Clinical trial NCT03642795: Validation of the French Version of the CQR (Compliance Questionnaire Rheumatology)
Official title: Validation of the French Version of the CQR (Compliance Questionnaire Rheumatology): Specific Tool for Evaluation of Observance of Rheumatology Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rheumatoid Polyarthritis
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2018-08-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with rheumatoid polyarthritis as defined by the ACR-EULAR 2010 criteria, treated orally or subcutaneously with MTX for at least 3 months being followed in the rheumatology department of Montpellier, Toulouse, Bordeaux or Nîmes hospitals.

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


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).

Primary outcomes:
measure: Test-retest agreement of French translation of the Compliance Questionnaire Rheumatology questionnaire
timeFrame: 40 minutes
measure: Structural validity of French translation of the Compliance Questionnaire Rheumatology questionnaire
timeFrame: Baseline
Secondary outcomes:
measure: Validation of the Compliance Questionnaire Rheumatology against gold standard (erythrocyte methotrexate polyglutamates (MTX PGs) concentration)
timeFrame: Baseline
measure: Rate of missing responses to each question of French translation of Compliance Questionnaire Rheumatology
timeFrame: Baseline
measure: Rate of questionnaires with at least 1 missing item
timeFrame: Baseline
measure: Validation of the short form of the French Compliance Questionnaire Rheumatology
timeFrame: Baseline
measure: Compare French Compliance Questionnaire Rheumatology results against general questionnaire Morisky Medication Adherence Scale (MMAS-8)
timeFrame: Baseline
measure: Sex of observant versus non-observant patients
timeFrame: Month 1
measure: Age of observant versus non-observant patients
timeFrame: Month 1
measure: education level of observant versus non-observant patients
timeFrame: Month 1
measure: profession of observant versus non-observant patients
timeFrame: Month 1
measure: marital status of observant versus non-observant patients
timeFrame: Month 1
measure: Number patients observing medication
timeFrame: Month 1
measure: Quality of life in observant versus non-observant patients
timeFrame: Month 1
measure: Health-related quality of life in observant versus non-observant patients
timeFrame: Month 1
measure: Functional incapacity in observant versus non-observant patients
timeFrame: Month 1
measure: Pain experience in observant versus non-observant patients
timeFrame: Month 1
measure: Cognitive representations of medication in observant versus non-observant patients
timeFrame: Month 1
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Montpellier
country: France
facility: CHRU Montpellier
city: Nîmes
country: France
facility: CHU Nimes
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
References: