Validation of a French version of a compliance questionnaire for rheumatology
Validation of the French Version of the CQR (Compliance Questionnaire Rheumatology): Specific Tool for Evaluation of Observance of Rheumatology Treatment
This study is testing a French version of a questionnaire to see how well it helps patients with rheumatoid arthritis understand and follow their methotrexate treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nīmes Academic / other |
| Drugs / interventions | Methotrexate |
| Locations | 4 sites (Bordeaux and 3 other locations) |
| Trial ID | NCT03642795 on ClinicalTrials.gov |
What this trial studies
This study aims to develop and validate a French language version of the Compliance Questionnaire Rheumatology (CQR) to be used in French-speaking rheumatology services. It involves collecting data from patients with rheumatoid polyarthritis who have been stable on methotrexate treatment. Participants will complete the questionnaire to assess their compliance with treatment. The results will help ensure that the questionnaire is culturally and linguistically appropriate for French-speaking populations.
Who should consider this trial
Good fit: Ideal candidates are French-speaking adults aged 18 and older with rheumatoid polyarthritis who have been on stable methotrexate treatment.
Not a fit: Patients who are not fluent in French or those who are currently participating in other interventional studies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the assessment of treatment compliance among French-speaking patients with rheumatoid polyarthritis.
How similar studies have performed: Other studies have successfully validated similar compliance questionnaires in different languages, indicating a positive precedent for this approach.
Eligibility criteria
Show full inclusion / exclusion 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 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).
Where this trial is running
Bordeaux and 3 other locations
- CHU Bordeaux — Bordeaux, France (Not_yet_recruiting)
- CHRU Montpellier — Montpellier, France (Not_yet_recruiting)
- CHU Nimes — Nîmes, France (Recruiting)
- CHU Toulouse — Toulouse, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Cécile Gaujoux Viala, MD
- Email: cecile.gaujoux.viala@chu-nimes.fr
- Phone: 04 66 68 31 20
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.