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

NCT ID: NCT04488562

Last Updated: 2023-02-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 133 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-19
• Study Completion Date: 2022-02-26

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.

Conditions

COVID-19; Pulmonary Fibrosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with COVID-19

Patients with proven COVID-19 and abnormalities on chest X-Ray/HRCT, admitted at the hospital. Patients are included around the time of discharge from the hospital or at their regular outpatient clinic visit 6 weeks after discharge, depending on the clinical status of the patient at time of discharge.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Leiden University Medical Center

OTHER

Sponsor Role: collaborator

Amsterdam UMC, location VUmc

OTHER

Sponsor Role: collaborator

Dutch Society of Physicians for Pulmonology and Tuberculosis

OTHER

Sponsor Role: collaborator

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Marlies Wijsenbeek

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

M.S. Wijsenbeek, dr

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

Amsterdam University Center - location VUmc

Amsterdam, , Netherlands

Leiden University Medical Center

Leiden, , Netherlands

Erasmus MC

Rotterdam, , Netherlands

Countries

Netherlands

Other Identifiers

MEC-2020-0318

Identifier Type: -

Identifier Source: org_study_id