<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/NCT04430049</url>
  </required_header>
  <id_info>
    <org_study_id>2020 HAD-Covid</org_study_id>
    <nct_id>NCT04430049</nct_id>
  </id_info>
  <brief_title>Impact of Covid-19 Restrictive Measure on Anxiety, Depression and PTSD for Relatives of ICU Patients</brief_title>
  <acronym>HAD-Covid</acronym>
  <official_title>Impact of the Restrictive Visiting Policy During the Covid-19 Pandemic on Anxiety, Depression and Post-traumatic Stress Disorder for Relatives of ICU Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</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 limit the pandemic Covid-19 infection, the French government imposed a closure of all&#xD;
      Intensive Care Unit (ICU). The family's visitations are prohibited during active Covid -19&#xD;
      pandemic in 2020 and in 2021. This restrictive visit policy could result in an increase in&#xD;
      symptoms of anxiety, depression or post-traumatic stress disorder for relatives of ICU&#xD;
      patients. The aim of this study is to compare symptoms of anxiety, depression or&#xD;
      post-traumatic stress for relatives of ICU patients during Covid period with those during no&#xD;
      Covid period (2020 and 2021) with those no Covid period (2022)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Observational multicenter study&#xD;
&#xD;
      Three groups are compared:&#xD;
&#xD;
        -  no visitation group. Enrollment during the application of national containment measures&#xD;
           to limit Covid pandemic in France: March to June 2020&#xD;
&#xD;
        -  restrictive visitation group. Enrollment during the application of national containment&#xD;
           measures to limit Covid pandemic in France: March to June 2021&#xD;
&#xD;
        -  open visit group. Enrollment during a no Covid period without restrictive visitation:&#xD;
           March to June 2022 The primary objective is to compare the Hospital Anxiety and&#xD;
           Depression Scale (HADS) for relative at 3-6 months after the ICU patient discharge&#xD;
           between the three groups The secondary objectives are&#xD;
&#xD;
        -  to compare the Post-Traumatic Stress Disorder (PTSD) for relative at 3-6 months after&#xD;
           the ICU patient discharge between the three groups&#xD;
&#xD;
        -  to compare the prevalence of significant symptoms of both anxiety and depression for&#xD;
           relative at 3-6 months after the ICU patient discharge between the three groups&#xD;
&#xD;
        -  to compare the prevalence of significant PTSD-related symptoms for relative at 3-6&#xD;
           months after the ICU patient discharge between the three groups&#xD;
&#xD;
        -  to identify the factor associated with significant symptoms of both anxiety and&#xD;
           depression&#xD;
&#xD;
        -  to identify the factor associated with significant PTSD-related symptoms&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 22, 2020</start_date>
  <completion_date type="Actual">November 9, 2022</completion_date>
  <primary_completion_date type="Actual">November 9, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Anxiety</measure>
    <time_frame>Between 3 and 6 months</time_frame>
    <description>Anxiety for relative of ICU patient will be measured by the Hospital Anxiety and depression scale (HADS) assessed between 3 and 6 months after the ICU discharge of patient.&#xD;
HADS ranges from 0 to 42; higher scores indicate worse symptoms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Depression</measure>
    <time_frame>Between 3 and 6 months</time_frame>
    <description>Anxiety for relative of ICU patient will be measured by the Hospital Anxiety and depression scale (HADS) assessed between 3 and 6 months after the ICU discharge of patient.&#xD;
HADS ranges from 0 to 42; higher scores indicate worse symptoms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>post-traumatic stress disorder</measure>
    <time_frame>between 3 and 6 months</time_frame>
    <description>Impact of post traumatic stress disorder for relative of ICU patient will be measured with the Event scale revised (IES-R) assessed between 3 and 6 months after the ICU discharge of patient.&#xD;
IES-R ranges from 0 to 88; higher scores indicate worse symptoms</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">811</enrollment>
  <condition>Covid-19</condition>
  <condition>Family Members</condition>
  <condition>Critical Illness</condition>
  <arm_group>
    <arm_group_label>no visitation group</arm_group_label>
    <description>relatives cannot visit ICU patient during Covid pandemic period in France</description>
  </arm_group>
  <arm_group>
    <arm_group_label>restrictive visitation group</arm_group_label>
    <description>relatives have restriction to visit ICU patient during Covid pandemic period in France</description>
  </arm_group>
  <arm_group>
    <arm_group_label>open visitation group</arm_group_label>
    <description>relatives can visit ICU patient during no Covid period in France</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Covid ICU containment measures</intervention_name>
    <description>The french containment measures during Covid-19 pandemic result in a restrictive visitation for relatives in ICU</description>
    <arm_group_label>no visitation group</arm_group_label>
    <arm_group_label>open visitation group</arm_group_label>
    <arm_group_label>restrictive visitation group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Relative of patient who was admitted in ICU and treated with mechanical ventilation or&#xD;
        non-invasive ventilation or high flow oxygen or amine administration during 24hours at&#xD;
        least.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Relative of patient who was admitted in ICU and treated with invasive mechanical&#xD;
             ventilation administration during 24hours at least.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Relative who declines the enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University hospital, Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <state>Auvergne</state>
        <zip>63000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Aurillac</name>
      <address>
        <city>Aurillac</city>
        <zip>15000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Cannes</name>
      <address>
        <city>Cannes</city>
        <zip>06150</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Jean Perrin</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Grenoble</name>
      <address>
        <city>Grenoble</city>
        <zip>38000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Le Puy-en-Velay</name>
      <address>
        <city>Le Puy-en-Velay</city>
        <zip>43000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University hopistal, Lyon</name>
      <address>
        <city>Lyon</city>
        <zip>69000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Moulins</name>
      <address>
        <city>Moulins</city>
        <zip>03000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Périgueux</name>
      <address>
        <city>Périgueux</city>
        <zip>24000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Rodez</name>
      <address>
        <city>Rodez</city>
        <zip>12000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Vichy</name>
      <address>
        <city>Vichy</city>
        <zip>03200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>February 6, 2023</last_update_submitted>
  <last_update_submitted_qc>February 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Covid-19</keyword>
  <keyword>Family</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Depression</keyword>
  <keyword>Post-traumatic stress disorder</keyword>
  <keyword>Intensive Care Unit</keyword>
  <keyword>Visitation</keyword>
  <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>Depression</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/NCT04430049
org study id: 2020 HAD-Covid
nct id: NCT04430049
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To limit the pandemic Covid-19 infection, the French government imposed a closure of all
      Intensive Care Unit (ICU). The family's visitations are prohibited during active Covid -19
      pandemic in 2020 and in 2021. This restrictive visit policy could result in an increase in
      symptoms of anxiety, depression or post-traumatic stress disorder for relatives of ICU
      patients. The aim of this study is to compare symptoms of anxiety, depression or
      post-traumatic stress for relatives of ICU patients during Covid period with those during no
      Covid period (2020 and 2021) with those no Covid period (2022)
Observational multicenter study

      Three groups are compared:

        -  no visitation group. Enrollment during the application of national containment measures
           to limit Covid pandemic in France: March to June 2020

        -  restrictive visitation group. Enrollment during the application of national containment
           measures to limit Covid pandemic in France: March to June 2021

        -  open visit group. Enrollment during a no Covid period without restrictive visitation:
           March to June 2022 The primary objective is to compare the Hospital Anxiety and
           Depression Scale (HADS) for relative at 3-6 months after the ICU patient discharge
           between the three groups The secondary objectives are

        -  to compare the Post-Traumatic Stress Disorder (PTSD) for relative at 3-6 months after
           the ICU patient discharge between the three groups

        -  to compare the prevalence of significant symptoms of both anxiety and depression for
           relative at 3-6 months after the ICU patient discharge between the three groups

        -  to compare the prevalence of significant PTSD-related symptoms for relative at 3-6
           months after the ICU patient discharge between the three groups

        -  to identify the factor associated with significant symptoms of both anxiety and
           depression

        -  to identify the factor associated with significant PTSD-related symptoms
observational model: Case-Control
time perspective: Prospective
measure: Anxiety
time frame: Between 3 and 6 months
description: Anxiety for relative of ICU patient will be measured by the Hospital Anxiety and depression scale (HADS) assessed between 3 and 6 months after the ICU discharge of patient.
HADS ranges from 0 to 42; higher scores indicate worse symptoms.
measure: Depression
time frame: Between 3 and 6 months
description: Anxiety for relative of ICU patient will be measured by the Hospital Anxiety and depression scale (HADS) assessed between 3 and 6 months after the ICU discharge of patient.
HADS ranges from 0 to 42; higher scores indicate worse symptoms.
measure: post-traumatic stress disorder
time frame: between 3 and 6 months
description: Impact of post traumatic stress disorder for relative of ICU patient will be measured with the Event scale revised (IES-R) assessed between 3 and 6 months after the ICU discharge of patient.
IES-R ranges from 0 to 88; higher scores indicate worse symptoms
arm group label: no visitation group
description: relatives cannot visit ICU patient during Covid pandemic period in France
arm group label: restrictive visitation group
description: relatives have restriction to visit ICU patient during Covid pandemic period in France
arm group label: open visitation group
description: relatives can visit ICU patient during no Covid period in France
intervention type: Procedure
intervention name: Covid ICU containment measures
description: The french containment measures during Covid-19 pandemic result in a restrictive visitation for relatives in ICU
arm group label: no visitation group
arm group label: open visitation group
arm group label: restrictive visitation group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Critical Illness
mesh term: Depression