Early@home

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.

Relocated hospital care with telemedicine will improve the number of days alive at home for patients with COVID-19

T0= randomization, T30= 30 days after randomization. All other timepoints depend on the situation.

Relocated hospital care with telemedicine