<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/NCT04423809</url>
  </required_header>
  <id_info>
    <org_study_id>2014-A01499-38</org_study_id>
    <nct_id>NCT04423809</nct_id>
  </id_info>
  <brief_title>Impact of Burden in Caregivers of Patients Hospitalized for a Psychotic Episode: a Multicenter Study</brief_title>
  <acronym>AFP</acronym>
  <official_title>Impact of Burden in Caregivers of Patients Hospitalized for a Psychotic Episode: a Multicenter Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre hospitalier de Ville-Evrard, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre hospitalier de Ville-Evrard, France</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Family support is a positive predictor for psychiatric patients. For example, since the&#xD;
      1980s, it has been shown that family psychoeducation improves patient adherence to care and&#xD;
      statistically decreases patient relapse and hospitalization rates by half, resulting in lower&#xD;
      care costs. Yet, the stress of hospitalizing a patient, seeing the feelings of shame or guilt&#xD;
      of caregiver and the impact on their quality of life are rarely taken into account by&#xD;
      caregivers during the first weeks hospitalization in a patient's psychiatry.&#xD;
&#xD;
      Barrelet emphasizes the importance of organizing the meeting in the first hours of&#xD;
      hospitalization with the family in order to strengthen the alliance, to improve&#xD;
      communication.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 10, 2015</start_date>
  <completion_date type="Actual">March 27, 2020</completion_date>
  <primary_completion_date type="Actual">June 8, 2018</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Center for Epidemiologic Studies-Depression scale</measure>
    <time_frame>at patient admission</time_frame>
    <description>is a simple tool for assessing depressive symptomatology for the general population</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Zarit burden inventory</measure>
    <time_frame>at patient admission</time_frame>
    <description>to assess burden</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short form 36</measure>
    <time_frame>at patient admission</time_frame>
    <description>To assess quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Semi-directional interview</measure>
    <time_frame>At patient admission</time_frame>
    <description>It consists of five items: subjective feeling, quality of life, social life, mood of the caregiver.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">161</enrollment>
  <condition>The Objective of Our Study is to Assess and Take Into Account Early on the Suffering of Family Members</condition>
  <arm_group>
    <arm_group_label>caregivers of adult patients hospitalized in psychiatry</arm_group_label>
    <description>a face-to-face interview with a nurse and self-assessment scales.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>clinical assessment</intervention_name>
    <description>assessment of caregivers suffering when a family member is hospitalized</description>
    <arm_group_label>caregivers of adult patients hospitalized in psychiatry</arm_group_label>
    <other_name>Interview</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        caregiver of patient hospitalised in psychiatry&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Family members or relatives&#xD;
&#xD;
          -  Over 18 years&#xD;
&#xD;
          -  Having a relative&#xD;
&#xD;
               -  First hospitalized in psychiatry or hospitalized in psychiatry within 5 years&#xD;
&#xD;
               -  Over 18 years of age&#xD;
&#xD;
               -  Psychotic episode&#xD;
&#xD;
               -  Having been informed of their participation in this study&#xD;
&#xD;
          -  In regular contact with the patient prior to hospitalization, at least 4 hours per&#xD;
             week.&#xD;
&#xD;
          -  French language&#xD;
&#xD;
          -  Signed written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -Psychiatric pathology of another family member than the hospitalized.&#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>Unité de recherche clinique</name>
      <address>
        <city>Neuilly Sur Marne</city>
        <state>Île De France</state>
        <zip>93330</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 5, 2020</last_update_submitted>
  <last_update_submitted_qc>June 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre hospitalier de Ville-Evrard, France</investigator_affiliation>
    <investigator_full_name>Januel</investigator_full_name>
    <investigator_title>head of the clinical research unit</investigator_title>
  </responsible_party>
  <keyword>Psychiatry Nurse Burden Caregiver</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Psychotic Disorders</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/NCT04423809
org study id: 2014-A01499-38
nct id: NCT04423809
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Family support is a positive predictor for psychiatric patients. For example, since the
      1980s, it has been shown that family psychoeducation improves patient adherence to care and
      statistically decreases patient relapse and hospitalization rates by half, resulting in lower
      care costs. Yet, the stress of hospitalizing a patient, seeing the feelings of shame or guilt
      of caregiver and the impact on their quality of life are rarely taken into account by
      caregivers during the first weeks hospitalization in a patient's psychiatry.

      Barrelet emphasizes the importance of organizing the meeting in the first hours of
      hospitalization with the family in order to strengthen the alliance, to improve
      communication.
observational model: Cohort
time perspective: Retrospective
measure: Center for Epidemiologic Studies-Depression scale
time frame: at patient admission
description: is a simple tool for assessing depressive symptomatology for the general population
measure: Zarit burden inventory
time frame: at patient admission
description: to assess burden
measure: Short form 36
time frame: at patient admission
description: To assess quality of life
measure: Semi-directional interview
time frame: At patient admission
description: It consists of five items: subjective feeling, quality of life, social life, mood of the caregiver.
arm group label: caregivers of adult patients hospitalized in psychiatry
description: a face-to-face interview with a nurse and self-assessment scales.
intervention type: Other
intervention name: clinical assessment
description: assessment of caregivers suffering when a family member is hospitalized
arm group label: caregivers of adult patients hospitalized in psychiatry
other name: Interview
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: France
responsible party type: Principal Investigator
investigator affiliation: Centre hospitalier de Ville-Evrard, France
investigator full name: Januel
investigator title: head of the clinical research unit
mesh term: Mental Disorders
mesh term: Psychotic Disorders