<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/NCT04498507</url>
  </required_header>
  <id_info>
    <org_study_id>Family COVID</org_study_id>
    <nct_id>NCT04498507</nct_id>
  </id_info>
  <brief_title>Psychosocial Outcomes in Families of COVID-19 ICU Patients</brief_title>
  <official_title>Psychosocial Outcomes in Families of Patients Admitted in ICU for COVID-19 During the Pandemic in Belgium</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Liege</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Liege</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>
      During the first part of the SRAS-COV2 pandemic, families were not allowed to visit the&#xD;
      patients in ICU. We know that families can develop &quot;Family-PICS&quot; after their relatives' ICU&#xD;
      stay. The aim of the study is to study the psychosocial outcomes of families of patients who&#xD;
      were admitted in ICU for COVID-19 during the pandemic. The second objective was to search for&#xD;
      any differences in outcomes whether families benefited from video-conferences with the&#xD;
      medical team and their relatives or not during the ICU stay.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 16, 2020</start_date>
  <completion_date type="Actual">October 30, 2020</completion_date>
  <primary_completion_date type="Actual">October 30, 2020</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>occurence of anxiety and depression</measure>
    <time_frame>one month after ICU discharge</time_frame>
    <description>sub scores of HADS questionnaire &gt;7</description>
  </primary_outcome>
  <primary_outcome>
    <measure>occurence of anxiety and depression</measure>
    <time_frame>three months after ICU discharge</time_frame>
    <description>sub scores of HADS questionnaire &gt;7</description>
  </primary_outcome>
  <primary_outcome>
    <measure>occurence of acute stress</measure>
    <time_frame>one month after ICU discharge</time_frame>
    <description>IES-R score &gt; 22</description>
  </primary_outcome>
  <primary_outcome>
    <measure>occurence of post-traumatic stress disorder</measure>
    <time_frame>three months after ICU discharge</time_frame>
    <description>IES-R score &gt; 36</description>
  </primary_outcome>
  <primary_outcome>
    <measure>quality of life</measure>
    <time_frame>one month after ICU discharge</time_frame>
    <description>assessed using the EQ-5D questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>quality of life</measure>
    <time_frame>three months after ICU discharge</time_frame>
    <description>assessed using the EQ-5D questionnaire</description>
  </primary_outcome>
  <enrollment type="Actual">39</enrollment>
  <condition>Critical Illness</condition>
  <condition>Family</condition>
  <condition>Psychological Stress</condition>
  <condition>Covid19</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>HADS questionnaire</intervention_name>
    <description>Patients will be asked to answer to 3 questionnaires about anxiety and depression, post-traumatic stress disorder and health-related quality of life</description>
    <other_name>IES-R questionnaire</other_name>
    <other_name>EQ-5D questionnaire</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        this study includes the family members of patients who were admitted in ICU for sever&#xD;
        COVID-19 during the first part of the pandemic when visits in ICU were not allowed&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  the referent family member of any patient admitted in ICU for COVID-19 during the&#xD;
             first part of the pandemic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cognitive disorders&#xD;
&#xD;
          -  not French-speaking&#xD;
&#xD;
          -  refusal to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Hospital of Liège</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>August 1, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>November 2, 2020</last_update_submitted>
  <last_update_submitted_qc>November 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Liege</investigator_affiliation>
    <investigator_full_name>Rousseau</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Critical Illness</mesh_term>
    <mesh_term>Stress, Psychological</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04498507
org study id: Family COVID
nct id: NCT04498507
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
During the first part of the SRAS-COV2 pandemic, families were not allowed to visit the
      patients in ICU. We know that families can develop "Family-PICS" after their relatives' ICU
      stay. The aim of the study is to study the psychosocial outcomes of families of patients who
      were admitted in ICU for COVID-19 during the pandemic. The second objective was to search for
      any differences in outcomes whether families benefited from video-conferences with the
      medical team and their relatives or not during the ICU stay.
observational model: Cohort
time perspective: Prospective
measure: occurence of anxiety and depression
time frame: one month after ICU discharge
description: sub scores of HADS questionnaire >7
measure: occurence of anxiety and depression
time frame: three months after ICU discharge
description: sub scores of HADS questionnaire >7
measure: occurence of acute stress
time frame: one month after ICU discharge
description: IES-R score > 22
measure: occurence of post-traumatic stress disorder
time frame: three months after ICU discharge
description: IES-R score > 36
measure: quality of life
time frame: one month after ICU discharge
description: assessed using the EQ-5D questionnaire
measure: quality of life
time frame: three months after ICU discharge
description: assessed using the EQ-5D questionnaire
intervention type: Diagnostic Test
intervention name: HADS questionnaire
description: Patients will be asked to answer to 3 questionnaires about anxiety and depression, post-traumatic stress disorder and health-related quality of life
other name: IES-R questionnaire
other name: EQ-5D questionnaire
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: University of Liege
investigator full name: Rousseau
investigator title: MD, PhD
mesh term: COVID-19
mesh term: Critical Illness
mesh term: Stress, Psychological
sharing ipd: No