xml: <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/NCT05978245</url>
    </required_header>
    <id_info>
      <org_study_id>CHSD_0027_MPR</org_study_id>
      <nct_id>NCT05978245</nct_id>
    </id_info>
    <brief_title>Obtaining Reliable Linguistic and Cultural Validation of the Questionnaires Cargier Bruden Inventony (CBI) and Zarit-12</brief_title>
    <acronym>VALI-CBIZ</acronym>
    <official_title>Obtaining Reliable Linguistic and Cultural Validation of the Questionnaires Cargier Bruden Inventony (CBI) and Zarit-12, Translate From English for Use in France</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Hospitalier de Saint-Denis</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centre Hospitalier de Saint-Denis</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>
        To validate the 2 questionnaires ZARIT-12 and CBI it is important to go through several&#xD;
        stages:&#xD;
  &#xD;
          1. translation stage : during this stage there will be a meeting of experts to Validate the&#xD;
             test version in French by 4 Bilingual translators of the French and English mother&#xD;
             tongue.&#xD;
  &#xD;
          2. pilot stage : recruit a number of 30 neurological patients' caregivers, in order to&#xD;
             validate the comprehension, thus obtaining the final version of the questionnaire.&#xD;
  &#xD;
          3. Validation stage : the two questionnaires have been validated, in this stage there&#xD;
             should be a recruitment of 264 participants for the CBI questionnaire and 120&#xD;
             participants for the ZARIT-12 questionnaire, and these 2 questionnaires will be deliver&#xD;
             to the participant on the same day.&#xD;
  &#xD;
               -  The first questionnary will have to be filled the day they get the questionnary&#xD;
                  (day 1).&#xD;
  &#xD;
               -  The second one must be completed and sent fourteen days later (day 14).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        To validate the 2 questionnaires ZARIT-12 and CBI it is important to go through several&#xD;
        stages:&#xD;
  &#xD;
          1. translation stage : during this stage there will be a meeting of experts to Validate the&#xD;
             test version in French by 4 Bilingual translators of the French and English mother&#xD;
             tongue.&#xD;
  &#xD;
          2. pilot stage : recruit a number of 30 neurological patients' caregivers, in order to&#xD;
             validate the comprehension, thus obtaining the final version of the questionnaire.&#xD;
  &#xD;
          3. Validation stage : the two questionnaires have been validated, in this stage there&#xD;
             should be a recruitment of 264 participants for the CBI questionnaire and 120&#xD;
             participants for the ZARIT-12 questionnaire, and these 2 questionnaires will be deliver&#xD;
             to the participant on day 1. The first questionnary will have to be filled on day 1 and&#xD;
             the second one must be completed and sent fourteen days later (so on day 14)&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 31, 2024</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>French-language linguistic and cultural validation of caregiver burden questionnaires (Zarit-12) in a population of neurological patients</measure>
      <time_frame>two days (day one and day fourteen)</time_frame>
      <description>ZARIT-12</description>
    </primary_outcome>
    <primary_outcome>
      <measure>French-language linguistic and cultural validation of caregiver burden questionnaires (CBI) in a population of neurological patients</measure>
      <time_frame>two days (day one and day fourteen)</time_frame>
      <description>CBI questionnaire</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Identifying populations at higher risk of burden</measure>
      <time_frame>two days (day one and day fourteen)</time_frame>
      <description>ZARTI-2</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Identifying populations at higher risk of burden</measure>
      <time_frame>two days (day one and day fourteen)</time_frame>
      <description>CBI questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Identification of risk factors for caregiver's burden</measure>
      <time_frame>two days (day one and day fourteen)</time_frame>
      <description>ZARIT-12</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Identification of risk factors for caregiver's burden</measure>
      <time_frame>two days (day one and day fourteen)</time_frame>
      <description>CBI questionnaire</description>
    </secondary_outcome>
    <enrollment type="Anticipated">264</enrollment>
    <condition>Physical Medicine and Rehabilitation</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients consulted in the hospital wards included in the research and suffering from&#xD;
          neurological pathology with the inclusion of caregivers of patients who have had a&#xD;
          consultation.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Caregivers (family or friend) of patients followed for a central neurological&#xD;
               pathology (MS, BM, Parkinson's, stroke, congenital (Spina...)) or peripheral&#xD;
               (ponytail, peripheral neuropathies)&#xD;
  &#xD;
            -  Adult caregivers (age ≥ 18 years), regardless of the patient's age&#xD;
  &#xD;
            -  Francophone caregivers (ability to read, write and understand French)&#xD;
  &#xD;
            -  Caregivers who did not object to the use of their data or the patient's data for&#xD;
               research&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  - Professional caregivers&#xD;
  &#xD;
            -  caregivers of patients being cared for with a pathology other than neurological&#xD;
  &#xD;
            -  Minor caregivers (age ≤ 17 years)&#xD;
  &#xD;
            -  Caregivers with no or poor French language skills&#xD;
  &#xD;
            -  Caregivers who refused to participate in the research&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>TURMEL Nicolas</last_name>
      <phone>0142356140</phone>
      <email>nicolas.turmel@ch-stdenis.fr</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</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>
  
  
text: 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/NCT05978245
  org study id: CHSD_0027_MPR
  nct id: NCT05978245
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  To validate the 2 questionnaires ZARIT-12 and CBI it is important to go through several
        stages:
  
          1. translation stage : during this stage there will be a meeting of experts to Validate the
             test version in French by 4 Bilingual translators of the French and English mother
             tongue.
  
          2. pilot stage : recruit a number of 30 neurological patients' caregivers, in order to
             validate the comprehension, thus obtaining the final version of the questionnaire.
  
          3. Validation stage : the two questionnaires have been validated, in this stage there
             should be a recruitment of 264 participants for the CBI questionnaire and 120
             participants for the ZARIT-12 questionnaire, and these 2 questionnaires will be deliver
             to the participant on the same day.
  
               -  The first questionnary will have to be filled the day they get the questionnary
                  (day 1).
  
               -  The second one must be completed and sent fourteen days later (day 14).
  To validate the 2 questionnaires ZARIT-12 and CBI it is important to go through several
        stages:
  
          1. translation stage : during this stage there will be a meeting of experts to Validate the
             test version in French by 4 Bilingual translators of the French and English mother
             tongue.
  
          2. pilot stage : recruit a number of 30 neurological patients' caregivers, in order to
             validate the comprehension, thus obtaining the final version of the questionnaire.
  
          3. Validation stage : the two questionnaires have been validated, in this stage there
             should be a recruitment of 264 participants for the CBI questionnaire and 120
             participants for the ZARIT-12 questionnaire, and these 2 questionnaires will be deliver
             to the participant on day 1. The first questionnary will have to be filled on day 1 and
             the second one must be completed and sent fourteen days later (so on day 14)
  observational model: Cohort
  time perspective: Prospective
  measure: French-language linguistic and cultural validation of caregiver burden questionnaires (Zarit-12) in a population of neurological patients
  time frame: two days (day one and day fourteen)
  description: ZARIT-12
  measure: French-language linguistic and cultural validation of caregiver burden questionnaires (CBI) in a population of neurological patients
  time frame: two days (day one and day fourteen)
  description: CBI questionnaire
  measure: Identifying populations at higher risk of burden
  time frame: two days (day one and day fourteen)
  description: ZARTI-2
  measure: Identifying populations at higher risk of burden
  time frame: two days (day one and day fourteen)
  description: CBI questionnaire
  measure: Identification of risk factors for caregiver's burden
  time frame: two days (day one and day fourteen)
  description: ZARIT-12
  measure: Identification of risk factors for caregiver's burden
  time frame: two days (day one and day fourteen)
  description: CBI questionnaire
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: No
  last name: TURMEL Nicolas
  phone: 0142356140
  email: nicolas.turmel@ch-stdenis.fr
  responsible party type: Sponsor