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

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

Sponsors

Lead sponsor: Centre Hospitalier Universitaire de Nīmes

Source Centre Hospitalier Universitaire de Nīmes
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

Overall Status Not yet recruiting
Start Date January 2020
Completion Date August 2021
Primary Completion Date July 2021
Study Type Observational
Primary Outcome
Measure Time Frame
Test-retest agreement of French translation of the Compliance Questionnaire Rheumatology questionnaire 3 hours
Structural validity of French translation of the Compliance Questionnaire Rheumatology questionnaire Baseline
Secondary Outcome
Measure Time Frame
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
Enrollment 150
Condition
Intervention

Intervention type: Other

Intervention name: Questionnaire

Description: Patients are asked to complete several questionnaires

Arm group label: Patients with rheumatoid polyarthritis

Eligibility

Sampling method: Non-Probability Sample

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. 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).

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Contact

Last name: Cécile Gaujoux Viala, MD

Phone: 04 66 68 31 20

Email: [email protected]

Location
facility contact investigator
CHU Bordeaux | Bordeaux, 33000, France Christophe Richez, MD [email protected] Christophe Richez, MD Principal Investigator
CHRU Montpellier | Montpellier, 34295, France Jacques Morel, MD [email protected] Jacques Morel, MD Principal Investigator
CHU Nimes | Nîmes, 30029, France Anissa Megzari 04.66.68.42.36 [email protected] Cécile Gaujoux Viala Principal Investigator
CHU Toulouse | Toulouse, 31300, France Arnaud Constantin [email protected] Arnaud Constantin, MD Principal Investigator
Location Countries

France

Verification Date

July 2019

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Patients with rheumatoid polyarthritis

Acronym CQR-F
Study Design Info

Observational model: Case-Only

Time perspective: Prospective

Source: ClinicalTrials.gov