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

Recruiting

• Conditions: Rheumatoid Polyarthritis

• Registration Number: NCT03642795
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-14
• Study First Submitted QC: 2018-08-20
• Study First Posted: 2018-08-22
• Study Start: 2022-06-23
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-31
• Last Update Posted: 2024-11-01
• Primary Completion: 2027-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Test-retest agreement of French translation of the Compliance Questionnaire Rheumatology questionnaire	40 minutes	Intraclass correlation and Kappa coefficient of 2 evaluations taken 40 minutes apart
Structural validity of French translation of the Compliance Questionnaire Rheumatology questionnaire	Baseline	Principal component analysis

Secondary Outcome Measures

Name	Time	Method
Rate of missing responses to each question of French translation of Compliance Questionnaire Rheumatology	Baseline
education level of observant versus non-observant patients	Month 1	school graduation
Sex of observant versus non-observant patients	Month 1	male/female
Number patients observing medication	Month 1	Blood MTX PG concentration nmol/L by LC-MS/MS
Compare French Compliance Questionnaire Rheumatology results against general questionnaire Morisky Medication Adherence Scale (MMAS-8)	Baseline	Sensitivity and specificity compared against MTX PGs level
Rate of questionnaires with at least 1 missing item	Baseline
Health-related quality of life in observant versus non-observant patients	Month 1	Euroqol 5 dimension 3 level questionnaire (EQ5D-3L)
Validation of the Compliance Questionnaire Rheumatology against gold standard (erythrocyte methotrexate polyglutamates (MTX PGs) concentration)	Baseline	CQR ≥80% (observant) vs MTX PGs level
Validation of the short form of the French Compliance Questionnaire Rheumatology	Baseline	5-item questionnaire
Age of observant versus non-observant patients	Month 1	years
profession of observant versus non-observant patients	Month 1	name of the profession
Quality of life in observant versus non-observant patients	Month 1	Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)
Functional incapacity in observant versus non-observant patients	Month 1	Health Assessment Questionnaire (HAQ)
Pain experience in observant versus non-observant patients	Month 1	Pain Catastrophizing Scale (PCS-CF)
Cognitive representations of medication in observant versus non-observant patients	Month 1	Beliefs about Medicines Questionnaire
marital status of observant versus non-observant patients	Month 1	Married, single, divorced, widowed

Trial Locations

Locations (4)

CHU Bordeaux; 🇫🇷 Bordeaux, France

CHRU Montpellier; 🇫🇷 Montpellier, France

CHU Nimes; 🇫🇷 Nîmes, France

CHU Toulouse; 🇫🇷 Toulouse, France