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

Rheumatoid Polyarthritis Clinical Trial

— CQR-F  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03642795
• Other study ID #: PHRCI/2016/CGV-01
• Status: Recruiting
• Start date: June 23, 2022
• Est. completion date: September 2027

Study information

• Verified date: September 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Cécile Gaujoux Viala, MD
• Phone: 04 66 68 31 20
• Email: cecile.gaujoux.viala[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2027
• Est. primary completion date: September 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Arthritis
• Rheumatoid Polyarthritis

Intervention

Other:
• Questionnaire
Patients are asked to complete several questionnaires

Locations

Country	Name	City	State
France	CHU Bordeaux	Bordeaux
France	CHRU Montpellier	Montpellier
France	CHU Nimes	Nîmes
France	CHU Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test-retest agreement of French translation of the Compliance Questionnaire Rheumatology questionnaire	Intraclass correlation and Kappa coefficient of 2 evaluations taken 40 minutes apart	40 minutes
Primary	Structural validity of French translation of the Compliance Questionnaire Rheumatology questionnaire	Principal component analysis	Baseline
Secondary	Validation of the Compliance Questionnaire Rheumatology against gold standard (erythrocyte methotrexate polyglutamates (MTX PGs) concentration)	CQR =80% (observant) vs MTX PGs level	Baseline
Secondary	Rate of missing responses to each question of French translation of Compliance Questionnaire Rheumatology		Baseline
Secondary	Rate of questionnaires with at least 1 missing item		Baseline
Secondary	Validation of the short form of the French Compliance Questionnaire Rheumatology	5-item questionnaire	Baseline
Secondary	Compare French Compliance Questionnaire Rheumatology results against general questionnaire Morisky Medication Adherence Scale (MMAS-8)	Sensitivity and specificity compared against MTX PGs level	Baseline
Secondary	Sex of observant versus non-observant patients	male/female	Month 1
Secondary	Age of observant versus non-observant patients	years	Month 1
Secondary	education level of observant versus non-observant patients	school graduation	Month 1
Secondary	profession of observant versus non-observant patients	name of the profession	Month 1
Secondary	marital status of observant versus non-observant patients	Married, single, divorced, widowed	Month 1
Secondary	Number patients observing medication	Blood MTX PG concentration nmol/L by LC-MS/MS	Month 1
Secondary	Quality of life in observant versus non-observant patients	Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)	Month 1
Secondary	Health-related quality of life in observant versus non-observant patients	Euroqol 5 dimension 3 level questionnaire (EQ5D-3L)	Month 1
Secondary	Functional incapacity in observant versus non-observant patients	Health Assessment Questionnaire (HAQ)	Month 1
Secondary	Pain experience in observant versus non-observant patients	Pain Catastrophizing Scale (PCS-CF)	Month 1
Secondary	Cognitive representations of medication in observant versus non-observant patients	Beliefs about Medicines Questionnaire	Month 1