RecruitingNot Applicable

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

France150 participantsStarted 2022-06-23

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 40 minutes

Structural validity of French translation of the Compliance Questionnaire Rheumatology questionnaire

Timeframe: Baseline

Trial details

NCT IDNCT03642795

SponsorCentre Hospitalier Universitaire de Nīmes

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2029-03

Contact for this trial

Cécile Gaujoux Viala, MD

04 66 68 31 20 cecile.gaujoux.viala@chu-nimes.fr

View on ClinicalTrials.gov More Rheumatoid Polyarthritis trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.