<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/NCT04470869</url>
  </required_header>
  <id_info>
    <org_study_id>RC31/20/0190</org_study_id>
    <nct_id>NCT04470869</nct_id>
  </id_info>
  <brief_title>Impact on the OLAF Intervention to Prevent Post Traumatic Disorders During the Confinement.</brief_title>
  <acronym>OLAF</acronym>
  <official_title>Impact of the Psychiatric Intervention OLAF on the Post Traumatic Disorder in the Relatives of Patients Hospitalized in Intensive Care Unit During the SARS-Cov-2 Pandemic Confinement in France.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Toulouse</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 investigators thought that the confinement measure took in France could induce an&#xD;
      increase in the post traumatic syndrome in the relative of patient hospitalized in ICU during&#xD;
      this period indeed the restricted visit and the limited interaction with ICU team are&#xD;
      documented risk factors for PTSD in this population. The investigators designed an&#xD;
      intervention in order to prevent the effect of the confinement measures on PTSD in relatives&#xD;
      named OLAF. In this research the investigators aimed to study the impact on this intervention&#xD;
      on PTSD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The hospitalization of a relative in an intensive care unit is an important stress factor for&#xD;
      his/ her relatives and previous studies demonstrated that 33% post traumatic disorder (PTSD)&#xD;
      following the ICU stay of their loved ones. To response to this issue specific approach have&#xD;
      been designed to decrease the stress of the relatives named family centered care. Those&#xD;
      approaches are based on the interaction between the ICU team and the relatives and included&#xD;
      large time for visiting the patient in the ward. In France the restrictive measures&#xD;
      (confinement) took to combat the SARS-CoV-2 pandemic from the 17 march 2020 impacted&#xD;
      negatively those family centered care approach by prohibiting the visit in ICU and limiting&#xD;
      to interaction between ICU team and relatives to phone calls. The investigators thought that&#xD;
      this context could have for consequence an increase in relative anxiety and PTSD. The&#xD;
      investigators designed a care intervention named OLAF in order to limit the impact of the&#xD;
      confinement on relative psychological state. OLAF intervention permits to the two closest&#xD;
      relatives of the patient to be contacted by a psychiatrist and could benefit from a&#xD;
      specialized follow up. This intervention is completed by the implementation of virtual visits&#xD;
      by video conference that were proposed to the relatives as well as video interview with the&#xD;
      ICU team. In this study the investigators aimed to investigated the impact of this&#xD;
      intervention to prevent the PTSD in the relatives by comparing the PTSD prevalence in a group&#xD;
      of relatives that loved ones were hospitalized after the confinement measure but before the&#xD;
      OLAF intervention and a group of relatives that loved ones were hospitalized during the OLAF&#xD;
      intervention.&#xD;
&#xD;
      The relative will benefit from psychiatric interview 3 months after their loved ones leave&#xD;
      the ICU or died to collect information by phone about the confinement situation they&#xD;
      experiment, the satisfaction they had about the patient stay in ICU and their anxiety and&#xD;
      depression state. Three-month, six month and twelve months after the discharge of the dead&#xD;
      the relative information will be collected by phone about PTSD symptoms, anxiety and&#xD;
      depression and complicated grief in case of death of the patient.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 12, 2020</start_date>
  <completion_date type="Actual">October 12, 2021</completion_date>
  <primary_completion_date type="Actual">October 12, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>In this study we aimed to investigated the impact of this intervention to prevent the PTSD in the relatives by comparing the PTSD prevalence in a group of relatives that loved ones were hospitalized after the confinement measure but before the OLAF intervention and a group of relatives that loved ones were hospitalized during the OLAF intervention.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>incidence of PTSD observed 6 months after patient's discharge from the intensive care unit</measure>
    <time_frame>Month 6</time_frame>
    <description>To demonstrate the benefits of a comprehensive family approach (OLAF) on the incidence of PTSD observed in 2 close referents of a patient, 6 months after leaving the intensive care unit, in the context of confinement linked to the SARS pandemic- CoV2.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>incidence of PTSD observed 6 months after patient's death in the intensive care unit</measure>
    <time_frame>Month 6</time_frame>
    <description>The incidence of PTSD 6 months after patient's death in the intensive care unit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PTSD incidence at month 3</measure>
    <time_frame>Month 3</time_frame>
    <description>The incidence of PTSD 3 months after the death or discharge from the intensive care unit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PTSD incidence at month 12</measure>
    <time_frame>Month 12</time_frame>
    <description>The incidence of PTSD 12 months after the death or discharge from the intensive care unit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms incidence at month 3</measure>
    <time_frame>Month 3</time_frame>
    <description>The incidence of symptoms of anxiety and / or depression 3 months after death or discharge from the intensive care unit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms incidence at month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>The incidence of symptoms of anxiety and / or depression 6 months after death or discharge from the intensive care unit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms incidence at month 12</measure>
    <time_frame>Month 12</time_frame>
    <description>The incidence of symptoms of anxiety and / or depression 12 months after death or discharge from the intensive care unit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of persistent complicated grief at month 3</measure>
    <time_frame>Month 3</time_frame>
    <description>The incidence of persistent complicated grief 3 months after death in intensive care</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of persistent complicated grief at month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>The incidence of persistent complicated grief 6 months after death in intensive care</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of persistent complicated grief at month 12</measure>
    <time_frame>Month 12</time_frame>
    <description>The incidence of persistent complicated grief 12 months after death in intensive care</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">129</enrollment>
  <condition>Post Traumatic Stress Disorder</condition>
  <arm_group>
    <arm_group_label>OLAF group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The interventional group (OLAF) benefit from a psychiatric follow up, from virtual visiting of the patient and video interview with ICU team.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The control group contains the relatives of patients hospitalized after the confinement measure but before the OLAF intervention. This group benefit from phone contact with the ICU team at the admission in ICU then two contact per week minimum to one contact per day maximum during the stay, excepting the specific phone calls associated with favorable or unfavorable evolution.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Phone call</intervention_name>
    <description>The relatives of both groups will be contacted by phone one month after the discharge of the ICU of the death, three month after, six month after and twelve month after. During these interviews the PTSD symptoms, the anxiety and depression symptoms, the complicated grief symptoms (in case of death) and the satisfaction about the ICU stay will be collected.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>OLAF group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Contact person (defined as the person that bring a support to the patient et with who&#xD;
             the patient had close relationship) aged from more than 18 years old of a patient&#xD;
             hospitalized during the confinement and the restricted visited during the SARS-CoV2&#xD;
             pandemic. Two contact persons maximum will be included by patient.&#xD;
&#xD;
          -  Affiliated to the social security&#xD;
&#xD;
          -  Agreed to participated by oral consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Physical visits permitted by the end of the confinement&#xD;
&#xD;
          -  Language barrier&#xD;
&#xD;
          -  Sensorial handicap (blindness or deafness) compromising the comprehension of the&#xD;
             information&#xD;
&#xD;
          -  Legal protection of adults&#xD;
&#xD;
          -  Refusal of participation&#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>Juliette SALLES, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Toulouse</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Toulouse</name>
      <address>
        <city>Toulouse</city>
        <state>Occitanie</state>
        <zip>31000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>July 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>May 30, 2022</last_update_submitted>
  <last_update_submitted_qc>May 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>intensive care unit</keyword>
  <keyword>confinement</keyword>
  <keyword>SARS-CoV-2</keyword>
  <keyword>post-traumatic stress disorder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</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/NCT04470869
org study id: RC31/20/0190
nct id: NCT04470869
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The investigators thought that the confinement measure took in France could induce an
      increase in the post traumatic syndrome in the relative of patient hospitalized in ICU during
      this period indeed the restricted visit and the limited interaction with ICU team are
      documented risk factors for PTSD in this population. The investigators designed an
      intervention in order to prevent the effect of the confinement measures on PTSD in relatives
      named OLAF. In this research the investigators aimed to study the impact on this intervention
      on PTSD.
The hospitalization of a relative in an intensive care unit is an important stress factor for
      his/ her relatives and previous studies demonstrated that 33% post traumatic disorder (PTSD)
      following the ICU stay of their loved ones. To response to this issue specific approach have
      been designed to decrease the stress of the relatives named family centered care. Those
      approaches are based on the interaction between the ICU team and the relatives and included
      large time for visiting the patient in the ward. In France the restrictive measures
      (confinement) took to combat the SARS-CoV-2 pandemic from the 17 march 2020 impacted
      negatively those family centered care approach by prohibiting the visit in ICU and limiting
      to interaction between ICU team and relatives to phone calls. The investigators thought that
      this context could have for consequence an increase in relative anxiety and PTSD. The
      investigators designed a care intervention named OLAF in order to limit the impact of the
      confinement on relative psychological state. OLAF intervention permits to the two closest
      relatives of the patient to be contacted by a psychiatrist and could benefit from a
      specialized follow up. This intervention is completed by the implementation of virtual visits
      by video conference that were proposed to the relatives as well as video interview with the
      ICU team. In this study the investigators aimed to investigated the impact of this
      intervention to prevent the PTSD in the relatives by comparing the PTSD prevalence in a group
      of relatives that loved ones were hospitalized after the confinement measure but before the
      OLAF intervention and a group of relatives that loved ones were hospitalized during the OLAF
      intervention.

      The relative will benefit from psychiatric interview 3 months after their loved ones leave
      the ICU or died to collect information by phone about the confinement situation they
      experiment, the satisfaction they had about the patient stay in ICU and their anxiety and
      depression state. Three-month, six month and twelve months after the discharge of the dead
      the relative information will be collected by phone about PTSD symptoms, anxiety and
      depression and complicated grief in case of death of the patient.
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: In this study we aimed to investigated the impact of this intervention to prevent the PTSD in the relatives by comparing the PTSD prevalence in a group of relatives that loved ones were hospitalized after the confinement measure but before the OLAF intervention and a group of relatives that loved ones were hospitalized during the OLAF intervention.
primary purpose: Prevention
masking: None (Open Label)
measure: incidence of PTSD observed 6 months after patient's discharge from the intensive care unit
time frame: Month 6
description: To demonstrate the benefits of a comprehensive family approach (OLAF) on the incidence of PTSD observed in 2 close referents of a patient, 6 months after leaving the intensive care unit, in the context of confinement linked to the SARS pandemic- CoV2.
measure: incidence of PTSD observed 6 months after patient's death in the intensive care unit
time frame: Month 6
description: The incidence of PTSD 6 months after patient's death in the intensive care unit
measure: PTSD incidence at month 3
time frame: Month 3
description: The incidence of PTSD 3 months after the death or discharge from the intensive care unit
measure: PTSD incidence at month 12
time frame: Month 12
description: The incidence of PTSD 12 months after the death or discharge from the intensive care unit
measure: Symptoms incidence at month 3
time frame: Month 3
description: The incidence of symptoms of anxiety and / or depression 3 months after death or discharge from the intensive care unit
measure: Symptoms incidence at month 6
time frame: Month 6
description: The incidence of symptoms of anxiety and / or depression 6 months after death or discharge from the intensive care unit
measure: Symptoms incidence at month 12
time frame: Month 12
description: The incidence of symptoms of anxiety and / or depression 12 months after death or discharge from the intensive care unit
measure: incidence of persistent complicated grief at month 3
time frame: Month 3
description: The incidence of persistent complicated grief 3 months after death in intensive care
measure: incidence of persistent complicated grief at month 6
time frame: Month 6
description: The incidence of persistent complicated grief 6 months after death in intensive care
measure: incidence of persistent complicated grief at month 12
time frame: Month 12
description: The incidence of persistent complicated grief 12 months after death in intensive care
arm group label: OLAF group
arm group type: Experimental
description: The interventional group (OLAF) benefit from a psychiatric follow up, from virtual visiting of the patient and video interview with ICU team.
arm group label: Control
arm group type: Placebo Comparator
description: The control group contains the relatives of patients hospitalized after the confinement measure but before the OLAF intervention. This group benefit from phone contact with the ICU team at the admission in ICU then two contact per week minimum to one contact per day maximum during the stay, excepting the specific phone calls associated with favorable or unfavorable evolution.
intervention type: Other
intervention name: Phone call
description: The relatives of both groups will be contacted by phone one month after the discharge of the ICU of the death, three month after, six month after and twelve month after. During these interviews the PTSD symptoms, the anxiety and depression symptoms, the complicated grief symptoms (in case of death) and the satisfaction about the ICU stay will be collected.
arm group label: Control
arm group label: OLAF group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Juliette SALLES, MD
role: Principal Investigator
affiliation: University Hospital, Toulouse
facility: 
country: France
responsible party type: Sponsor
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic