32/42] female; mean age 35.5 years). Outcome assessments were completed by all participants. Random allocation to SPF 15 versus SPF 30 was found not to be feasible in a definitive trial protocol. Of the 21 people allocated to the mISkin intervention, 19 (91\%) installed the mISkin on their phones, and 18 (86\%) used it at least once. Participants were satisfied with the mISkin app and made suggestions for further improvements. Due to difficulties with the random allocation to SPF and slow uptake, the trial was discontinued. Conclusions: The internal pilot study concluded that randomization to SPF was not feasible and that recruitment rate was slower than expected because of difficulties with gatekeeper engagement. Possible solutions to the problems identified are discussed. Further refinements to the mISkin app are needed before a definitive trial. Trial Registration: International Standard Randomized Controlled Trial Number ISRCTN63943558; http://www.isrctn.com/ISRCTN63943558 (Archived by WebCite at?http://www.webcitation.org/6xOLvbab8) ",
doi="10.2196/derma.8608",
url="https://derma.jmir.org/2018/1/e1/"
}


@Article{info:doi/10.2196/resprot.9118,
author="Song, Lixin
and Dunlap, L. Kaitlyn
and Tan, Xianming
and Chen, C. Ronald
and Nielsen, E. Matthew
and Rabenberg, L. Rebecca
and Asafu-Adjei, K. Josephine
and Koontz, F. Bridget
and Birken, A. Sarah
and Northouse, L. Laurel
and Mayer, K. Deborah",
title="Enhancing Survivorship Care Planning for Patients With Localized Prostate Cancer Using a Couple-Focused mHealth Symptom Self-Management Program: Protocol for a Feasibility Study",
journal="JMIR Res Protoc",
year="2018",
month="Feb",
day="26",
volume="7",
number="2",
pages="e51",
keywords="survivorship",
keywords="prostate cancer",
keywords="symptom, randomized trial",
keywords="mHealth",
keywords="caregiver",
keywords="Patient Reported Outcome Measures",
abstract="Background: This project explores a new model of care that enhances survivorship care planning and promotes health for men with localized prostate cancer transitioning to posttreatment self-management. Survivorship care planning is important for patients with prostate cancer because of its high incidence rate in the United States, the frequent occurrence of treatment-related side effects, and reduced quality of life (QOL) for both men and their partners. A key component of comprehensive survivorship care planning is survivorship care plans (SCPs), documents that summarize cancer diagnosis, treatment, and plans for follow-up care. However, research concerning the effectiveness of SCPs on patient outcomes or health service use has thus far been inconclusive. SCPs that are tailored to individual patients' needs for information and care may improve effectiveness. Objective: This study aims to examine the feasibility of an enhanced survivorship care plan (ESCP) that integrates a symptom self-management mHealth program called Prostate Cancer Education and Resources for Couples (PERC) into the existing standardized SCP. The specific aims are to (1) examine the feasibility of delivering ESCPs and (2) to estimate the magnitude of benefit of ESCPs. Methods: We will use a two-group randomized controlled pretest-posttest design and collect data at baseline (T1) and 4 months later (T2) among 50 patients completing initial treatment for localized prostate cancer and their partners. First, we will assess the feasibility of ESCP by recruitment, enrollment, and retention rates; program satisfaction with the ESCP; and perceived ease of use of the ESCP. To achieve the secondary aim, we will compare the ESCP users with the standardized SCP users and assess their primary outcomes of QOL (overall, physical, emotional, and social QOL); secondary outcomes (reduction in negative appraisals and improvement in self-efficacy, social support, and health behaviors to manage symptoms); and number of visits to posttreatment care services between T1 and T2. We will assess the primary and secondary outcomes using measurements with sound psychometrical properties. We will use a qualitative and quantitative mixed methods approach to achieve the research aims. Results: This project is ongoing and will be completed by the end of 2018. Conclusions: The results from this study will help design a definitive randomized trial to test the efficacy of the ESCPs, a potentially scalable program, to enhance supportive care for prostate cancer patients and their families. ",
doi="10.2196/resprot.9118",
url="http://www.researchprotocols.org/2018/2/e51/",
url="http://www.ncbi.nlm.nih.gov/pubmed/29483070"
}


@Article{info:doi/10.2196/cancer.8250,
author="Wilson, Carlene
and Flight, Ingrid
and Zajac, T. Ian
and Turnbull, Deborah
and Young, P. Graeme
and Olver, Ian",
title="Web-Based Communication Strategies Designed to Improve Intention to Minimize Risk for Colorectal Cancer: Randomized Controlled Trial",
journal="JMIR Cancer",
year="2018",
month="Feb",
day="12",
volume="4",
number="1",
pages="e2",
keywords="internet",
keywords="randomized controlled trial",
keywords="information seeking behavior",
keywords="consumer health information",
keywords="health communication",
abstract="Background: People seek information on the Web for managing their colorectal cancer (CRC) risk but retrieve much personally irrelevant material. Targeting information pertinent to this cohort via a frequently asked question (FAQ) format could improve outcomes. Objective: We identified and prioritized colorectal cancer information for men and women aged 35 to 74 years (study 1) and built a website containing FAQs ordered by age and gender. In study 2, we conducted a randomized controlled trial (RCT) to test whether targeted FAQs were more influential on intention to act on CRC risk than the same information accessed via a generic topic list. Secondary analyses compared preference for information delivery, usability, relevance, and likelihood of recommendation of FAQ and LIST websites. Methods: Study 1 determined the colorectal cancer information needs of Australians (N=600) by sex and age group (35-49, 50-59, 60-74) through a Web-based survey. Free-text responses were categorized as FAQs: the top 5 issues within each of the 6 cohorts were identified. Study 2 (N=240) compared the impact of presentation as targeted FAQ links to information with links presented as a generic list (LIST) and a CONTROL (no information) condition. We also tested preference for presentation of access to information as FAQ or LIST by adding a CHOICE condition (a self-selected choice of FAQs or a list of information topics). Results: Study 1 showed considerable consistency in information priorities among all 6 cohorts with 2 main concerns: treatment of CRC and risk factors. Some differences included a focus on general risk factors, excluding diet and lifestyle, in the younger cohort, and on the existence of a test for CRC in the older cohorts. Study 2 demonstrated that, although respondents preferred information access ordered by FAQs over a list, presentation in this format had limited impact on readiness to act on colorectal cancer risk compared with the list or a no-information control (P=.06). Both FAQ and LIST were evaluated as equally usable. Those aged 35 to 49 years rated the information less relevant to them and others in their age group, and information ordered by FAQs was rated, across all age groups and both sexes, as less relevant to people outside the age group targeted within the FAQs. Conclusions: FAQs are preferred over a list as a strategy for presenting access to information about CRC. They may improve intention to act on risk, although further research is required. Future research should aim to identify better the characteristics of information content and presentation that optimize perceived relevance and fully engage the target audience. Trial Registration: Australian New Zealand Clinical Trials Registry: ACTRN12618000137291; https://www.anzctr.org. au/Trial/Registration/TrialReview.aspx?id=374129 (Archived by WebCite at http://www.webcitation.org/6x2Mr6rPC) ",
doi="10.2196/cancer.8250",
url="http://cancer.jmir.org/2018/1/e2/",
url="http://www.ncbi.nlm.nih.gov/pubmed/29434013"
}


@Article{info:doi/10.2196/resprot.8541,
author="Oishi, Satoru
and Takizawa, Takeya
and Kamata, Naoki
and Miyaji, Shingo
and Tanaka, Katsutoshi
and Miyaoka, Hitoshi",
title="Web-Based Training Program Using Cognitive Behavioral Therapy to Enhance Cognitive Flexibility and Alleviate Psychological Distress Among Schoolteachers: Pilot Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2018",
month="Jan",
day="26",
volume="7",
number="1",
pages="e32",
keywords="school teachers",
keywords="education",
keywords="cognitive therapy",
keywords="randomized controlled trial",
abstract="Background: Schoolteachers are known to be faced with various stresses in their work. A simple, less onerous, and effective intervention technique that can enhance the stress management skills, particularly, cognitive flexibility, of schoolteachers is needed. Objective: This study aimed to determine whether stress management training using a Web-based cognitive behavioral therapy (CBT) program is effective for enhancing the cognitive flexibility of schoolteachers and alleviating their subjective distress. Methods: This study was conducted in a random controlled design covering public elementary schoolteachers. Teachers allocated to the intervention group received 120 min of group education and completed homework using a Web-based CBT program that lasted for 3 months. The items of outcome evaluation were cognitive flexibility and subjective distress, and the efficacy of intervention was evaluated at 3 months after intervention. Results: A total of 240 participants were randomly allocated to the intervention group (120 individuals) and the control group (120 individuals). On the basis of the principle of intention to treat, the intervention group and the control group were compared regarding the amount of change from before intervention to after intervention, using a general linear model. Scores of cognitive flexibility and subjective distress were significantly more improved in the intervention group than in the control group. Conclusions: The results of this study suggest that simple stress management training using a Web-based CBT program in elementary schoolteachers enhances cognitive flexibility and alleviates subjective distress. ",
doi="10.2196/resprot.8541",
url="http://www.researchprotocols.org/2018/1/e32/",
url="http://www.ncbi.nlm.nih.gov/pubmed/29374006"
}


@Article{info:doi/10.2196/resprot.6615,
author="Ritvo, Paul
and Obadia, Maya
and Santa Mina, Daniel
and Alibhai, Shabbir
and Sabiston, Catherine
and Oh, Paul
and Campbell, Kristin
and McCready, David
and Auger, Leslie
and Jones, Michelle Jennifer",
title="Smartphone-Enabled Health Coaching Intervention (iMOVE) to Promote Long-Term Maintenance of Physical Activity in Breast Cancer Survivors: Protocol for a Feasibility Pilot Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2017",
month="Aug",
day="24",
volume="6",
number="8",
pages="e165",
keywords="breast neoplasm",
keywords="exercise",
keywords="health coaching",
keywords="RCT",
keywords="telehealth",
abstract="Background: Although physical activity has been shown to contribute to long-term disease control and health in breast cancer survivors, a majority of breast cancer survivors do not meet physical activity guidelines. Past research has focused on promoting physical activity components for short-term breast cancer survivor benefits, but insufficient attention has been devoted to long-term outcomes and sustained exercise adherence. We are assessing a health coach intervention (iMOVE) that uses mobile technology to increase and sustain physical activity maintenance in initially inactive breast cancer survivors. Objective: This pilot randomized controlled trial (RCT) is an initial step in evaluating the iMOVE intervention and will inform development of a full-scale pragmatic RCT. Methods: We will enroll 107 physically inactive breast cancer survivors and randomly assign them to intervention or control groups at the University Health Network, a tertiary cancer care center in Toronto, Canada. Participants will be women (age 18 to 74 years) stratified by age (55 years and older/younger than 55 years) and adjuvant hormone therapy (AHT) exposure (AHT vs no AHT) following breast cancer treatment with no metastases or recurrence who report less than 60 minutes of preplanned physical activity per week. Both intervention and control groups receive the 12-week physical activity program with weekly group sessions and an individualized, progressive, home-based exercise program. The intervention group will additionally receive (1) 10 telephone-based health coaching sessions, (2) smartphone with data plan, if needed, (3) supportive health tracking software (Connected Wellness, NexJ Health Inc), and (4) a wearable step-counting device linked to a smartphone program. Results: We will be assessing recruitment rates; acceptability reflected in selective, semistructured interviews; and enrollment, retention, and adherence quantitative intervention markers as pilot outcome measures. The primary clinical outcome will be directly measured peak oxygen consumption. Secondary clinical outcomes include health-related quality of life and anthropometric measures. All outcome measures are administered at baseline, after exercise program (month 3), and 6 months after program (month 9). Conclusions: This pilot RCT will inform full-scale RCT planning. We will assess pilot procedures and interventions and collect preliminary effect estimates. Trial Registration: ClinicalTrials.gov NCT02620735; https://clinicaltrials.gov/ct2/show/NCT02620735 (Archived by WebCite at https://clinicaltrials.gov/ct2/show/NCT02620735) ",
doi="10.2196/resprot.6615",
url="http://www.researchprotocols.org/2017/8/e165/",
url="http://www.ncbi.nlm.nih.gov/pubmed/28838886"
}


@Article{info:doi/10.2196/jmir.6639,
author="Boogerd, Emiel
and Maas-Van Schaaijk, M. Nienke
and Sas, C. Theo
and Clement-de Boers, Agnes
and Smallenbroek, Mischa
and Nuboer, Roos
and Noordam, Cees
and Verhaak, M. Chris",
title="Sugarsquare, a Web-Based Patient Portal for Parents of a Child With Type 1 Diabetes: Multicenter Randomized Controlled Feasibility Trial",
journal="J Med Internet Res",
year="2017",
month="Aug",
day="22",
volume="19",
number="8",
pages="e287",
keywords="diabetes mellitus, type 1",
keywords="parenting",
keywords="health communication",
keywords="peer group",
keywords="telemedicine",
keywords="Internet",
abstract="Background: Raising a child with type 1 diabetes (T1D) means combining the demands of the disease management with everyday parenting, which is associated with increased levels of distress. A Web-based patient portal, Sugarsquare, was developed to support parents, by providing online parent-professional communication, online peer support and online disease information. Objective: The first aim of this study was to assess the feasibility of conducting a multicenter, randomized controlled trial in Dutch parents of a child with T1D. The second aim was to assess the feasibility of implementing Sugarsquare in clinical practice. Methods: The parents of 105 children (N=105) with T1D below the age of 13 participated in a 6-month multicenter randomized controlled feasibility trial. They were randomly assigned to an experimental (n=54, usual care and Sugarsquare) or a control group (n=51, usual care). Attrition rates and user statistics were gathered to evaluate feasibility of the trial and implementation. To determine potential efficacy, the parenting stress index (PSI-SF) was assessed at baseline (T0) and after 6 months (T1). Results: Of a potential population of parents of 445 children, 189 were willing to participate (enrollment refusal=57.5\%, n=256), 142 filled in the baseline questionnaire (baseline attrition rate=25\%, n=47), and 105 also filled in the questionnaire at T1 (post randomization attrition rate during follow-up=26\%, n=32). As such, 24\% of the potential population participated. Analysis in the experimental group (n=54) revealed a total of 32 (59\%) unique users, divided into 12 (38\%) frequent users, 9 (28\%) incidental users, and 11 (34\%) low-frequent users. Of the total of 44 professionals, 34 (77\%) logged in, and 32 (73\%) logged in repeatedly. Analysis of the user statistics in the experimental group further showed high practicability and integration in all users, moderate acceptability and demand in parents, and high acceptability and demand in health care professionals. Baseline parenting stress index scores were related to the parents' frequency of logging on ($\rho$=.282, P=.03) and page-views ($\rho$=.304, P=.01). No significant differences in change in parenting stress between experimental and control group were found (F3,101=.49, P=.49). Conclusions: The trial can be considered feasible, considering the average enrollment refusal rate, baseline attrition rate and postrandomization attrition rate, compared to other eHealth studies, although lower than hypothesized. Implementing Sugarsquare in clinical practice was partly feasible, given moderate demand and acceptability in parent users and lack of potential efficacy. Parents who reported higher levels of parenting stress used Sugarsquare more often than other parents, although Sugarsquare did not reduce parenting stress. These results indicate that Web-based interventions are a suitable way of providing parents of children with T1D with additional support. Future studies should determine how Sugarsquare could reduce parenting stress, for instance by adding targeted interventions. Factors potentially contributing to successful implementation are suggested. Trial Registration: Nederlands Trial Register Number: NTR3643; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3643 (Archived by WebCite at http://www.webcitation.org/6qihOVCi6) ",
doi="10.2196/jmir.6639",
url="http://www.jmir.org/2017/8/e287/",
url="http://www.ncbi.nlm.nih.gov/pubmed/28830853"
}


@Article{info:doi/10.2196/resprot.7203,
author="Hirsch, Abigail
and Luellen, Jason
and Holder, M. Jared
and Steinberg, Gregory
and Dubiel, Teresa
and Blazejowskyj, Anna
and Schladweiler, Krista",
title="Managing Depressive Symptoms in the Workplace Using a Web-Based Self-Care Tool: A Pilot Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2017",
month="Apr",
day="04",
volume="6",
number="4",
pages="e51",
keywords="depression",
keywords="behavioral health",
keywords="health promotion",
keywords="workplace",
keywords="randomized controlled trial",
abstract="Background: Depression in the workplace creates a significant burden on employees and employers in terms of lost productivity and related costs. myStrength provides a robust, holistic Web- and mobile-based solution empowering users to learn, practice, and implement a range of evidence-based psychological interventions. Objective: The main aim of this study was to demonstrate improvement in depressive symptoms among employees at risk of depression through myStrength use. Methods: A 26-week, parallel-arm, pilot, randomized controlled trial was designed to assess the effectiveness of myStrength compared to a series of informational ``Depression Tip/Fact of the Week'' emails as the active control arm. Study participants (n=146) were commercially insured employees of a mid-sized financial software solutions firm. The primary outcome was self-reported change in depression score as best fit by a linear random effects model accounting for individual baseline symptoms. Results: The final sample consisted of 78 participants in the experimental arm, myStrength, and 68 participants in the active control arm. myStrength users demonstrated significantly steeper and more rapid reduction in depressive symptoms over time compared to the active control (P<.001), suggesting that the intervention generated improvement in behavioral health symptoms, even in a nonclinical sample. Conclusions: This pilot study builds foundational support for the scalable deployment of myStrength as a complementary behavioral health offering to promote overall mental health and well-being in the workplace. ",
doi="10.2196/resprot.7203",
url="http://www.researchprotocols.org/2017/4/e51/",
url="http://www.ncbi.nlm.nih.gov/pubmed/28377368"
}


@Article{info:doi/10.2196/resprot.5735,
author="Ammerlaan, W. Judy
and Mulder, K. Olga
and de Boer-Nijhof, C. Nienke
and Maat, Bertha
and Kruize, A. Aike
and van Laar, Jaap
and van Os-Medendorp, Harmieke
and Geenen, Rinie",
title="Building a Tailored, Patient-Guided, Web-Based Self-Management Intervention `ReumaUitgedaagd!' for Adults With a Rheumatic Disease: Results of a Usability Study and Design for a Randomized Control Trail",
journal="JMIR Res Protoc",
year="2016",
month="Jun",
day="23",
volume="5",
number="2",
pages="e113",
keywords="Web-based",
keywords="self-management",
keywords="tailored",
keywords="intervention",
keywords="pilot study",
keywords="randomized controlled trial",
keywords="personal goal",
keywords="rheumatic diseases",
abstract="Background: The chronic nature of rheumatic diseases imposes daily challenges upon those affected and causes patients to make daily decisions about the way they self-manage their illness. Although there is attention to self-management and evidence for the desirability of tailored interventions to support people with a rheumatic disease, interventions based on individual needs and preferences are scarce. Objective: To provide a systematic and comprehensive description of the theoretical considerations for building a Web-based, expert, patient-guided, and tailored intervention for adult patients with a rheumatic disease. Also, to present the results of a usability study on the feasibility of this intervention, and its study design in order to measure the effectiveness. Methods: To fit the intervention closely to the autonomy, needs, and preferences of the individual patient, a research team comprising patient representatives, health professionals, Web technicians, and communication experts was formed. The research team followed the new guidance by the Medical Research Council (MRC) for developing and evaluating complex interventions as a guide for the design of the intervention. Results: Considerations from self-determination theory and a comprehensive assessment of preferences and needs in patients with a rheumatic disease guided the development of the Web-based intervention. The usability study showed that the intervention was useful, easy to use, and accepted and appreciated by the target group of patients. The planned randomized controlled trial is designed to be conducted among 120 adults with a rheumatic disease, who are assigned to the self-management intervention or a self-help control group. Both groups will be asked to formulate personal goals they want to achieve concerning their self-management. Progress toward the personal goal is the primary outcome measure of this study. Self-reported Web-based measures will be assessed before randomization at baseline, and 3 and 6 months after randomization. Also, feasibility and adherence to the Web-based self-management intervention as process outcomes will be evaluated. Conclusion: By identifying the individual goals at the beginning of the intervention and customizing the intervention to the individual patient, we aim to improve the usefulness and effectiveness of the Web-based self-management intervention. If proven effective, ReumaUitgedaagd! Online will be implemented in the Netherlands. ",
doi="10.2196/resprot.5735",
url="http://www.researchprotocols.org/2016/2/e113/",
url="http://www.ncbi.nlm.nih.gov/pubmed/27339472"
}


@Article{info:doi/10.2196/resprot.4837,
author="Geense, W. Wytske
and van Gaal, GI Betsie
and Knoll, L. Jacqueline
and Cornelissen, AM Elisabeth
and Schoonhoven, Lisette
and Kok, Gerjo",
title="Online Support Program for Parents of Children With a Chronic Kidney Disease Using Intervention Mapping: A Development and Evaluation Protocol",
journal="JMIR Res Protoc",
year="2016",
month="Jan",
day="13",
volume="5",
number="1",
pages="e1",
keywords="child",
keywords="chronic kidney failure",
keywords="family health",
keywords="health promotion",
keywords="intervention mapping",
keywords="parents",
keywords="program development",
keywords="telemedicine",
abstract="Background: The care for children with a chronic kidney disease (CKD) is complex. Parents of these children may experience high levels of stress in managing their child's disease, potentially leading to negative effects on their child's health outcomes. Although the experienced problems are well known, adequate (online) support for these parents is lacking. Objective: The objective of the study is to describe the systematic development of an online support program for parents of children with CKD, and how this program will be evaluated. Methods: Intervention Mapping (IM) was used for the development of the program. After conducting a needs assessment, defining program objectives, searching for theories, and selecting practical applications, the online program e-Powered Parents was developed. e-Powered Parents consist of three parts: (1) an informative part with information about CKD and treatments, (2) an interactive part where parents can communicate with other parents and health care professionals by chat, private messages, and a forum, and (3) a training platform consisting of four modules: Managing stress, Setting limits, Communication, and Coping with emotions. In a feasibility study, the potential effectiveness and effect size of e-Powered Parents will be evaluated using an explorative randomized controlled trial with parents of 120 families. The outcomes will be the child's quality of life, parental stress and fatigue, self-efficacy in the communication with health care professionals, and family management. A process evaluation will provide insight in parents' experiences, including their experienced level of support. Results: Study results are expected to be published in the summer of 2016. Conclusions: Although the development of e-Powered Parents using IM was time-consuming, IM has been a useful protocol. IM provided us with a systematic framework for structuring the development process. The participatory planning group was valuable as well; knowledge, experiences, and visions were shared, ensuring us that parents and health care professionals support the program. Trial Registration: Dutch Trial Registration: NTR4808; www.trialregister.nl (Archived by WebCite at http://www.webcitation.org/6cfAYHcYb) ",
doi="10.2196/resprot.4837",
url="http://www.researchprotocols.org/2016/1/e1/",
url="http://www.ncbi.nlm.nih.gov/pubmed/26764218"
}


@Article{info:doi/10.2196/resprot.4285,
author="Brewer, C. LaPrincess
and Kaihoi, Brian
and Zarling, K. Kathleen
and Squires, W. Ray
and Thomas, Randal
and Kopecky, Stephen",
title="The Use of Virtual World-Based Cardiac Rehabilitation to Encourage Healthy Lifestyle Choices Among Cardiac Patients: Intervention Development and Pilot Study Protocol",
journal="JMIR Res Protoc",
year="2015",
month="Apr",
day="08",
volume="4",
number="2",
pages="e39",
keywords="cardiac rehabilitation",
keywords="cardiovascular diseases",
keywords="eHealth",
keywords="telemedicine",
keywords="Internet",
keywords="health behavior",
abstract="Background: Despite proven benefits through the secondary prevention of cardiovascular disease (CVD) and reduction of mortality, cardiac rehabilitation (CR) remains underutilized in cardiac patients. Underserved populations most affected by CVD including rural residents, low socioeconomic status patients, and racial/ethnic minorities have the lowest participation rates due to access barriers. Internet-and mobile-based lifestyle interventions have emerged as potential modalities to complement and increase accessibility to CR. An outpatient CR program using virtual world technology may provide an effective alternative to conventional CR by overcoming patient access limitations such as geographics, work schedule constraints, and transportation. Objective: The objective of this paper is to describe the research protocol of a two-phased, pilot study that will assess the feasibility (Phase 1) and comparative effectiveness (Phase 2) of a virtual world-based (Second Life) CR program as an extension of a conventional CR program in achieving healthy behavioral change among post-acute coronary syndrome (ACS) and post-percutaneous coronary intervention (PCI) patients. We hypothesize that virtual world CR users will improve behaviors (physical activity, diet, and smoking) to a greater degree than conventional CR participants. Methods: In Phase 1, we will recruit at least 10 patients enrolled in outpatient CR who were recently hospitalized for an ACS (unstable angina, ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction) or who recently underwent elective PCI at Mayo Clinic Hospital, Rochester Campus in Rochester, MN with at least one modifiable, lifestyle risk factor target (sedentary lifestyle, unhealthy diet, and current smoking). Recruited patients will participate in a 12-week, virtual world health education program which will provide feedback on the feasibility, usability, and design of the intervention. During Phase 2, we will conduct a 2-arm, parallel group, single-center, randomized controlled trial (RCT). Patients will be randomized at a 1:1 ratio to adjunct virtual world-based CR with conventional CR or conventional CR only. The primary outcome is a composite including at least one of the following (1) at least 150 minutes of physical activity per week, (2) daily consumption of five or more fruits and vegetables, and (3) smoking cessation. Patients will be assessed at 3, 6, and 12 months. Results: The Phase 1 feasibility study is currently open for recruitment which will be followed by the Phase 2 RCT. The anticipated completion date for the study is May 2016. Conclusions: While research on the use of virtual world technology in health programs is in its infancy, it offers unique advantages over current Web-based health interventions including social interactivity and active learning. It also increases accessibility to vulnerable populations who have higher burdens of CVD. This study will yield results on the effectiveness of a virtual world-based CR program as an innovative platform to influence healthy lifestyle behavior and self-efficacy. ",
doi="10.2196/resprot.4285",
url="http://www.researchprotocols.org/2015/2/e39/",
url="http://www.ncbi.nlm.nih.gov/pubmed/25857331"
}


@Article{info:doi/10.2196/resprot.3716,
author="Swallow, M. Veronica
and Knafl, Kathleen
and Santacroce, Sheila
and Campbell, Malcolm
and Hall, G. Andrew
and Smith, Trish
and Carolan, Ian",
title="An Interactive Health Communication Application for Supporting Parents Managing Childhood Long-Term Conditions: Outcomes of a Randomized Controlled Feasibility Trial",
journal="JMIR Res Protoc",
year="2014",
month="Dec",
day="03",
volume="3",
number="4",
pages="e69",
keywords="child",
keywords="chronic condition",
keywords="chronic kidney disease, CKD",
keywords="family",
keywords="feasibility",
keywords="interactive health communication application",
keywords="online",
keywords="long-term condition",
keywords="parent",
keywords="randomized controlled trial",
abstract="Background: Families living with chronic or long-term conditions such as chronic kidney disease (CKD), stages 3-5, face multiple challenges and respond to these challenges in various ways. Some families adapt well while others struggle, and family response to a condition is closely related to outcome. With families and professionals, we developed a novel condition-specific interactive health communication app to improve parents' management ability---the online parent information and support (OPIS) program. OPIS consists of a comprehensive mix of clinical caregiving and psychosocial information and support. Objective: The purpose of this study was to (1) assess feasibility of a future full-scale randomized controlled trial (RCT) of OPIS in terms of recruitment and retention, data collection procedures, and psychometric performance of the study measures in the target population, and (2) investigate trends in change in outcome measures in a small-scale RCT in parents of children with CKD stages 3-5. Methods: Parents were recruited from a pediatric nephrology clinic and randomly assigned to one of two treatment groups: usual support for home-based clinical caregiving (control) or usual support plus password-protected access to OPIS for 20 weeks (intervention). Both groups completed study measures at study entry and exit. We assessed feasibility descriptively in terms of recruitment and retention rates overall; assessed recruitment, retention, and uptake of the intervention between groups; and compared family condition management, empowerment to deliver care, and fathers' involvement between groups. Results: We recruited 55 parents of 39 children (42\% of eligible families). Of those, about three-quarters of intervention group parents (19/26, 73\%) and control group parents (22/29, 76\%) were retained through completion of 20-week data collection. The overall retention rate was 41/55 (75\%). The 41 parents completing the trial were asked to respond to the same 10 questionnaire scales at both baseline and 20 weeks later; 10 scores were missing at baseline and nine were missing at 20 weeks. Site user statistics provided evidence that all intervention group parents accessed OPIS. Analysis found that intervention group parents showed a greater improvement in perceived competence to manage their child's condition compared to control group parents: adjusted mean Family Management Measure (FaMM) Condition Management Ability Scale intervention group 44.5 versus control group 41.9, difference 2.6, 95\% CI -1.6 to 6.7. Differences between the groups in the FaMM Family Life Difficulty Scale (39.9 vs 36.3, difference 3.7, 95\% CI -4.9 to 12.2) appeared to agree with a qualitative observation that OPIS helped parents achieve understanding and maintain awareness of the impact of their child's condition. Conclusions: A full-scale RCT of the effectiveness of OPIS is feasible. OPIS has the potential to beneficially affect self-reported outcomes, including parents' perceived competence to manage home-based clinical care for children with CKD stage 3-5. Our design and methodology can be transferred to the management of other childhood conditions. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 84283190; http://www.controlled-trials.com/ISRCTN84283190 (Archived by WebCite at http://www.webcitation.org/6TuPdrXTF). ",
doi="10.2196/resprot.3716",
url="http://www.researchprotocols.org/2014/4/e69/",
url="http://www.ncbi.nlm.nih.gov/pubmed/25472567"
}


@Article{info:doi/10.2196/resprot.3629,
author="Mori, Makiko
and Tajima, Miyuki
and Kimura, Risa
and Sasaki, Norio
and Somemura, Hironori
and Ito, Yukio
and Okanoya, June
and Yamamoto, Megumi
and Nakamura, Saki
and Tanaka, Katsutoshi",
title="A Web-Based Training Program Using Cognitive Behavioral Therapy to Alleviate Psychological Distress Among Employees: Randomized Controlled Pilot Trial",
journal="JMIR Res Protoc",
year="2014",
month="Dec",
day="02",
volume="3",
number="4",
pages="e70",
keywords="Web-based training program",
keywords="cognitive behavioral therapy",
keywords="stress management",
keywords="workplace",
keywords="Internet",
keywords="group",
abstract="Background: A number of psychoeducational programs based on cognitive behavioral therapy (CBT) to alleviate psychological distress have been developed for implementation in clinical settings. However, while these programs are considered critical components of stress management education in a workplace setting, they are required to be brief and simple to implement, which can hinder development. Objective: The intent of the study was to examine the effects of a brief training program based on CBT in alleviating psychological distress among employees and facilitating self-evaluation of stress management skills, including improving the ability to recognize dysfunctional thinking patterns, transform dysfunctional thoughts to functional ones, cope with stress, and solve problems. Methods: Of the 187 employees at an information technology company in Tokyo, Japan, 168 consented to participate in our non-blinded randomized controlled study. The training group received CBT group education by a qualified CBT expert and 1 month of follow-up Web-based CBT homework. The effects of this educational program on the psychological distress and stress management skills of employees were examined immediately after completion of training and then again after 6 months. Results: Although the training group did exhibit lower mean scores on the Kessler-6 (K6) scale for psychological distress after 6 months, the difference from the control group was not significant. However, the ability of training group participants to recognize dysfunctional thinking was significantly improved both immediately after training completion and after 6 months. While the ability of participants to cope with stress was not significantly improved immediately after training, improvement was noted after 6 months in the training group. No notable improvements were observed in the ability of participants to transform thoughts from dysfunctional to functional or in problem-solving skills. A sub-analysis of participants who initially exhibited clinically significant psychological distress (K6 score ?5) showed that the mean K6 score was significantly improved immediately after training completion for the training group compared to the control group (?2.50 vs ?0.07; mean difference 2.43, 95\% CI 0.55-4.31; d=0.61), with this effect remaining even after 6 months (?3.49 vs ?0.50; mean difference 2.99, 95\% CI 0.70-5.29; d=0.60). Conclusions: Our results suggest that a brief stress management program that combines group CBT education with Web-based CBT homework moderately alleviates the distress of employees with clinically significant psychological distress. In addition, the program might help improve employees' ability to evaluate their own stress management skills. ",
doi="10.2196/resprot.3629",
url="http://www.researchprotocols.org/2014/4/e70/",
url="http://www.ncbi.nlm.nih.gov/pubmed/25470499"
}


@Article{info:doi/10.2196/resprot.3013,
author="W{\'o}jcicki, R. Thomas
and Grigsby-Toussaint, Diana
and Hillman, H. Charles
and Huhman, Marian
and McAuley, Edward",
title="Promoting Physical Activity in Low-Active Adolescents via Facebook: A Pilot Randomized Controlled Trial to Test Feasibility",
journal="JMIR Res Protoc",
year="2014",
month="Oct",
day="30",
volume="3",
number="4",
pages="e56",
keywords="social media",
keywords="physical activity",
keywords="adolescents",
keywords="behavior change",
keywords="randomized controlled trial",
keywords="feasibility",
abstract="Background: The World Wide Web is an effective method for delivering health behavior programs, yet major limitations remain (eg, cost of development, time and resource requirements, limited interactivity). Social media, however, has the potential to deliver highly customizable and socially interactive behavioral interventions with fewer constraints. Thus, the evaluation of social media as a means to influence health behaviors is warranted. Objective: The objective of this trial was to examine and demonstrate the feasibility of using an established social networking platform (ie, Facebook) to deliver an 8 week physical activity intervention to a sample of low-active adolescents (N=21; estimated marginal mean age 13.48 years). Methods: Participants were randomized to either an experimental (ie, Behavioral) or attentional control (ie, Informational) condition. Both conditions received access to a restricted-access, study-specific Facebook group where the group's administrator made two daily wall posts containing youth-based physical activity information and resources. Primary outcomes included physical activity as assessed by accelerometry and self-report. Interactions and main effects were examined, as well as mean differences in effect sizes. Results: Analyses revealed significant improvements over time on subjectively reported weekly leisure-time physical activity (F1,18=8.426, P=.009, $\eta$2 = .319). However, there was no interaction between time and condition (F1,18=0.002, P=.968, $\eta$2 = .000). There were no significant time or interaction effects among the objectively measured physical activity variables. Examination of effect sizes revealed moderate-to-large changes in physical activity outcomes. Conclusions: Results provide initial support for the feasibility of delivery of a physical activity intervention to low-active adolescents via social media. Whether by employing behavioral interventions via social media can result in statistically meaningful changes in health-related behaviors and outcomes remains to be determined. Trial Registration: ClinicalTrials.gov NCT01870323; http://clinicaltrials.gov/show/NCT01870323 (Archived by WebCite at http://www.webcitation.org/6SUTmSeZZ). ",
doi="10.2196/resprot.3013",
url="http://www.researchprotocols.org/2014/4/e56/",
url="http://www.ncbi.nlm.nih.gov/pubmed/25357008"
}


@Article{info:doi/10.2196/resprot.3412,
author="Rosal, C. Milagros
and Heyden, Robin
and Mejilla, Roanne
and Capelson, Roberta
and Chalmers, A. Karen
and Rizzo DePaoli, Maria
and Veerappa, Chetty
and Wiecha, M. John",
title="A Virtual World Versus Face-to-Face Intervention Format to Promote Diabetes Self-Management Among African American Women: A Pilot Randomized Clinical Trial",
journal="JMIR Res Protoc",
year="2014",
month="Oct",
day="24",
volume="3",
number="4",
pages="e54",
keywords="African Americans",
keywords="clinical trials",
keywords="feasibility",
keywords="health behavior",
keywords="health disparities",
keywords="minority health",
keywords="technology",
keywords="type 2 diabetes",
keywords="virtual systems",
keywords="randomized clinical trial",
abstract="Background: Virtual world environments have the potential to increase access to diabetes self-management interventions and may lower cost. Objective: We tested the feasibility and comparative effectiveness of a virtual world versus a face-to-face diabetes self-management group intervention. Methods: We recruited African American women with type 2 diabetes to participate in an 8-week diabetes self-management program adapted from Power to Prevent, a behavior-change in-person group program for African Americans with diabetes or pre-diabetes. The program is social cognitive theory--guided, evidence-based, and culturally tailored. Participants were randomized to participate in the program via virtual world (Second Life) or face-to-face, both delivered by a single intervention team. Blinded assessors conducted in-person clinical (HbA1c), behavioral, and psychosocial measurements at baseline and 4-month follow-up. Pre-post differences within and between intervention groups were assessed using t tests and chi-square tests (two-sided and intention-to-treat analyses for all comparisons). Results: Participants (N=89) were an average of 52 years old (SD 10), 60\% had ?high school, 82\% had household incomes <US \$30,000, and computer experience was variable. Overall session attendance was similar across the groups (6.8/8 sessions, P=.90). Compared to face-to-face, virtual world was slightly superior for total activity, light activity, and inactivity (P=.05, P=.07, and P=.025, respectively). HbA1c reduction was significant within face-to-face (?0.46, P=02) but not within virtual world (?0.31, P=.19), although there were no significant between group differences in HbA1c (P=.52). In both groups, 14\% fewer patients had post-intervention HbA1c ?9\% (virtual world P=.014; face-to-face P=.002), with no significant between group difference (P=.493). Compared to virtual world, face-to-face was marginally superior for reducing depression symptoms (P=.051). The virtual world intervention costs were US \$1117 versus US \$931 for face-to-face. Conclusions: It is feasible to deliver diabetes self-management interventions to inner city African American women via virtual worlds, and outcomes may be comparable to those of face-to-face interventions. Further effectiveness research is warranted. Trial Registration: ClinicalTrials.gov NCT01340079; http://clinicaltrials.gov/show/NCT01340079 (Archived by WebCite at http://www.webcitation.org/6T2aSvmka). ",
doi="10.2196/resprot.3412",
url="http://www.researchprotocols.org/2014/4/e54/",
url="http://www.ncbi.nlm.nih.gov/pubmed/25344620"
}


@Article{info:doi/10.2196/resprot.3282,
author="Schwartz, Jennifer
and Bottorff, L. Joan
and Ratner, A. Pamela
and Gotay, Carolyn
and Johnson, C. Kenneth
and Memetovic, Jasmina
and Richardson, G. Chris",
title="Effect of Web-Based Messages on Girls' Knowledge and Risk Perceptions Related to Cigarette Smoke and Breast Cancer: 6-Month Follow-Up of a Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2014",
month="Sep",
day="30",
volume="3",
number="3",
pages="e53",
keywords="secondhand smoke",
keywords="breast cancer",
keywords="Web-based health promotion",
keywords="adolescents",
abstract="Background: Evidence indicating an association between cigarette smoke exposure and an increase in breast cancer risk highlights the need for health messages that aim to prevent smoking initiation and reduce secondhand smoke (SHS) exposure among adolescent girls. Objective: This study aimed to evaluate the efficacy of targeted gender-sensitive, breast cancer-specific, Web-based messages about the increased risk of breast cancer associated with cigarette smoke exposure. Outcomes assessed 6 months postmessage delivery included nonsmoking adolescent girls' knowledge of the link between cigarette smoke exposure and breast cancer, perceptions of breast cancer risk associated with cigarette smoke, smoking behavior and intentions, and stage of change related to avoidance of secondhand smoke. Methods: A prospective randomized controlled trial was used to compare standard (control) messages with targeted gender- and Aboriginal status-sensitive, breast cancer-specific (intervention) messages. Messages were delivered online to 618 nonsmoking girls, aged 13 to 15 years, clustered in 74 Canadian secondary schools. Results: Compared with the control group, girls in the intervention group were significantly more likely to report that breast cancer is an illness caused by cigarette smoke (adjusted relative risk [ARR] 1.33, 95\% CI 1.05-1.68) and to agree that exposure to SHS increases their risk of breast cancer (ARR 1.10, 95\% CI 1.02-1.20).  No significant effects were observed for a change in smoking status, intention to try smoking, or stage of change related to avoidance of SHS. Conclusions: Compared with standard messages, targeted gender-sensitive, breast cancer-specific messages had a stronger influence on girls' knowledge and perceived risk of cigarette smoke exposure as a risk factor for breast cancer.  Brief information-based interventions delivered over the Internet have the potential to provide effective health promotion that could be broadly disseminated and lead to long-term effects on girls' knowledge and risk perceptions about cigarette exposure and breast cancer. ",
doi="10.2196/resprot.3282",
url="http://www.researchprotocols.org/2014/3/e53/",
url="http://www.ncbi.nlm.nih.gov/pubmed/25271096"
}


@Article{info:doi/10.2196/resprot.2858,
author="Richardson, G. Chris
and Struik, L. Laura
and Johnson, C. Kenneth
and Ratner, A. Pamela
and Gotay, Carolyn
and Memetovic, Jasmina
and Okoli, T. Chizimuzo
and Bottorff, L. Joan",
title="Initial Impact of Tailored Web-Based Messages About Cigarette Smoke and Breast Cancer Risk on Boys' and Girls' Risk Perceptions and Information Seeking: Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2013",
month="Dec",
day="10",
volume="2",
number="2",
pages="e53",
keywords="breast cancer",
keywords="secondhand smoke",
keywords="cancer prevention",
keywords="youth",
keywords="gender",
abstract="Background: Recent evidence indicates a causal link between both active smoking and secondhand smoke (SHS) exposure and breast cancer (BC). Objective: The objective of the present study was to evaluate the initial reactions of girls and boys to tailored Web-based messages that describe the relationship between SHS and BC, using a parallel, single-blinded cluster randomized controlled trial. Methods: This trial was nested within a cycle of an ongoing longitudinal study of 1498 students from 74 secondary schools. Self-reported assessments were used to evaluate the impact of study messages on participants' risk perception and interest in obtaining additional information after participants were randomized by schools to control or intervention groups. The intervention group received a tailored visual message (based on gender and Aboriginal status) about BC and tobacco smoke. The control group received a standard visual message about smoking and cancer. Results: SHS exposure was identified as a BC risk factor by 380/1488 (25.54\%) participants, during the preintervention analysis. Compared to the female participants in the control group (491/839, 58.5\%), girls who received the intervention (339/649, 52.2\%) were 14\% more likely to agree that exposure to SHS increased their BC risk (relative risk [RR] 1.14, 95\% CI 1.07-1.21). Nonsmoking girls who received the intervention were 14\% more likely to agree that starting smoking would increase their BC risk (RR 1.14, 95\% CI 1.07-1.21). Compared to the male participants in control group (348/839, 41.5\%), boys who received the intervention (310/649, 47.8\%) were 10\% more likely to agree that girls' exposure to SHS increased their BC risk (RR 1.10, 95\% CI 1.02-1.18). Compared to controls, girls who received the intervention were 52\% more likely to request additional information about SHS and BC (RR 1.52, 95\% CI 1.12-2.06). Conclusions: Brief gender-sensitive messages delivered via the Internet have the potential to increase awareness and to stimulate information seeking about the risk for BC associated with SHS. ",
doi="10.2196/resprot.2858",
url="http://www.researchprotocols.org/2013/2/e53/",
url="http://www.ncbi.nlm.nih.gov/pubmed/24326101"
}