Official Title
Home Monitoring and Evaluation After Admission for COVID-19 in the Netherlands
Brief 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.

Detailed 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.

Completed
COVID-19
Pulmonary Fibrosis
Eligibility Criteria

Inclusion Criteria:

- Patients admitted to the hospital with proven COVID-19 infection

- Abnormalities on Chest X-ray/HRCT due to COVID-19 infection

Exclusion Criteria:

- Not able to speak, read or write in the native language of the country where the
patient is included

- Not able to comply to the study protocol, according to the judgement of the
investigator and/or patient

- No access to internet

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Netherlands
Locations

Amsterdam University Center - location VUmc
Amsterdam, Netherlands

Leiden University Medical Center
Leiden, Netherlands

Erasmus MC
Rotterdam, Netherlands

M.S. Wijsenbeek, dr, Principal Investigator
Erasmus Medical Center

Erasmus Medical Center
NCT Number
Keywords
Home monitoring
MeSH Terms
COVID-19
Pulmonary Fibrosis