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

September 19, 2023 updated by: Centre Hospitalier Universitaire de Nīmes

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Bordeaux, France, 33000
      • Montpellier, France, 34295
        • Not yet recruiting
        • CHRU Montpellier
        • Contact:
        • Principal Investigator:
          • Jacques Morel, MD
      • Nîmes, France, 30029
        • Recruiting
        • Chu Nimes
        • Contact:
        • Principal Investigator:
          • Cécile Gaujoux Viala
      • Toulouse, France, 31300

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with rheumatoid polyarthritis
Other: Questionnaire
Patients are asked to complete several questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Structural validity of French translation of the Compliance Questionnaire Rheumatology questionnaire
Time Frame: Baseline
Principal component analysis
Baseline
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
40 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2022

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

November 14, 2017

First Submitted That Met QC Criteria

August 20, 2018

First Posted (Actual)

August 22, 2018

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 19, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHRCI/2016/CGV-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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