<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/NCT03249467</url>
  </required_header>
  <id_info>
    <org_study_id>35RC16_3030_HAQ-II</org_study_id>
    <nct_id>NCT03249467</nct_id>
  </id_info>
  <brief_title>Validation of the French Version of the Health Assessment Questionnaire II (HAQ-II) for Rheumatoid Arthritis</brief_title>
  <acronym>HAQ-II</acronym>
  <official_title>Validation of the French Version of the Health Assessment Questionnaire II (HAQ-II) for Rheumatoid Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rennes University Hospital</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>
      The purpose of the study is to develop a validated French version of the HAQ-II questionnaire&#xD;
      for rheumatoid arthritis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The HAQ is the original Health Assessment Questionnaire used in rheumatology. It is available&#xD;
      in more than 60 languages and includes 42 items. However the questionnaire is not easy to use&#xD;
      in the clinic : complicated questions, long to answer for the patient and not easy to score&#xD;
      for the doctor.&#xD;
&#xD;
      The HAQ-II is a reliable and valid 10-item questionnaire that performs at least as well as&#xD;
      the HAQ and is simpler to administer and score. It includes 5 items already translated in&#xD;
      English and 5 new items not yet translated.&#xD;
&#xD;
      The aim of the study is the validation of the French version of the HAQ-II for rheumatoid&#xD;
      arthritis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 17, 2015</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Internal validity, scale HAQ-II</measure>
    <time_frame>Day 1</time_frame>
  </primary_outcome>
  <enrollment type="Actual">129</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with rheumatoid arthritis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient older than 18 years old&#xD;
&#xD;
          -  Patient with rheumatoid arthritis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU de Rennes</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>August 24, 2017</last_update_submitted>
  <last_update_submitted_qc>August 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HAQ-II</keyword>
  <keyword>Rheumatoid arthritis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</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/NCT03249467
org study id: 35RC16_3030_HAQ-II
nct id: NCT03249467
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to develop a validated French version of the HAQ-II questionnaire
      for rheumatoid arthritis.
The HAQ is the original Health Assessment Questionnaire used in rheumatology. It is available
      in more than 60 languages and includes 42 items. However the questionnaire is not easy to use
      in the clinic : complicated questions, long to answer for the patient and not easy to score
      for the doctor.

      The HAQ-II is a reliable and valid 10-item questionnaire that performs at least as well as
      the HAQ and is simpler to administer and score. It includes 5 items already translated in
      English and 5 new items not yet translated.

      The aim of the study is the validation of the French version of the HAQ-II for rheumatoid
      arthritis.
observational model: Case-Only
time perspective: Prospective
measure: Internal validity, scale HAQ-II
time frame: Day 1
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid