<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/NCT04411238</url>
  </required_header>
  <id_info>
    <org_study_id>2020/28</org_study_id>
    <nct_id>NCT04411238</nct_id>
  </id_info>
  <brief_title>Skills of Home Helpers for a Better Quality of Life for Adults With Huntington's Disease Living at Home</brief_title>
  <acronym>COMPQUAHD</acronym>
  <official_title>Skills of Home Helpers for a Better Quality of Life for Adults With Huntington's Disease Living at Home</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Angers</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Angers</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>
      Huntington's disease often brings together 3 types of symptoms at one time or another of the&#xD;
      disease during its evolution: motor, cognitive and psychiatric. Management requires&#xD;
      comprehensive and multidisciplinary health, social or medico-social support. Its development&#xD;
      generates additional difficulties for professionals who very often qualify this disease as&#xD;
      &quot;very complex&quot; because it leads to a deep and severe impairment of physical and intellectual&#xD;
      capacities. The sick person gradually loses their autonomy and becomes dependent for the acts&#xD;
      of daily life, hence the choice of this disease for our study. Our study is focused on the&#xD;
      quality of life at home of patients followed by the Angers Reference Center, &quot;expert&quot; on&#xD;
      neurogenetic pathologies.&#xD;
&#xD;
      Studies focusing on patients' quality of life at home have so far never been undertaken for a&#xD;
      rare neurodegenerative disease like Huntington's disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 2020</start_date>
  <completion_date type="Anticipated">June 2022</completion_date>
  <primary_completion_date type="Anticipated">June 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Identify and compare the expectations and needs of patients with Huntington's disease, their caregivers, and home helpers, in terms of home support, based on interviews</measure>
    <time_frame>One day</time_frame>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Caregivers</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Home help</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>interview</intervention_name>
    <description>interview</description>
    <arm_group_label>Caregivers</arm_group_label>
    <arm_group_label>Home help</arm_group_label>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        90 participants, including 30 cases with Huntington's disease, 30 caregivers not concerned&#xD;
        himself with the risk of developing the disease and 30 home helper worker for Huntington's&#xD;
        disease patients.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Selection Criteria:&#xD;
&#xD;
        Patient group :&#xD;
&#xD;
          -  Genetic diagnosis of Huntington's disease&#xD;
&#xD;
          -  Symptomatic patient&#xD;
&#xD;
          -  Patient living at home&#xD;
&#xD;
          -  Person able to carry out the interviews provided for in the study&#xD;
&#xD;
        Caregiver group :&#xD;
&#xD;
          -  Person, defined within the meaning of the CNSA (National Solidarity Fund for Autonomy)&#xD;
             as a natural caregiver, not concerned himself by the risk of developing the disease&#xD;
&#xD;
          -  person able to carry out the interviews provided for in the study&#xD;
&#xD;
        Home Helper group :&#xD;
&#xD;
        - Professionals working at home with Huntington's disease patients employed by home help&#xD;
        service providers.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>May 27, 2020</last_update_submitted>
  <last_update_submitted_qc>May 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 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/NCT04411238
org study id: 2020/28
nct id: NCT04411238
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Huntington's disease often brings together 3 types of symptoms at one time or another of the
      disease during its evolution: motor, cognitive and psychiatric. Management requires
      comprehensive and multidisciplinary health, social or medico-social support. Its development
      generates additional difficulties for professionals who very often qualify this disease as
      "very complex" because it leads to a deep and severe impairment of physical and intellectual
      capacities. The sick person gradually loses their autonomy and becomes dependent for the acts
      of daily life, hence the choice of this disease for our study. Our study is focused on the
      quality of life at home of patients followed by the Angers Reference Center, "expert" on
      neurogenetic pathologies.

      Studies focusing on patients' quality of life at home have so far never been undertaken for a
      rare neurodegenerative disease like Huntington's disease.
observational model: Other
time perspective: Prospective
measure: Identify and compare the expectations and needs of patients with Huntington's disease, their caregivers, and home helpers, in terms of home support, based on interviews
time frame: One day
arm group label: Patients
arm group label: Caregivers
arm group label: Home help
intervention type: Other
intervention name: interview
description: interview
arm group label: Caregivers
arm group label: Home help
arm group label: Patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Huntington Disease