Home Monitoring and Evaluation After Admission for COVID-19 in the Netherlands — HOMECOMIN'  

COVID-19 Clinical Trial

Official title: Home Monitoring and Evaluation After Admission for COVID-19 in the Netherlands

Status Completed

Clinical Trial Summary

To date, little is known about the short and long-term complications of COVID-19. In order to obtain more insights in disease course and recovery of COVID-19 and to improve care after hospital admission, patients with COVID-19 will be monitored at home using an online home monitoring program for a period of 1 year.

Clinical Trial Description

Patients with COVID-19 have a variable disease course and recovery. After the SARS coronavirus outbreak in 2003, many patients developed pulmonary fibrosis. Emerging data from the COVID-19 outbreak suggests that a substantial number of patient will likely develop pulmonary fibrosis. However, much is still unknown (e.g. the percentage of patients who develop pulmonary fibrosis, progression of fibrosis). Since we have little knowledge on the disease course and long-term complications of COVID-19, it is very important to properly monitor patients after hospital admission. An online home monitoring program could be an efficient way to monitor disease course of COVID-19 and provide insights in the long-term effects of COVID-19.

In this prospective, observational multi center study we aim to include 150 patients that were admitted in the hospital with abnormalities on chest X-ray/HRCT due to COVID-19. Based on their clinical status, patients will be either included at time of discharge from the hospital or at time of their regular outpatient clinic visit, 6 weeks after discharge from the hospital. Patients will be monitored for a period of 1 year after admission, after signing informed consent. Home monitoring, consisting of real-time lung function measures and PROMs, has been developed and validated for patients with pulmonary fibrosis; home monitoring was feasible, FVC measurements were reliable and patient satisfaction was high.

Patients are asked to fill in a diary once weekly (consisting of Visual Analogue Scales on cough, dyspnea, fatigue, general well-being, and temperature and oxygen measurements) and measure their lung function (FVC) at home every week with a home spirometer (Spirobank Smart, MIR, Italy) (duration + -2 min). The spirometer is connected via Bluetooth with the secured app and results can be sent directly to the study team. Patients are instructed to contact the hospital using a secured eConsult if they have worsening complaints and/or have a decrease in saturation or lung function.

Patients are asked to fill complete short validated questionnaires (ABC tool, EQ5D-5L, Fatigue Assessment Scale and Global rating of change, duration + - 10 minutes) in the app, at time of discharge, 6 weeks, 3 months, 6 months, 9 months and 12 months after discharge.

Demographic data, clinical characteristics, lung function results, radiology data and data about medication will be collected from the electronic patient file during regular outpatient clinic visits. ;

Related Conditions & MeSH terms

• COVID-19
• Pulmonary Fibrosis

• NCT number: NCT04488562
• Study type: Observational [Patient Registry]
• Source: Erasmus Medical Center
• Status: Completed
• Start date: March 19, 2020
• Completion date: February 26, 2022