The primary objective is to assess the safety and efficacy of the Early@home telemedicine system that relocates hospital care for patients recovering of COVID-19 to the home situation. The secondary objective is to assess the impact of this…
ID
Source
Brief title
Condition
- Viral infectious disorders
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the difference in number of days alive at home, 30 days
from randomization.
Secondary outcome
Secondary endpoints are the difference in mortality, hospital length of stay,
readmission to the hospital and to the ICU, number of unplanned visits to the
hospital and number of visits to the general practitioner, and Hospital Anxiety
and Depression Scale score after randomization and at discharge.
Background summary
The large number of hospital admissions for COVID-19 puts a significant strain
on patients and hospital organizations alike. Patients experience more
depression and anxiety due to hospital admission in contact isolation. Hospital
organizations have to ensure enough available hospital beds for those in need,
which has proven to be challenging during surges of SARS-CoV-2 infections.
Relocating hospital care to the home situation, assisted by telemonitoring,
might improve the number of days at home for patients recovering of COVID-19
without compromising patient safety.
Study objective
The primary objective is to assess the safety and efficacy of the Early@home
telemedicine system that relocates hospital care for patients recovering of
COVID-19 to the home situation. The secondary objective is to assess the impact
of this intervention on the psychological wellbeing of patients.
Study design
Early@home is an open, randomized, controlled trial. Patients will be
randomized 1:1 to either the intervention group or the group receiving care as
usual.
Intervention
The intervention will consist of relocated hospital care, possibly with oxygen
therapy at home. Patients will fill out a questionnaire three times a day using
a mobile telephone application designed for telemonitoring. The questionnaire
consists of three symptoms, temperature and oxygen saturation. A monitor team,
under supervision of a medical specialist, will contact each patient daily to
discuss the measurements and adapt treatment if necessary.
Study burden and risks
Secondary endpoints are:
- Mortality, in hospital and 30 days after randomization
- COVID-19 specific mortality, in hospital and 30 days after randomization
- Total hospital length of stay
- Number of ED visits or unplanned outpatient clinic visits 30 days after
randomization
- Number of general practitioner visits 30 days after randomization
- Number of hospital readmissions
- Number of intensive care unit readmissions
For optimal analysis and interpretations of the results, the following
additional parameters will be collected:
Patient characteristics: age, gender, comorbidities, smoking status, clinical
frailty scale at first hospital admission.
Admission details: admission date, highest amount of oxygen delivered (L/min),
ICU admission, dexamethasone administration
Occurrence of adverse events during admission: e.g. pulmonary embolism, other
thromboembolism, bacterial superinfection, sepsis, decompensatio cordis.
Intervention details: number of days of relocated hospital care, reason for ED
visit, reason for readmission at COVID-19 unit, reason for readmission to other
unit.
App data: measurements, symptoms and contact moments filled out in the app.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
- The patient is admitted to the hospital with COVID-19 pneumonia;
- The patient is recovering;
- The patient is expected to be discharged home;
- A partner/primary caregiver is available at the patients home for support;
- A rectal thermometer is available;
- The patient is in possession of a smartphone with the ability to host the
Luscii app (iOS or Android);
- The patient or the caregiver is able to use the smartphone and Luscii app;
- The patient or the caregiver is able to use the pulse oximeter;
- The patient or the caregiver is able to speak, read and understand the Dutch
language sufficiently enough to be able to use the Luscii app;
Exclusion criteria
- A patient with dementia or severe psychiatric disorder who is unlikely to be
compliant to the intervention (to be determined by treating physician);
- A patient who is discharged to a care facility or rehabilitation center;
- A patient who needs more medical support than the caregivers or CaHS can
manage.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL76011.041.20 |