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Completed

NCT Number: NCT04488562

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Fibrosis Infections Lung Diseases Lung Diseases, Interstitial Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Pulmonary Fibrosis RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Amsterdam University Center - location VUmc, Amsterdam, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. VAS

    Time frame: 3 months

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

  2. VAS

    Time frame: 6 months

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

  3. VAS

    Time frame: 12 months

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

  4. Temperature

    Time frame: 3 months

    Body temperature measured with an thermometer

  5. Oxygen measurements

    Time frame: 3 months

    Oxygen saturation measured with an pulse oximeter

  6. Oxygen measurements

    Time frame: 6 months

    Oxygen saturation measured with an pulse oximeter

  7. Oxygen measurements

    Time frame: 12 months

    Oxygen saturation measured with an pulse oximeter

  8. Forced Vital Capacity (FVC) home spirometry in %

    Time frame: 3 months

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

  9. Forced Vital Capacity (FVC) home spirometry in L

    Time frame: 3 months

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

  10. Forced Vital Capacity (FVC) home spirometry in %

    Time frame: 6 months

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

  11. Forced Vital Capacity (FVC) home spirometry in L

    Time frame: 6 months

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

  12. Forced Vital Capacity (FVC) home spirometry in L

    Time frame: 12 months

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

  13. Forced Vital Capacity (FVC) home spirometry in %

    Time frame: 12 months

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

  14. Forced Vital Capacity (FVC) hospital spirometry in %

    Time frame: 3 months

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

  15. Forced Vital Capacity (FVC) hospital spirometry in L

    Time frame: 3 months

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

  16. Forced Vital Capacity (FVC) hospital spirometry in %

    Time frame: 6 months

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

  17. Forced Vital Capacity (FVC) hospital spirometry in L

    Time frame: 6 months

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

  18. Forced Vital Capacity (FVC) hospital spirometry in %

    Time frame: 12 months

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

  19. Forced Vital Capacity (FVC) hospital spirometry in L

    Time frame: 12 months

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

  20. Adherence to weekly home spirometry

    Time frame: 1 year after inclusion

    The percentage of patients completed weekly home spirometry

  21. EQ5D

    Time frame: Baseline

    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

  22. EQ5D

    Time frame: 6 weeks

    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

  23. EQ5D

    Time frame: 3 months

    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

  24. EQ5D

    Time frame: 6 months

    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

  25. EQ5D

    Time frame: 9 months

    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

  26. EQ5D

    Time frame: 12 months

    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

  27. FAS

    Time frame: Baseline

    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.

  28. FAS

    Time frame: 6 weeks

    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.

  29. FAS

    Time frame: 3 months weeks

    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.

  30. FAS

    Time frame: 6 months weeks

    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.

  31. FAS

    Time frame: 9 months weeks

    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.

  32. FAS

    Time frame: 12 months weeks

    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.

  33. GRoC

    Time frame: Baseline

    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.

  34. GRoC

    Time frame: 6 weeks

    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.

  35. GRoC

    Time frame: 3 months

    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.

  36. GRoC

    Time frame: 6 months

    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.

  37. GRoC

    Time frame: 9 months

    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.

  38. GRoC

    Time frame: 12 months

    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.

  39. ABC tool

    Time frame: Baseline

    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.

  40. ABC tool

    Time frame: 6 weeks

    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.

  41. ABC tool

    Time frame: 3 months

    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.

  42. ABC tool

    Time frame: 6 months

    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.

  43. ABC tool

    Time frame: 9 months

    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.

  44. ABC tool

    Time frame: 12 months

    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.

Secondary outcomes

  1. Correlation between FVC, HRCT patterns, symptoms and quality of life

    Time frame: 3 months

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

  2. Correlation between FVC, HRCT patterns, symptoms and quality of life

    Time frame: 6 months

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

  3. Correlation between FVC, HRCT patterns, symptoms and quality of life

    Time frame: 12 months

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

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

    Time frame: 12 months

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

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

    Time frame: 12 months

    Healthcare provider and patient satisfaction and experience with the online application. Patients and healthcare providers are asked about their experiences and opinions on homemonitoring.

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

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

Registry information

Acronym: HOMECOMIN'

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jul 28, 2020
Registry last updated
Feb 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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