<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/NCT04477473</url>
  </required_header>
  <id_info>
    <org_study_id>2020-01509</org_study_id>
    <nct_id>NCT04477473</nct_id>
  </id_info>
  <brief_title>Perceived Impact of the COVID-19 Pandemic on Medical Management and Symptoms in a High Risk Group</brief_title>
  <official_title>Perceived Impact of the COVID-19 Pandemic on Medical Management and Symptoms in a High Risk Group: Patients Under Long Term Noninvasive Ventilation for Chronic Hypercapnic Respiratory Failure in Geneva. An Observational Monocentric Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Geneva</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Geneva</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Swiss population underwent a period of confinement related to the COVID-19 pandemic&#xD;
      (March 16 to May 11, 2020) decided by the Swiss Federal Government. Among the Swiss&#xD;
      population, certain groups were identified as vulnerable subjects by the Federal Office of&#xD;
      Public Health. This study focuses on the perceived impact of this period on health care and&#xD;
      health status in a specific vulnerable group: patients under long term noninvasive&#xD;
      ventilation (respiratory support) at home for chronic respiratory failure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Swiss population underwent a period of confinement related to the COVID-19 pandemic&#xD;
      (March 16 to May 11, 2020) decided by the Swiss Federal Government. Among the Swiss&#xD;
      population, certain groups were identified as vulnerable subjects by the Federal Office of&#xD;
      Public Health. This study focuses on the perceived impact of this period on health care and&#xD;
      health status in a specific vulnerable group: patients under long term noninvasive&#xD;
      ventilation (respiratory support) at home for chronic respiratory failure.&#xD;
&#xD;
      The objective is to determine, in a specific vulnerable group, how the confinement related to&#xD;
      the COVID-19 pandemic affected health care and health status, as perceived by the patients.&#xD;
&#xD;
      The primary outcome is a questionnaire focusing on practical health care issues regarding&#xD;
      respiratory support, health status and perception of the COVID-19 issue:&#xD;
&#xD;
        -  Symptom score (related to noninvasive ventilation: NIV)&#xD;
&#xD;
        -  Thymic disturbances (score of anxiety and depression)&#xD;
&#xD;
        -  Compliance to treatment (assessed via tele-monitoring: routine procedure)&#xD;
&#xD;
      It is a non-interventional questionnaire-based observational study of patients followed by&#xD;
      the Division of Pulmonology of Geneva University Hospitals with home NIV, aged above 18 years&#xD;
      of age and in a stable clinical condition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 30, 2020</start_date>
  <completion_date type="Actual">August 31, 2020</completion_date>
  <primary_completion_date type="Actual">August 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Questionnaire</measure>
    <time_frame>2 months</time_frame>
    <description>Questionnaire focusing on practical health care issues regarding respiratory support, health status and perception of the COVID-19 issue:&#xD;
Symptom score (related to noninvasive ventilation: NIV): S3-NIV (non-invasive ventilation), score ranging from 0 to 10, the lowest possible score (0) corresponds to the highest impact of disease and treatment, the highest possible score (10) corresponds to the lowest impact of disease and treatment.&#xD;
Thymic disturbances (score of anxiety and depression): HADS (Hospital Anxiety and Depression Scale), score ranging from 0 to 21, 0-7 = normal, 8-10 borderline abnormal, 11-21 =abnormal&#xD;
COVID confinement questionnaire: de novo questionnaire, Minimal Clinically Important Differences (MCID) unknown</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">66</enrollment>
  <condition>COVID-19 Pandemic</condition>
  <condition>Vulnerable Subjects</condition>
  <condition>Long-term Non-invasive Ventilation</condition>
  <arm_group>
    <arm_group_label>Vulnerable subjects</arm_group_label>
    <description>Patients under long-term non-invasive ventilation (respiratory support) at home for chronic respiratory failure</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire-based observational study</intervention_name>
    <description>Questionnaire focusing on practical health care issues regarding respiratory support, health status and perception of the COVID-19 issue:&#xD;
Symptom score (related to noninvasive ventilation: NIV)&#xD;
Thymic disturbances (score of anxiety and depression)&#xD;
Compliance to treatment (assessed via tele-monitoring: routine procedure)</description>
    <arm_group_label>Vulnerable subjects</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The population chosen (patients with chronic hypercapnic respiratory failure treated by&#xD;
        noninvasive ventilation) is:&#xD;
&#xD;
          -  One of the main focuses of interest of our research group, for close to 30 years&#xD;
&#xD;
          -  One of our main clinical activities in our outpatient pulmonary division&#xD;
&#xD;
          -  An interesting group because, although these subjects must be considered as vulnerable&#xD;
             in case of COVID-19, they have - albeit for COPD - a prognosis of several years of&#xD;
             survival&#xD;
&#xD;
          -  A group for which the findings of our study can be rapidly translated into adapting&#xD;
             clinical practice and management&#xD;
&#xD;
          -  An interesting group because although they are often very limited in their activities&#xD;
             of daily life (ADL), they are also very resilient, with remarkable coping strategies&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients followed by the Division of Pulmonology of Geneva University Hospitals with&#xD;
             home NIV&#xD;
&#xD;
          -  Aged above 18 years of age&#xD;
&#xD;
          -  Stable clinical condition&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age below 18 years of age&#xD;
&#xD;
          -  Unwillingness to participate&#xD;
&#xD;
          -  Unstable clinical condition&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Jean-Paul Janssens, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Geneva</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre antituberculeux; Geneva University Hospital</name>
      <address>
        <city>Geneva</city>
        <state>Geneva 14</state>
        <zip>1211</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>October 31, 2021</last_update_submitted>
  <last_update_submitted_qc>October 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Geneva</investigator_affiliation>
    <investigator_full_name>Jean-Paul Janssens</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</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/NCT04477473
org study id: 2020-01509
nct id: NCT04477473
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The Swiss population underwent a period of confinement related to the COVID-19 pandemic
      (March 16 to May 11, 2020) decided by the Swiss Federal Government. Among the Swiss
      population, certain groups were identified as vulnerable subjects by the Federal Office of
      Public Health. This study focuses on the perceived impact of this period on health care and
      health status in a specific vulnerable group: patients under long term noninvasive
      ventilation (respiratory support) at home for chronic respiratory failure.
The Swiss population underwent a period of confinement related to the COVID-19 pandemic
      (March 16 to May 11, 2020) decided by the Swiss Federal Government. Among the Swiss
      population, certain groups were identified as vulnerable subjects by the Federal Office of
      Public Health. This study focuses on the perceived impact of this period on health care and
      health status in a specific vulnerable group: patients under long term noninvasive
      ventilation (respiratory support) at home for chronic respiratory failure.

      The objective is to determine, in a specific vulnerable group, how the confinement related to
      the COVID-19 pandemic affected health care and health status, as perceived by the patients.

      The primary outcome is a questionnaire focusing on practical health care issues regarding
      respiratory support, health status and perception of the COVID-19 issue:

        -  Symptom score (related to noninvasive ventilation: NIV)

        -  Thymic disturbances (score of anxiety and depression)

        -  Compliance to treatment (assessed via tele-monitoring: routine procedure)

      It is a non-interventional questionnaire-based observational study of patients followed by
      the Division of Pulmonology of Geneva University Hospitals with home NIV, aged above 18 years
      of age and in a stable clinical condition.
observational model: Other
time perspective: Prospective
measure: Questionnaire
time frame: 2 months
description: Questionnaire focusing on practical health care issues regarding respiratory support, health status and perception of the COVID-19 issue:
Symptom score (related to noninvasive ventilation: NIV): S3-NIV (non-invasive ventilation), score ranging from 0 to 10, the lowest possible score (0) corresponds to the highest impact of disease and treatment, the highest possible score (10) corresponds to the lowest impact of disease and treatment.
Thymic disturbances (score of anxiety and depression): HADS (Hospital Anxiety and Depression Scale), score ranging from 0 to 21, 0-7 = normal, 8-10 borderline abnormal, 11-21 =abnormal
COVID confinement questionnaire: de novo questionnaire, Minimal Clinically Important Differences (MCID) unknown
arm group label: Vulnerable subjects
description: Patients under long-term non-invasive ventilation (respiratory support) at home for chronic respiratory failure
intervention type: Other
intervention name: Questionnaire-based observational study
description: Questionnaire focusing on practical health care issues regarding respiratory support, health status and perception of the COVID-19 issue:
Symptom score (related to noninvasive ventilation: NIV)
Thymic disturbances (score of anxiety and depression)
Compliance to treatment (assessed via tele-monitoring: routine procedure)
arm group label: Vulnerable subjects
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
last name: Jean-Paul Janssens, M.D
role: Principal Investigator
affiliation: University Hospital, Geneva
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Geneva
investigator full name: Jean-Paul Janssens
investigator title: Professor
mesh term: COVID-19