No registrations found.
ID
Source
Brief title
Health condition
COVID-19
Sponsors and support
Intervention
Outcome measures
Primary outcome
Days alive at home 30 days after randomization
Secondary outcome
- 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
- Score for physchological wellbeing at start and discharge
Background summary
Rationale: 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 telemedicine, might improve the number of days at home for patients recovering of COVID-19 without compromising patient safety.
Objective: The primary objective is to assess the safety and efficacy of the “Early@home” telemedicine system that relocates hospital care for COVID-19 patients 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.
Study population: The study population will consist of patients who are admitted to the hospital with COVID-19, who are in the recovering phase of disease and who are expected to be discharged home.
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.
Main study parameters/endpoints: The primary endpoint is the difference in number of days alive at home, 30 days from randomization. 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.
Study objective
Relocated hospital care with telemedicine will improve the number of days alive at home for patients with COVID-19
Study design
T0= randomization, T30= 30 days after randomization. All other timepoints depend on the situation.
Intervention
Relocated hospital care with telemedicine
Inclusion criteria
- The patient is in the recovery phase of COVID-19 and receives low flow oxygen therapy or no oxygen therapy
- The patient is 18 years of age or older;
- The patient is admitted to the hospital with COVID-19 pneumonia;
- 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;
- 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 can be organized at home.
Design
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL9081 |
| Other | METC UMCU : 20-783 |