<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04488562</url>
  </required_header>
  <id_info>
    <org_study_id>MEC-2020-0318</org_study_id>
    <nct_id>NCT04488562</nct_id>
  </id_info>
  <brief_title>Home Monitoring and Evaluation After Admission for COVID-19 in the Netherlands</brief_title>
  <acronym>HOMECOMIN'</acronym>
  <official_title>Home Monitoring and Evaluation After Admission for COVID-19 in the Netherlands</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Erasmus Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Leiden University Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Amsterdam UMC, location VUmc</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dutch Society of Physicians for Pulmonology and Tuberculosis</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Erasmus Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To date, little is known about the short and long-term complications of COVID-19. In order to&#xD;
      obtain more insights in disease course and recovery of COVID-19 and to improve care after&#xD;
      hospital admission, patients with COVID-19 will be monitored at home using an online home&#xD;
      monitoring program for a period of 1 year.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with COVID-19 have a variable disease course and recovery. After the SARS&#xD;
      coronavirus outbreak in 2003, many patients developed pulmonary fibrosis. Emerging data from&#xD;
      the COVID-19 outbreak suggests that a substantial number of patient will likely develop&#xD;
      pulmonary fibrosis. However, much is still unknown (e.g. the percentage of patients who&#xD;
      develop pulmonary fibrosis, progression of fibrosis). Since we have little knowledge on the&#xD;
      disease course and long-term complications of COVID-19, it is very important to properly&#xD;
      monitor patients after hospital admission. An online home monitoring program could be an&#xD;
      efficient way to monitor disease course of COVID-19 and provide insights in the long-term&#xD;
      effects of COVID-19.&#xD;
&#xD;
      In this prospective, observational multi center study we aim to include 150 patients that&#xD;
      were admitted in the hospital with abnormalities on chest X-ray/HRCT due to COVID-19. Based&#xD;
      on their clinical status, patients will be either included at time of discharge from the&#xD;
      hospital or at time of their regular outpatient clinic visit, 6 weeks after discharge from&#xD;
      the hospital. Patients will be monitored for a period of 1 year after admission, after&#xD;
      signing informed consent. Home monitoring, consisting of real-time lung function measures and&#xD;
      PROMs, has been developed and validated for patients with pulmonary fibrosis; home monitoring&#xD;
      was feasible, FVC measurements were reliable and patient satisfaction was high.&#xD;
&#xD;
      Patients are asked to fill in a diary once weekly (consisting of Visual Analogue Scales on&#xD;
      cough, dyspnea, fatigue, general well-being, and temperature and oxygen measurements) and&#xD;
      measure their lung function (FVC) at home every week with a home spirometer (Spirobank Smart,&#xD;
      MIR, Italy) (duration + -2 min). The spirometer is connected via Bluetooth with the secured&#xD;
      app and results can be sent directly to the study team. Patients are instructed to contact&#xD;
      the hospital using a secured eConsult if they have worsening complaints and/or have a&#xD;
      decrease in saturation or lung function.&#xD;
&#xD;
      Patients are asked to fill complete short validated questionnaires (ABC tool, EQ5D-5L,&#xD;
      Fatigue Assessment Scale and Global rating of change, duration + - 10 minutes) in the app, at&#xD;
      time of discharge, 6 weeks, 3 months, 6 months, 9 months and 12 months after discharge.&#xD;
&#xD;
      Demographic data, clinical characteristics, lung function results, radiology data and data&#xD;
      about medication will be collected from the electronic patient file during regular outpatient&#xD;
      clinic visits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 19, 2020</start_date>
  <completion_date type="Actual">February 26, 2022</completion_date>
  <primary_completion_date type="Actual">August 26, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>VAS</measure>
    <time_frame>3 months</time_frame>
    <description>Visual Analogue Scale: scores on fatigue, dyspnea, cough and general wellbeing on a scale ranging from 0-10. Higher score indicates more complaint.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>VAS</measure>
    <time_frame>6 months</time_frame>
    <description>Visual Analogue Scale: scores on fatigue, dyspnea, cough and general wellbeing on a scale ranging from 0-10. Higher score indicates more complaint.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>VAS</measure>
    <time_frame>12 months</time_frame>
    <description>Visual Analogue Scale: scores on fatigue, dyspnea, cough and general wellbeing on a scale ranging from 0-10. Higher score indicates more complaint.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Temperature</measure>
    <time_frame>3 months</time_frame>
    <description>Body temperature measured with an thermometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oxygen measurements</measure>
    <time_frame>3 months</time_frame>
    <description>Oxygen saturation measured with an pulse oximeter</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oxygen measurements</measure>
    <time_frame>6 months</time_frame>
    <description>Oxygen saturation measured with an pulse oximeter</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oxygen measurements</measure>
    <time_frame>12 months</time_frame>
    <description>Oxygen saturation measured with an pulse oximeter</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Forced Vital Capacity (FVC) home spirometry in %</measure>
    <time_frame>3 months</time_frame>
    <description>FVC change measured with home spirometry at 3 months (in %)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Forced Vital Capacity (FVC) home spirometry in L</measure>
    <time_frame>3 months</time_frame>
    <description>FVC change measured with home spirometry at 3 months (in L)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Forced Vital Capacity (FVC) home spirometry in %</measure>
    <time_frame>6 months</time_frame>
    <description>FVC change measured with home spirometry at 6 months (in %)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Forced Vital Capacity (FVC) home spirometry in L</measure>
    <time_frame>6 months</time_frame>
    <description>FVC change measured with home spirometry at 6 months (in L)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Forced Vital Capacity (FVC) home spirometry in L</measure>
    <time_frame>12 months</time_frame>
    <description>FVC change measured with home spirometry at 12 months (in L)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Forced Vital Capacity (FVC) home spirometry in %</measure>
    <time_frame>12 months</time_frame>
    <description>FVC change measured with home spirometry at 12 months (in %)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Forced Vital Capacity (FVC) hospital spirometry in %</measure>
    <time_frame>3 months</time_frame>
    <description>FVC change measured with hospital spirometry and saturation at 3 months (in %)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Forced Vital Capacity (FVC) hospital spirometry in L</measure>
    <time_frame>3 months</time_frame>
    <description>FVC change measured with hospital spirometry and saturation at 3 months (in L)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Forced Vital Capacity (FVC) hospital spirometry in %</measure>
    <time_frame>6 months</time_frame>
    <description>FVC change measured with hospital spirometry and saturation at 6 months (in %)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Forced Vital Capacity (FVC) hospital spirometry in L</measure>
    <time_frame>6 months</time_frame>
    <description>FVC change measured with hospital spirometry and saturation at 6 months (in L)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Forced Vital Capacity (FVC) hospital spirometry in %</measure>
    <time_frame>12 months</time_frame>
    <description>FVC change measured with hospital spirometry and saturation at 12 months (in %)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Forced Vital Capacity (FVC) hospital spirometry in L</measure>
    <time_frame>12 months</time_frame>
    <description>FVC change measured with hospital spirometry and saturation at 12 months (in L)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence to weekly home spirometry</measure>
    <time_frame>1 year after inclusion</time_frame>
    <description>The percentage of patients completed weekly home spirometry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>EQ5D</measure>
    <time_frame>Baseline</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>EQ5D</measure>
    <time_frame>6 weeks</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>EQ5D</measure>
    <time_frame>3 months</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>EQ5D</measure>
    <time_frame>6 months</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>EQ5D</measure>
    <time_frame>9 months</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>EQ5D</measure>
    <time_frame>12 months</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FAS</measure>
    <time_frame>Baseline</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FAS</measure>
    <time_frame>6 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FAS</measure>
    <time_frame>3 months weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FAS</measure>
    <time_frame>6 months weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FAS</measure>
    <time_frame>9 months weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FAS</measure>
    <time_frame>12 months weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>GRoC</measure>
    <time_frame>Baseline</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>GRoC</measure>
    <time_frame>6 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>GRoC</measure>
    <time_frame>3 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>GRoC</measure>
    <time_frame>6 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>GRoC</measure>
    <time_frame>9 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>GRoC</measure>
    <time_frame>12 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ABC tool</measure>
    <time_frame>Baseline</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ABC tool</measure>
    <time_frame>6 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ABC tool</measure>
    <time_frame>3 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ABC tool</measure>
    <time_frame>6 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ABC tool</measure>
    <time_frame>9 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ABC tool</measure>
    <time_frame>12 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between FVC, HRCT patterns, symptoms and quality of life</measure>
    <time_frame>3 months</time_frame>
    <description>Correlation between FVC, HRCT patterns, symptoms and quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between FVC, HRCT patterns, symptoms and quality of life</measure>
    <time_frame>6 months</time_frame>
    <description>Correlation between FVC, HRCT patterns, symptoms and quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between FVC, HRCT patterns, symptoms and quality of life</measure>
    <time_frame>12 months</time_frame>
    <description>Correlation between FVC, HRCT patterns, symptoms and quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Predictors for the course of recovery of COVID-19 infection after hospital admission</measure>
    <time_frame>12 months</time_frame>
    <description>Predictors for the course of recovery of COVID-19 infection after hospital admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction of patients and caregivers with the use of a home monitoring system</measure>
    <time_frame>12 months</time_frame>
    <description>Healthcare provider and patient satisfaction and experience with the online application. Patients and healthcare providers are asked about their experiences and opinions on homemonitoring.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">133</enrollment>
  <condition>COVID-19</condition>
  <condition>Pulmonary Fibrosis</condition>
  <arm_group>
    <arm_group_label>Patients with COVID-19</arm_group_label>
    <description>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.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        150 patients admitted at the Erasmus Medical Center, Leiden University Medical Center and&#xD;
        the Amsterdam University Medical Center, location VUMC, with proven COVID-19 infection and&#xD;
        abnormalities on Chest X-ray/HRCT due to COVID-19 infection.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients admitted to the hospital with proven COVID-19 infection&#xD;
&#xD;
          -  Abnormalities on Chest X-ray/HRCT due to COVID-19 infection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not able to speak, read or write in the native language of the country where the&#xD;
             patient is included&#xD;
&#xD;
          -  Not able to comply to the study protocol, according to the judgement of the&#xD;
             investigator and/or patient&#xD;
&#xD;
          -  No access to internet&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>M.S. Wijsenbeek, dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Erasmus Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Amsterdam University Center - location VUmc</name>
      <address>
        <city>Amsterdam</city>
        <zip>1081 HV</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leiden University Medical Center</name>
      <address>
        <city>Leiden</city>
        <zip>2333 ZA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus MC</name>
      <address>
        <city>Rotterdam</city>
        <zip>3015 CD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>February 14, 2023</last_update_submitted>
  <last_update_submitted_qc>February 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Erasmus Medical Center</investigator_affiliation>
    <investigator_full_name>Marlies Wijsenbeek</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Home monitoring</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Pulmonary Fibrosis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04488562
org study id: MEC-2020-0318
nct id: NCT04488562
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: VAS
time frame: 3 months
description: Visual Analogue Scale: scores on fatigue, dyspnea, cough and general wellbeing on a scale ranging from 0-10. Higher score indicates more complaint.
measure: VAS
time frame: 6 months
description: Visual Analogue Scale: scores on fatigue, dyspnea, cough and general wellbeing on a scale ranging from 0-10. Higher score indicates more complaint.
measure: VAS
time frame: 12 months
description: Visual Analogue Scale: scores on fatigue, dyspnea, cough and general wellbeing on a scale ranging from 0-10. Higher score indicates more complaint.
measure: Temperature
time frame: 3 months
description: Body temperature measured with an thermometer
measure: Oxygen measurements
time frame: 3 months
description: Oxygen saturation measured with an pulse oximeter
measure: Oxygen measurements
time frame: 6 months
description: Oxygen saturation measured with an pulse oximeter
measure: Oxygen measurements
time frame: 12 months
description: Oxygen saturation measured with an pulse oximeter
measure: Forced Vital Capacity (FVC) home spirometry in %
time frame: 3 months
description: FVC change measured with home spirometry at 3 months (in %)
measure: Forced Vital Capacity (FVC) home spirometry in L
time frame: 3 months
description: FVC change measured with home spirometry at 3 months (in L)
measure: Forced Vital Capacity (FVC) home spirometry in %
time frame: 6 months
description: FVC change measured with home spirometry at 6 months (in %)
measure: Forced Vital Capacity (FVC) home spirometry in L
time frame: 6 months
description: FVC change measured with home spirometry at 6 months (in L)
measure: Forced Vital Capacity (FVC) home spirometry in L
time frame: 12 months
description: FVC change measured with home spirometry at 12 months (in L)
measure: Forced Vital Capacity (FVC) home spirometry in %
time frame: 12 months
description: FVC change measured with home spirometry at 12 months (in %)
measure: Forced Vital Capacity (FVC) hospital spirometry in %
time frame: 3 months
description: FVC change measured with hospital spirometry and saturation at 3 months (in %)
measure: Forced Vital Capacity (FVC) hospital spirometry in L
time frame: 3 months
description: FVC change measured with hospital spirometry and saturation at 3 months (in L)
measure: Forced Vital Capacity (FVC) hospital spirometry in %
time frame: 6 months
description: FVC change measured with hospital spirometry and saturation at 6 months (in %)
measure: Forced Vital Capacity (FVC) hospital spirometry in L
time frame: 6 months
description: FVC change measured with hospital spirometry and saturation at 6 months (in L)
measure: Forced Vital Capacity (FVC) hospital spirometry in %
time frame: 12 months
description: FVC change measured with hospital spirometry and saturation at 12 months (in %)
measure: Forced Vital Capacity (FVC) hospital spirometry in L
time frame: 12 months
description: FVC change measured with hospital spirometry and saturation at 12 months (in L)
measure: Adherence to weekly home spirometry
time frame: 1 year after inclusion
description: The percentage of patients completed weekly home spirometry
measure: EQ5D
time frame: Baseline
description: 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
measure: EQ5D
time frame: 6 weeks
description: 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
measure: EQ5D
time frame: 3 months
description: 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
measure: EQ5D
time frame: 6 months
description: 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
measure: EQ5D
time frame: 9 months
description: 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
measure: EQ5D
time frame: 12 months
description: 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
measure: FAS
time frame: Baseline
description: 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.
measure: FAS
time frame: 6 weeks
description: 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.
measure: FAS
time frame: 3 months weeks
description: 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.
measure: FAS
time frame: 6 months weeks
description: 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.
measure: FAS
time frame: 9 months weeks
description: 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.
measure: FAS
time frame: 12 months weeks
description: 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.
measure: GRoC
time frame: Baseline
description: 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.
measure: GRoC
time frame: 6 weeks
description: 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.
measure: GRoC
time frame: 3 months
description: 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.
measure: GRoC
time frame: 6 months
description: 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.
measure: GRoC
time frame: 9 months
description: 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.
measure: GRoC
time frame: 12 months
description: 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.
measure: ABC tool
time frame: Baseline
description: 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.
measure: ABC tool
time frame: 6 weeks
description: 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.
measure: ABC tool
time frame: 3 months
description: 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.
measure: ABC tool
time frame: 6 months
description: 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.
measure: ABC tool
time frame: 9 months
description: 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.
measure: ABC tool
time frame: 12 months
description: 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.
measure: Correlation between FVC, HRCT patterns, symptoms and quality of life
time frame: 3 months
description: Correlation between FVC, HRCT patterns, symptoms and quality of life
measure: Correlation between FVC, HRCT patterns, symptoms and quality of life
time frame: 6 months
description: Correlation between FVC, HRCT patterns, symptoms and quality of life
measure: Correlation between FVC, HRCT patterns, symptoms and quality of life
time frame: 12 months
description: Correlation between FVC, HRCT patterns, symptoms and quality of life
measure: Predictors for the course of recovery of COVID-19 infection after hospital admission
time frame: 12 months
description: Predictors for the course of recovery of COVID-19 infection after hospital admission
measure: Satisfaction of patients and caregivers with the use of a home monitoring system
time frame: 12 months
description: Healthcare provider and patient satisfaction and experience with the online application. Patients and healthcare providers are asked about their experiences and opinions on homemonitoring.
arm group label: Patients with COVID-19
description: 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.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: M.S. Wijsenbeek, dr
role: Principal Investigator
affiliation: Erasmus Medical Center
facility: 
facility: 
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Erasmus Medical Center
investigator full name: Marlies Wijsenbeek
investigator title: Principal Investigator
mesh term: COVID-19
mesh term: Pulmonary Fibrosis