<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/NCT02977325</url>
  </required_header>
  <id_info>
    <org_study_id>CHU-0293</org_study_id>
    <nct_id>NCT02977325</nct_id>
  </id_info>
  <brief_title>Validation of the Questionnaire ASES</brief_title>
  <acronym>ASES</acronym>
  <official_title>Translation and Cultural Adaptation of the Arthritis Self-Efficacy Scale</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Clermont Communauté</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Innovatherm</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</source>
  <brief_summary>
    <textblock>
      Questionnaires are often irreplaceable tools of collection of information in research and in&#xD;
      the clinical practice. Coupled with other measures, they can be simple complementary tools,&#xD;
      but questionnaires are sometimes the only way to collect data, such as self-service efficacy.&#xD;
&#xD;
      The objective of this study is a validation of the French translation of the ASES. To&#xD;
      guarantee the comparability between the original version and the translated version, the&#xD;
      translation of a questionnaire supposes two essential stages: a literal translation and an&#xD;
      adaptation to the cultural context, to the habits of life and to the idioms of the target&#xD;
      population. This new version will afterward be validated with patient's troop.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators are particularly interested in the Arthritis Self-Efficacy Scale (ASES),&#xD;
      conceived to highlight a change of the faith of the patients in their capacities to make&#xD;
      usual thinks or behaviour in front of consequences of the degenerative osteoarthritis,&#xD;
      further to a therapeutic education.&#xD;
&#xD;
      The ASES is an auto-questionnaire compound of 20 items, from 0 to 10 on a digital scale and&#xD;
      distributed in three domains: control of the pain (on 50), function (on 90) and other&#xD;
      symptoms (on 60).&#xD;
&#xD;
      This questionnaire was already translated into Swedish, Dutch and Turkish.&#xD;
&#xD;
      Translation of the ASES and cultural adaptation :&#xD;
&#xD;
      The translation of the ASES in French followed the recommendations of the literature, which&#xD;
      recommend a double translation, then a double back - translation with synthesis of the data&#xD;
      in every stage. A final commission deliberate then a final translation, culturally adapted.&#xD;
&#xD;
      Patients' cohort and procedure of validation :&#xD;
&#xD;
      The prospective validation will be made with patients affected by degenerative osteoarthritis&#xD;
      who fill the questionnaire ASES. These patients arose from cures of three thermal&#xD;
      establishments of Auvergne. One group participated in therapeutic programs centered on the&#xD;
      physical activity; the other one followed exclusively the water cure and received at the end&#xD;
      of the cure an explanatory notebook on the degenerative osteoarthritis with physical&#xD;
      exercises centered on the muscular strengthening of lower limbs.&#xD;
&#xD;
      Feedback :&#xD;
&#xD;
      Assessments conducted by the using of self - questionnaires:&#xD;
&#xD;
      - Sent by mail to the patients and back at 3 and 3,5 months&#xD;
&#xD;
      Ethics:&#xD;
&#xD;
      A written consent was collected before inclusion in the study and a document intended for the&#xD;
      information was given to the patient. The study is anonymous, indeed, index forms will be&#xD;
      coded before IT processing to guarantee the anonymity of the patient.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2015</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>personal efficacy by means of the French questionnaire ASES &quot;Arthritis Self-Efficacy Scale&quot;</measure>
    <time_frame>at 3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>personal efficacy by means of the French questionnaire ASES &quot;Arthritis Self-Efficacy Scale&quot;</measure>
    <time_frame>at 3 months +15 days</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <condition>Physical Activity</condition>
  <condition>Education</condition>
  <condition>Self-management</condition>
  <condition>Exercise</condition>
  <arm_group>
    <arm_group_label>Physical activity</arm_group_label>
    <description>One group participated in therapeutic programs centered on the physical activity</description>
  </arm_group>
  <arm_group>
    <arm_group_label>water cure exclusively</arm_group_label>
    <description>This group followed exclusively the water cure</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>water cure</intervention_name>
    <arm_group_label>Physical activity</arm_group_label>
    <arm_group_label>water cure exclusively</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with knee osteoarthritis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria :&#xD;
&#xD;
        Both sexes, 50-75 years old Knee osteoarthritis Patients affiliated to a social security&#xD;
        scheme Patients realizing a Spa Therapy Acceptance to participate in the study&#xD;
&#xD;
        Exclusion criteria :&#xD;
&#xD;
        &lt; 50-year-old patients or &gt; 75 years Inflammatory, tumoral, traumatic or infectious&#xD;
        rheumatism Cardiac decompensation Disorders of the concentration or the compression of the&#xD;
        written or oral French language.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emmanuel COUDEYRE</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Clermont-Ferrand</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>December 2, 2016</last_update_submitted>
  <last_update_submitted_qc>December 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Physical activity level</keyword>
  <keyword>Personal efficacy</keyword>
  <keyword>Knee osteoarthritis</keyword>
  <keyword>Self-management</keyword>
  <keyword>Self-care</keyword>
  <keyword>Education and exercise in knee osteoarthritis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</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/NCT02977325
org study id: CHU-0293
nct id: NCT02977325
lead sponsor: 
collaborator: 
collaborator: 
Questionnaires are often irreplaceable tools of collection of information in research and in
      the clinical practice. Coupled with other measures, they can be simple complementary tools,
      but questionnaires are sometimes the only way to collect data, such as self-service efficacy.

      The objective of this study is a validation of the French translation of the ASES. To
      guarantee the comparability between the original version and the translated version, the
      translation of a questionnaire supposes two essential stages: a literal translation and an
      adaptation to the cultural context, to the habits of life and to the idioms of the target
      population. This new version will afterward be validated with patient's troop.
The investigators are particularly interested in the Arthritis Self-Efficacy Scale (ASES),
      conceived to highlight a change of the faith of the patients in their capacities to make
      usual thinks or behaviour in front of consequences of the degenerative osteoarthritis,
      further to a therapeutic education.

      The ASES is an auto-questionnaire compound of 20 items, from 0 to 10 on a digital scale and
      distributed in three domains: control of the pain (on 50), function (on 90) and other
      symptoms (on 60).

      This questionnaire was already translated into Swedish, Dutch and Turkish.

      Translation of the ASES and cultural adaptation :

      The translation of the ASES in French followed the recommendations of the literature, which
      recommend a double translation, then a double back - translation with synthesis of the data
      in every stage. A final commission deliberate then a final translation, culturally adapted.

      Patients' cohort and procedure of validation :

      The prospective validation will be made with patients affected by degenerative osteoarthritis
      who fill the questionnaire ASES. These patients arose from cures of three thermal
      establishments of Auvergne. One group participated in therapeutic programs centered on the
      physical activity; the other one followed exclusively the water cure and received at the end
      of the cure an explanatory notebook on the degenerative osteoarthritis with physical
      exercises centered on the muscular strengthening of lower limbs.

      Feedback :

      Assessments conducted by the using of self - questionnaires:

      - Sent by mail to the patients and back at 3 and 3,5 months

      Ethics:

      A written consent was collected before inclusion in the study and a document intended for the
      information was given to the patient. The study is anonymous, indeed, index forms will be
      coded before IT processing to guarantee the anonymity of the patient.
time perspective: Prospective
measure: personal efficacy by means of the French questionnaire ASES "Arthritis Self-Efficacy Scale"
time frame: at 3 months
measure: personal efficacy by means of the French questionnaire ASES "Arthritis Self-Efficacy Scale"
time frame: at 3 months +15 days
arm group label: Physical activity
description: One group participated in therapeutic programs centered on the physical activity
arm group label: water cure exclusively
description: This group followed exclusively the water cure
intervention type: Other
intervention name: water cure
arm group label: Physical activity
arm group label: water cure exclusively
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: 70 Years
healthy volunteers: No
last name: Emmanuel COUDEYRE
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
facility: 
country: France
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee