<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/NCT02218567</url>
  </required_header>
  <id_info>
    <org_study_id>2014-A00327-40</org_study_id>
    <nct_id>NCT02218567</nct_id>
  </id_info>
  <brief_title>Behavioural Problems in Huntington Disease : Analysis and Enhancement of Caregiver and Patient Experience</brief_title>
  <acronym>HUNTEXPERT</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Angers</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Angers</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study hypothesis is that caregivers experience allows them to develop a lot of knowledge&#xD;
      and know-how about behavioural problems in Huntington Disease and its consequences. The&#xD;
      purpose of this study is to collect, describe and analyse caregivers experience in order to&#xD;
      find and enhance their knowledge related to the adaptation to behavioural problems of&#xD;
      Huntington Disease patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    inclusion difficult&#xD;
  </why_stopped>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Huntington's Disease health-related Quality of Life questionnaire</measure>
    <time_frame>Baseline</time_frame>
    <description>The primary outcome is to find a list of caregiver competences necessary to prevent and adapt to behavioural problems of Huntington Disease patients.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Huntington Disease</condition>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Caregivers</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>questionnaire qualilty of life</intervention_name>
    <arm_group_label>Caregivers</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>psychological interview</intervention_name>
    <arm_group_label>Caregivers</arm_group_label>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>psychological tests</intervention_name>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Motor evaluation</intervention_name>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Behavioral evaluation</intervention_name>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>cognitive tests</intervention_name>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  For patients:&#xD;
&#xD;
               -  Patients with Huntington Disease declared&#xD;
&#xD;
               -  Huntington Disease diagnosed with abnormal number of CAG repeats: 38 &lt; nucleotide&#xD;
                  expansion (CAG)&#xD;
&#xD;
               -  Total Functional Capacity ≥ 7&#xD;
&#xD;
               -  Patients living with a caregiver&#xD;
&#xD;
               -  Aged 18 years and above&#xD;
&#xD;
               -  Subject gave its written consent&#xD;
&#xD;
          -  For caregivers :&#xD;
&#xD;
               -  No risk of caregiver having Huntington disease&#xD;
&#xD;
               -  Aged 18 years and above&#xD;
&#xD;
               -  Subject gave its written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  For patients:&#xD;
&#xD;
               -  Patient who do not live with a caregiver&#xD;
&#xD;
               -  No national health insurance affiliation&#xD;
&#xD;
               -  Being under guardianship&#xD;
&#xD;
          -  For caregivers :&#xD;
&#xD;
               -  Caregiver at risk for Huntington Disease&#xD;
&#xD;
               -  No national health insurance affiliation&#xD;
&#xD;
               -  Being under guardianship&#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 Angers</name>
      <address>
        <city>Angers</city>
        <state>Maine Et Loire</state>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2014</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>October 20, 2020</last_update_submitted>
  <last_update_submitted_qc>October 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Huntington Disease</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/NCT02218567
org study id: 2014-A00327-40
nct id: NCT02218567
lead sponsor: 
has dmc: No
The study hypothesis is that caregivers experience allows them to develop a lot of knowledge
      and know-how about behavioural problems in Huntington Disease and its consequences. The
      purpose of this study is to collect, describe and analyse caregivers experience in order to
      find and enhance their knowledge related to the adaptation to behavioural problems of
      Huntington Disease patients.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: The Huntington's Disease health-related Quality of Life questionnaire
time frame: Baseline
description: The primary outcome is to find a list of caregiver competences necessary to prevent and adapt to behavioural problems of Huntington Disease patients.
arm group label: Patients
arm group type: Other
arm group label: Caregivers
arm group type: Other
intervention type: Behavioral
intervention name: questionnaire qualilty of life
arm group label: Caregivers
intervention type: Behavioral
intervention name: psychological interview
arm group label: Caregivers
arm group label: Patients
intervention type: Behavioral
intervention name: psychological tests
arm group label: Patients
intervention type: Other
intervention name: Motor evaluation
arm group label: Patients
intervention type: Behavioral
intervention name: Behavioral evaluation
arm group label: Patients
intervention type: Behavioral
intervention name: cognitive tests
arm group label: Patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor
mesh term: Huntington Disease