<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/NCT04492761</url>
  </required_header>
  <id_info>
    <org_study_id>2019-53</org_study_id>
    <nct_id>NCT04492761</nct_id>
  </id_info>
  <brief_title>Family Impact of Polyhandicap: a Mixed Methodological Approach</brief_title>
  <acronym>PolyMiMe</acronym>
  <official_title>Family Impact of Polyhandicap: Mixed Methodological Approach</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique Hopitaux De Marseille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique Hopitaux De Marseille</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>
      Polyhandicap (PLH) is a complex disability condition corresponding to a chronic affliction&#xD;
      occurring in an immature brain, leading to the combination of profound mental retardation and&#xD;
      serious motor deficit, resulting in an extreme restriction of autonomy and communication. In&#xD;
      a preliminary work, we demonstrated that French families reporteda deterioration of the&#xD;
      quality of life. This first study, based on a cross-sectional study and quantitative methods,&#xD;
      did not allow to explore: 1) the dynamic aspect and the evolution over time of this&#xD;
      experience, 2) the mechanisms underlying the difficulties encountered, the needs and&#xD;
      expectations of families&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2021</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Qualite of life</measure>
    <time_frame>5 years</time_frame>
    <description>WHOQOL-Bref</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>interview content</measure>
    <time_frame>2 hours</time_frame>
    <description>semi-structured interviews</description>
  </secondary_outcome>
  <enrollment type="Anticipated">260</enrollment>
  <condition>Polyhandicap</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>qualitative study</intervention_name>
    <description>The qualitative approach will be based on content analysis of - Isemi-structured nterviews of families</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        - family member (parent, siblings, uncle / aunt) of a person with a severe multiple&#xD;
        disability whose age is between 8 and 35 years old&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Familial caregivers: member of a family of a polyhandicapped person aged from 8 to 35&#xD;
             years old&#xD;
&#xD;
          -  Patients: with severe polyhandicap defined by the combination of motor deficiency and&#xD;
             intellectual impairment associated with everyday life dependence, restricted mobility&#xD;
             and age at onset of cerebral lesion below 3 years old&#xD;
&#xD;
          -  Written consent signed by caregivers for participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  caregivers refusing to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean Olivier ARNAUD</last_name>
    <role>Study Director</role>
    <affiliation>Assistance Publique Hôpitauix de Marseille</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Karine Baumstarck</last_name>
    <phone>04 91 32 44 59</phone>
    <email>karine.baumstarck@univ-amu.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Assistance Publique Hôpiatuix de Marseille</name>
      <address>
        <city>Marseille</city>
        <zip>13354</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Karine BAUMSTARCK</last_name>
      <phone>04 91 32 44 59</phone>
      <email>karine.baumstarck@univ-amu.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT04492761
org study id: 2019-53
nct id: NCT04492761
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Polyhandicap (PLH) is a complex disability condition corresponding to a chronic affliction
      occurring in an immature brain, leading to the combination of profound mental retardation and
      serious motor deficit, resulting in an extreme restriction of autonomy and communication. In
      a preliminary work, we demonstrated that French families reporteda deterioration of the
      quality of life. This first study, based on a cross-sectional study and quantitative methods,
      did not allow to explore: 1) the dynamic aspect and the evolution over time of this
      experience, 2) the mechanisms underlying the difficulties encountered, the needs and
      expectations of families
observational model: Cohort
time perspective: Prospective
measure: Qualite of life
time frame: 5 years
description: WHOQOL-Bref
measure: interview content
time frame: 2 hours
description: semi-structured interviews
intervention type: Behavioral
intervention name: qualitative study
description: The qualitative approach will be based on content analysis of - Isemi-structured nterviews of families
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 8 Years
maximum age: 35 Years
healthy volunteers: No
last name: Jean Olivier ARNAUD
role: Study Director
affiliation: Assistance Publique Hôpitauix de Marseille
last name: Karine Baumstarck
phone: 04 91 32 44 59
email: karine.baumstarck@univ-amu.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor