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Validation of the French Version of the CQR (Compliance Questionnaire Rheumatology) (CQR-F)

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ClinicalTrials.gov Identifier: NCT03642795
Recruitment Status : Not yet recruiting
First Posted : August 22, 2018
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Brief Summary:
The purpose of this study is to develop a French language version of the Compliance-Questionnaire-Rheumatology for use in French and Francophone rheumatology services

Condition or disease Intervention/treatment
Rheumatoid Polyarthritis Other: Questionnaire

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Validation of the French Version of the CQR (Compliance Questionnaire Rheumatology): Specific Tool for Evaluation of Observance of Rheumatology Treatment
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : August 2021

Group/Cohort Intervention/treatment
Patients with rheumatoid polyarthritis Other: Questionnaire
Patients are asked to complete several questionnaires




Primary Outcome Measures :
  1. Test-retest agreement of French translation of the Compliance Questionnaire Rheumatology questionnaire [ Time Frame: 3 hours ]
    Intraclass correlation and Kappa coefficient of 2 evaluations taken 3 hours apart

  2. Structural validity of French translation of the Compliance Questionnaire Rheumatology questionnaire [ Time Frame: Baseline ]
    Principal component analysis


Secondary Outcome Measures :
  1. Validation of the Compliance Questionnaire Rheumatology against gold standard (erythrocyte methotrexate polyglutamates (MTX PGs) concentration) [ Time Frame: Baseline ]
    CQR ≥80% (observant) vs MTX PGs level

  2. Rate of missing responses to each question of French translation of Compliance Questionnaire Rheumatology [ Time Frame: Baseline ]
  3. Rate of questionnaires with at least 1 missing item [ Time Frame: Baseline ]
  4. Validation of the short form of the French Compliance Questionnaire Rheumatology [ Time Frame: Baseline ]
    5-item questionnaire

  5. Compare French Compliance Questionnaire Rheumatology results against general questionnaire Morisky Medication Adherence Scale (MMAS-8) [ Time Frame: Baseline ]
    Sensitivity and specificity compared against MTX PGs level

  6. Sex of observant versus non-observant patients [ Time Frame: Month 1 ]
    male/female

  7. Age of observant versus non-observant patients [ Time Frame: Month 1 ]
    years

  8. education level of observant versus non-observant patients [ Time Frame: Month 1 ]
    school graduation

  9. profession of observant versus non-observant patients [ Time Frame: Month 1 ]
    name of the profession

  10. marital status of observant versus non-observant patients [ Time Frame: Month 1 ]
    Married, single, divorced, widowed

  11. Number patients observing medication [ Time Frame: Month 1 ]
    Blood MTX PG concentration nmol/L by LC-MS/MS

  12. Quality of life in observant versus non-observant patients [ Time Frame: Month 1 ]
    Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)

  13. Health-related quality of life in observant versus non-observant patients [ Time Frame: Month 1 ]
    Euroqol 5 dimension 3 level questionnaire (EQ5D-3L)

  14. Functional incapacity in observant versus non-observant patients [ Time Frame: Month 1 ]
    Health Assessment Questionnaire (HAQ)

  15. Pain experience in observant versus non-observant patients [ Time Frame: Month 1 ]
    Pain Catastrophizing Scale (PCS-CF)

  16. Cognitive representations of medication in observant versus non-observant patients [ Time Frame: Month 1 ]
    Beliefs about Medicines Questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with rheumatoid polyarthritis as defined by the ACR-EULAR 2010 criteria, treated orally or subcutaneously with MTX for at least 3 months being followed in the rheumatology department of Montpellier, Toulouse, Bordeaux or Nîmes hospitals.
Criteria

Inclusion Criteria:

  • The patient must have given their free and informed consent and signed the consent form
  • The patient must be a member or beneficiary of a health insurance plan
  • The patient is at least 18 years old
  • The patient has rheumatoid polyarthritis as defined by the ACR-EULAR 2010 criteria, treated orally or subcutaneously with MTX for at least 3 months. Other treatments at the same time are authorized

Exclusion Criteria:

  • The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
  • The subject refuses to sign the consent
  • It is impossible to give the subject informed information
  • The patient is under safeguard of justice or state guardianship
  • The subject has a contraindication to taking methotrexate (including a patient with a desire to become pregnant).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03642795


Contacts
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Contact: Cécile Gaujoux Viala, MD 04 66 68 31 20 cecile.gaujoux.viala@chu-nimes.fr

Locations
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France
CHU Bordeaux Not yet recruiting
Bordeaux, France, 33000
Contact: Christophe Richez, MD       christophe.richez@chu-bordeaux.fr   
Principal Investigator: Christophe Richez, MD         
CHRU Montpellier Not yet recruiting
Montpellier, France, 34295
Contact: Jacques Morel, MD       j-morel@chu-montpellier.fr   
Principal Investigator: Jacques Morel, MD         
CHU Nimes Not yet recruiting
Nîmes, France, 30029
Contact: Anissa Megzari    04.66.68.42.36    drc@chu-nimes.fr   
Principal Investigator: Cécile Gaujoux Viala         
CHU Toulouse Not yet recruiting
Toulouse, France, 31300
Contact: Arnaud Constantin       arnaud.constantin@univ-tlse3.fr   
Principal Investigator: Arnaud Constantin, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes

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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT03642795     History of Changes
Other Study ID Numbers: PHRCI/2016/CGV-01
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Joint Diseases
Musculoskeletal Diseases