Clinical trial NCT04488562: Home Monitoring and Evaluation After Admission for COVID-19 in the Netherlands
Official title: Home Monitoring and Evaluation After Admission for COVID-19 in the Netherlands
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Pulmonary Fibrosis
Keywords: Home monitoring
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Leiden University Medical Center
name: Amsterdam UMC, location VUmc
name: Dutch Society of Physicians for Pulmonology and Tuberculosis
First posted: 2020-07-28
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 150 patients admitted at the Erasmus Medical Center, Leiden University Medical Center and the Amsterdam University Medical Center, location VUMC, with proven COVID-19 infection and abnormalities on Chest X-ray/HRCT due to COVID-19 infection.

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.

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

Primary outcomes:
measure: VAS
timeFrame: 3 months
measure: VAS
timeFrame: 6 months
measure: VAS
timeFrame: 12 months
measure: Temperature
timeFrame: 3 months
measure: Oxygen measurements
timeFrame: 3 months
measure: Oxygen measurements
timeFrame: 6 months
measure: Oxygen measurements
timeFrame: 12 months
measure: Forced Vital Capacity (FVC) home spirometry in %
timeFrame: 3 months
measure: Forced Vital Capacity (FVC) home spirometry in L
timeFrame: 3 months
measure: Forced Vital Capacity (FVC) home spirometry in %
timeFrame: 6 months
measure: Forced Vital Capacity (FVC) home spirometry in L
timeFrame: 6 months
measure: Forced Vital Capacity (FVC) home spirometry in L
timeFrame: 12 months
measure: Forced Vital Capacity (FVC) home spirometry in %
timeFrame: 12 months
measure: Forced Vital Capacity (FVC) hospital spirometry in %
timeFrame: 3 months
measure: Forced Vital Capacity (FVC) hospital spirometry in L
timeFrame: 3 months
measure: Forced Vital Capacity (FVC) hospital spirometry in %
timeFrame: 6 months
measure: Forced Vital Capacity (FVC) hospital spirometry in L
timeFrame: 6 months
measure: Forced Vital Capacity (FVC) hospital spirometry in %
timeFrame: 12 months
measure: Forced Vital Capacity (FVC) hospital spirometry in L
timeFrame: 12 months
measure: Adherence to weekly home spirometry
timeFrame: 1 year after inclusion
measure: EQ5D
timeFrame: Baseline
measure: EQ5D
timeFrame: 6 weeks
measure: EQ5D
timeFrame: 3 months
measure: EQ5D
timeFrame: 6 months
measure: EQ5D
timeFrame: 9 months
measure: EQ5D
timeFrame: 12 months
measure: FAS
timeFrame: Baseline
measure: FAS
timeFrame: 6 weeks
measure: FAS
timeFrame: 3 months weeks
measure: FAS
timeFrame: 6 months weeks
measure: FAS
timeFrame: 9 months weeks
measure: FAS
timeFrame: 12 months weeks
measure: GRoC
timeFrame: Baseline
measure: GRoC
timeFrame: 6 weeks
measure: GRoC
timeFrame: 3 months
measure: GRoC
timeFrame: 6 months
measure: GRoC
timeFrame: 9 months
measure: GRoC
timeFrame: 12 months
measure: ABC tool
timeFrame: Baseline
measure: ABC tool
timeFrame: 6 weeks
measure: ABC tool
timeFrame: 3 months
measure: ABC tool
timeFrame: 6 months
measure: ABC tool
timeFrame: 9 months
measure: ABC tool
timeFrame: 12 months
Secondary outcomes:
measure: Correlation between FVC, HRCT patterns, symptoms and quality of life
timeFrame: 3 months
measure: Correlation between FVC, HRCT patterns, symptoms and quality of life
timeFrame: 6 months
measure: Correlation between FVC, HRCT patterns, symptoms and quality of life
timeFrame: 12 months
measure: Predictors for the course of recovery of COVID-19 infection after hospital admission
timeFrame: 12 months
measure: Satisfaction of patients and caregivers with the use of a home monitoring system
timeFrame: 12 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam University Center - location VUmc
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus MC
Study officials:
affiliation: Erasmus Medical Center
name: M.S. Wijsenbeek, dr
role: PRINCIPAL_INVESTIGATOR
References: