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Recruiting NCT03642795

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

— Observational Rheumatoid Polyarthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Questionnaire.
Who it may be relevant to
Registry conditions: Rheumatoid Polyarthritis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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

Interventions

  • Other Questionnaire
    Patients are asked to complete several questionnaires

Primary outcome measures

  • Test-retest agreement of French translation of the Compliance Questionnaire Rheumatology questionnaire [Time frame: 40 minutes]
  • Structural validity of French translation of the Compliance Questionnaire Rheumatology questionnaire [Time frame: Baseline]
Secondary outcome measures (12)
  • Validation of the Compliance Questionnaire Rheumatology against gold standard (erythrocyte methotrexate polyglutamates (MTX PGs) concentration) [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 [Time frame: Baseline]
  • Compare French Compliance Questionnaire Rheumatology results against general questionnaire Morisky Medication Adherence Scale (MMAS-8) [Time frame: Baseline]
  • Sex of observant versus non-observant patients [Time frame: Month 1]
  • Age of observant versus non-observant patients [Time frame: Month 1]
  • education level of observant versus non-observant patients [Time frame: Month 1]
  • profession of observant versus non-observant patients [Time frame: Month 1]
  • marital status of observant versus non-observant patients [Time frame: Month 1]
  • Number patients observing medication [Time frame: Month 1]
  • Quality of life in observant versus non-observant patients [Time frame: Month 1]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

France · 4 centers
  • CHU Bordeaux — Bordeaux
  • CHRU Montpellier — Montpellier
  • CHU Nimes — Nîmes
  • CHU Toulouse — Toulouse

Identifiers

NCT: NCT03642795 · PHRCI/2016/CGV-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗