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

NCT04488562 | Completed

• 1 other identifier: MEC-2020-0318
• Study Type: observational
• Target: 133
• Locations: 1 country
• Sites: 3

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.

Conditions

COVID-19; Pulmonary Fibrosis

Keywords

Home monitoring

Outcome Measures

Primary Outcomes (44)

• VAS

  Visual Analogue Scale: scores on fatigue, dyspnea, cough and general wellbeing on a scale ranging from 0-10. Higher score indicates more complaint.

  3 months

• VAS

  Visual Analogue Scale: scores on fatigue, dyspnea, cough and general wellbeing on a scale ranging from 0-10. Higher score indicates more complaint.

  6 months

• VAS

  Visual Analogue Scale: scores on fatigue, dyspnea, cough and general wellbeing on a scale ranging from 0-10. Higher score indicates more complaint.

  12 months

• Temperature

  Body temperature measured with an thermometer

  3 months

• Oxygen measurements

  Oxygen saturation measured with an pulse oximeter

  3 months

• Oxygen measurements

  Oxygen saturation measured with an pulse oximeter

  6 months

• Oxygen measurements

  Oxygen saturation measured with an pulse oximeter

  12 months

• Forced Vital Capacity (FVC) home spirometry in %

  FVC change measured with home spirometry at 3 months (in %)

  3 months

• Forced Vital Capacity (FVC) home spirometry in L

  FVC change measured with home spirometry at 3 months (in L)

  3 months

• Forced Vital Capacity (FVC) home spirometry in %

  FVC change measured with home spirometry at 6 months (in %)

  6 months

• Forced Vital Capacity (FVC) home spirometry in L

  FVC change measured with home spirometry at 6 months (in L)

  6 months

• Forced Vital Capacity (FVC) home spirometry in L

  FVC change measured with home spirometry at 12 months (in L)

  12 months

• Forced Vital Capacity (FVC) home spirometry in %

  FVC change measured with home spirometry at 12 months (in %)

  12 months

• Forced Vital Capacity (FVC) hospital spirometry in %

  FVC change measured with hospital spirometry and saturation at 3 months (in %)

  3 months

• Forced Vital Capacity (FVC) hospital spirometry in L

  FVC change measured with hospital spirometry and saturation at 3 months (in L)

  3 months

• Forced Vital Capacity (FVC) hospital spirometry in %

  FVC change measured with hospital spirometry and saturation at 6 months (in %)

  6 months

• Forced Vital Capacity (FVC) hospital spirometry in L

  FVC change measured with hospital spirometry and saturation at 6 months (in L)

  6 months

• Forced Vital Capacity (FVC) hospital spirometry in %

  FVC change measured with hospital spirometry and saturation at 12 months (in %)

  12 months

• Forced Vital Capacity (FVC) hospital spirometry in L

  FVC change measured with hospital spirometry and saturation at 12 months (in L)

  12 months

• Adherence to weekly home spirometry

  The percentage of patients completed weekly home spirometry

  1 year after inclusion

• EQ5D

  The EuroQol five dimensions 5-level questionnaire: 6-item questionnaire on five dimensions: The EuroQol five dimensions 5-level questionnaire is a standardized instrument to measures health outcomes in two components: health description and valuation. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Higher score indicates a poorer health status

  Baseline

• EQ5D

  The EuroQol five dimensions 5-level questionnaire: 6-item questionnaire on five dimensions: The EuroQol five dimensions 5-level questionnaire is a standardized instrument to measures health outcomes in two components: health description and valuation. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Higher score indicates a poorer health status

  6 weeks

• EQ5D

  The EuroQol five dimensions 5-level questionnaire: 6-item questionnaire on five dimensions: The EuroQol five dimensions 5-level questionnaire is a standardized instrument to measures health outcomes in two components: health description and valuation. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Higher score indicates a poorer health status

  3 months

• EQ5D

  The EuroQol five dimensions 5-level questionnaire: 6-item questionnaire on five dimensions: The EuroQol five dimensions 5-level questionnaire is a standardized instrument to measures health outcomes in two components: health description and valuation. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Higher score indicates a poorer health status

  6 months

• EQ5D

  The EuroQol five dimensions 5-level questionnaire: 6-item questionnaire on five dimensions: The EuroQol five dimensions 5-level questionnaire is a standardized instrument to measures health outcomes in two components: health description and valuation. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Higher score indicates a poorer health status

  9 months

• EQ5D

  The EuroQol five dimensions 5-level questionnaire: 6-item questionnaire on five dimensions: The EuroQol five dimensions 5-level questionnaire is a standardized instrument to measures health outcomes in two components: health description and valuation. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Higher score indicates a poorer health status

  12 months

• FAS

  Fatigue Assessment Scale: 10-item questionnaire about fatigue FAS. The fatigue assessment scale (FAS) is a 10-item self-administered questionnaire about fatigue in patients with sarcoidosis. The score ranges from 5-50 points, with a score of ≥ 22 points as cut-off for fatigue. The minimal important difference (MID) is 4 points or a 10% lower score. It will take about 1-2 minutes to complete.

  Baseline

• FAS

  Fatigue Assessment Scale: 10-item questionnaire about fatigue FAS. The fatigue assessment scale (FAS) is a 10-item self-administered questionnaire about fatigue in patients with sarcoidosis. The score ranges from 5-50 points, with a score of ≥ 22 points as cut-off for fatigue. The minimal important difference (MID) is 4 points or a 10% lower score. It will take about 1-2 minutes to complete.

  6 weeks

• FAS

  Fatigue Assessment Scale: 10-item questionnaire about fatigue FAS. The fatigue assessment scale (FAS) is a 10-item self-administered questionnaire about fatigue in patients with sarcoidosis. The score ranges from 5-50 points, with a score of ≥ 22 points as cut-off for fatigue. The minimal important difference (MID) is 4 points or a 10% lower score. It will take about 1-2 minutes to complete.

  3 months weeks

• FAS

  Fatigue Assessment Scale: 10-item questionnaire about fatigue FAS. The fatigue assessment scale (FAS) is a 10-item self-administered questionnaire about fatigue in patients with sarcoidosis. The score ranges from 5-50 points, with a score of ≥ 22 points as cut-off for fatigue. The minimal important difference (MID) is 4 points or a 10% lower score. It will take about 1-2 minutes to complete.

  6 months weeks

• FAS

  Fatigue Assessment Scale: 10-item questionnaire about fatigue FAS. The fatigue assessment scale (FAS) is a 10-item self-administered questionnaire about fatigue in patients with sarcoidosis. The score ranges from 5-50 points, with a score of ≥ 22 points as cut-off for fatigue. The minimal important difference (MID) is 4 points or a 10% lower score. It will take about 1-2 minutes to complete.

  9 months weeks

• FAS

  Fatigue Assessment Scale: 10-item questionnaire about fatigue FAS. The fatigue assessment scale (FAS) is a 10-item self-administered questionnaire about fatigue in patients with sarcoidosis. The score ranges from 5-50 points, with a score of ≥ 22 points as cut-off for fatigue. The minimal important difference (MID) is 4 points or a 10% lower score. It will take about 1-2 minutes to complete.

  12 months weeks

• GRoC

  Global Rating of Change Scales: Global rating of change (GRC) scales provide a method of obtaining information about improving or deteriorated of health condition of patients over time. Patients are asked to make global ratings on changes in regards to their well-being on a 15-point self-report scale (from -7 to 7 ). It will take about 1 minute to complete. Higher score indicates a better health condition.

  Baseline

• GRoC

  Global Rating of Change Scales: Global rating of change (GRC) scales provide a method of obtaining information about improving or deteriorated of health condition of patients over time. Patients are asked to make global ratings on changes in regards to their well-being on a 15-point self-report scale (from -7 to 7 ). It will take about 1 minute to complete. Higher score indicates a better health condition.

  6 weeks

• GRoC

  Global Rating of Change Scales: Global rating of change (GRC) scales provide a method of obtaining information about improving or deteriorated of health condition of patients over time. Patients are asked to make global ratings on changes in regards to their well-being on a 15-point self-report scale (from -7 to 7 ). It will take about 1 minute to complete. Higher score indicates a better health condition.

  3 months

• GRoC

  Global Rating of Change Scales: Global rating of change (GRC) scales provide a method of obtaining information about improving or deteriorated of health condition of patients over time. Patients are asked to make global ratings on changes in regards to their well-being on a 15-point self-report scale (from -7 to 7 ). It will take about 1 minute to complete. Higher score indicates a better health condition.

  6 months

• GRoC

  Global Rating of Change Scales: Global rating of change (GRC) scales provide a method of obtaining information about improving or deteriorated of health condition of patients over time. Patients are asked to make global ratings on changes in regards to their well-being on a 15-point self-report scale (from -7 to 7 ). It will take about 1 minute to complete. Higher score indicates a better health condition.

  9 months

• GRoC

  Global Rating of Change Scales: Global rating of change (GRC) scales provide a method of obtaining information about improving or deteriorated of health condition of patients over time. Patients are asked to make global ratings on changes in regards to their well-being on a 15-point self-report scale (from -7 to 7 ). It will take about 1 minute to complete. Higher score indicates a better health condition.

  12 months

• ABC tool

  Questionnaire consisting of five domains: symptoms, functional state, mental state, emotions and fatigue, smoking status, exacerbations, dyspnoea, body mass index, lung function and self-reported physical activity. Outcomes are visualized using coloured balloons. green balloons indicate a satisfactory score, red balloons a low score and orange balloons an intermediate score. Grey balloons represent the balloons of previous visits.

  Baseline

• ABC tool

  Questionnaire consisting of five domains: symptoms, functional state, mental state, emotions and fatigue, smoking status, exacerbations, dyspnoea, body mass index, lung function and self-reported physical activity. Outcomes are visualized using coloured balloons. green balloons indicate a satisfactory score, red balloons a low score and orange balloons an intermediate score. Grey balloons represent the balloons of previous visits.

  6 weeks

• ABC tool

  Questionnaire consisting of five domains: symptoms, functional state, mental state, emotions and fatigue, smoking status, exacerbations, dyspnoea, body mass index, lung function and self-reported physical activity. Outcomes are visualized using coloured balloons. green balloons indicate a satisfactory score, red balloons a low score and orange balloons an intermediate score. Grey balloons represent the balloons of previous visits.

  3 months

• ABC tool

  Questionnaire consisting of five domains: symptoms, functional state, mental state, emotions and fatigue, smoking status, exacerbations, dyspnoea, body mass index, lung function and self-reported physical activity. Outcomes are visualized using coloured balloons. green balloons indicate a satisfactory score, red balloons a low score and orange balloons an intermediate score. Grey balloons represent the balloons of previous visits.

  6 months

• ABC tool

  Questionnaire consisting of five domains: symptoms, functional state, mental state, emotions and fatigue, smoking status, exacerbations, dyspnoea, body mass index, lung function and self-reported physical activity. Outcomes are visualized using coloured balloons. green balloons indicate a satisfactory score, red balloons a low score and orange balloons an intermediate score. Grey balloons represent the balloons of previous visits.

  9 months

• ABC tool

  Questionnaire consisting of five domains: symptoms, functional state, mental state, emotions and fatigue, smoking status, exacerbations, dyspnoea, body mass index, lung function and self-reported physical activity. Outcomes are visualized using coloured balloons. green balloons indicate a satisfactory score, red balloons a low score and orange balloons an intermediate score. Grey balloons represent the balloons of previous visits.

  12 months

Secondary Outcomes (5)

• Correlation between FVC, HRCT patterns, symptoms and quality of life

  3 months

• Correlation between FVC, HRCT patterns, symptoms and quality of life

  6 months

• Correlation between FVC, HRCT patterns, symptoms and quality of life

  12 months

• Predictors for the course of recovery of COVID-19 infection after hospital admission

  12 months

• Satisfaction of patients and caregivers with the use of a home monitoring system

  12 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients admitted to the hospital with proven COVID-19 infection
• Abnormalities on Chest X-ray/HRCT due to COVID-19 infection

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Leiden University Medical Center: collaborator
• Amsterdam UMC, location VUmc: collaborator
• Dutch Society of Physicians for Pulmonology and Tuberculosis: collaborator

Study Sites (3)

Amsterdam University Center - location VUmc

Amsterdam, 1081 HV, Netherlands

Location

Leiden University Medical Center

Leiden, 2333 ZA, Netherlands

Location

Erasmus MC

Rotterdam, 3015 CD, Netherlands

Location

MeSH Terms

Conditions

COVID-19; Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Interstitial; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• M.S. Wijsenbeek, dr

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: July 28, 2020
• Study Start: March 19, 2020
• Primary Completion: August 26, 2021
• Study Completion: February 26, 2022
• Last Updated: February 15, 2023

Record last verified: 2023-02

Locations

NL (3)