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

Centre Hospitalier Universitaire de Nīmes150 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Rheumatoid Polyarthritis

Interventions

QuestionnaireOTHER

Patients are asked to complete several questionnaires

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (4)

CHU Bordeaux

Bordeaux, France

NOT_YET_RECRUITING

CHRU Montpellier

Montpellier, France

NOT_YET_RECRUITING

CHU Nimes

Nîmes, France

RECRUITING

CHU Toulouse

Outcomes

Primary Outcomes

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

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

Time frame: 40 minutes

Structural validity of French translation of the Compliance Questionnaire Rheumatology questionnaire

Principal component analysis

Time frame: Baseline

Secondary Outcomes

Validation of the Compliance Questionnaire Rheumatology against gold standard (erythrocyte methotrexate polyglutamates (MTX PGs) concentration)

CQR ≥80% (observant) vs MTX PGs level

Time frame: Baseline

Rate of missing responses to each question of French translation of Compliance Questionnaire Rheumatology

Time frame: Baseline

Rate of questionnaires with at least 1 missing item

Time frame: Baseline

Validation of the short form of the French Compliance Questionnaire Rheumatology

5-item questionnaire

Time frame: Baseline

Compare French Compliance Questionnaire Rheumatology results against general questionnaire Morisky Medication Adherence Scale (MMAS-8)

Sensitivity and specificity compared against MTX PGs level

Time frame: Baseline

Sex of observant versus non-observant patients

Central Contacts

Cécile Gaujoux Viala, MD

CONTACT

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

Data from ClinicalTrials.gov

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