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NCT Number: NCT03642795

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

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

Recruiting

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Key information

Conditions

Rheumatoid Polyarthritis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Bordeaux, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 with a stable (unchanged) dosage for at least 1 month, and a stable (unchanged) route of administration for at least 1 month. And no planned change in Methotrexate intake at least until the second study visit. 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).

Treatment and study plan

Questionnaire

Other

Patients are asked to complete several questionnaires

Primary outcomes

  1. Test-retest agreement of French translation of the Compliance Questionnaire Rheumatology questionnaire

    Time frame: 40 minutes

    Intraclass correlation and Kappa coefficient of 2 evaluations taken 40 minutes apart

  2. Structural validity of French translation of the Compliance Questionnaire Rheumatology questionnaire

    Time frame: Baseline

    Principal component analysis

Secondary outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Cécile Gaujoux Viala, MD

CONTACT

[email protected]

04 66 68 31 20

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Validation of the French Version of the CQR (Compliance Questionnaire Rheumatology): Specific Tool for Evaluation of Observance of Rheumatology Treatment

Acronym: CQR-F

Important dates

Study start
2022
Primary completion
2029
Study completion
2029
First posted
Aug 22, 2018
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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