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

Centre Hospitalier Universitaire de Nīmes4 sites in 1 country150 target enrollmentJune 23, 2022

ConditionsRheumatoid Polyarthritis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Rheumatoid Polyarthritis
Sponsor: Centre Hospitalier Universitaire de Nīmes
Enrollment: 150
Locations: 4
Primary Endpoint: Test-retest agreement of French translation of the Compliance Questionnaire Rheumatology questionnaire
Status: Recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

June 23, 2022

End Date

March 1, 2029

Last Updated

5 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Centre Hospitalier Universitaire de Nīmes

Responsible Party

Sponsor

Eligibility 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).

Outcomes

Primary Outcomes

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

Structural validity of French translation of the Compliance Questionnaire Rheumatology questionnaire

Time Frame: Baseline

Principal component analysis

Secondary Outcomes

Validation of the Compliance Questionnaire Rheumatology against gold standard (erythrocyte methotrexate polyglutamates (MTX PGs) concentration)(Baseline)
Rate of missing responses to each question of French translation of Compliance Questionnaire Rheumatology(Baseline)
Rate of questionnaires with at least 1 missing item(Baseline)
Validation of the short form of the French Compliance Questionnaire Rheumatology(Baseline)
Compare French Compliance Questionnaire Rheumatology results against general questionnaire Morisky Medication Adherence Scale (MMAS-8)(Baseline)
Sex of observant versus non-observant patients(Month 1)
Age of observant versus non-observant patients(Month 1)
education level of observant versus non-observant patients(Month 1)
profession of observant versus non-observant patients(Month 1)
marital status of observant versus non-observant patients(Month 1)
Number patients observing medication(Month 1)
Quality of life in observant versus non-observant patients(Month 1)
Health-related quality of life in observant versus non-observant patients(Month 1)
Functional incapacity in observant versus non-observant patients(Month 1)
Pain experience in observant versus non-observant patients(Month 1)
Cognitive representations of medication in observant versus non-observant patients(Month 1)