Rheumatoid Polyarthritis
Conditions
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
Interventions
OTHERQuestionnaire
Patients are asked to complete several questionnaires
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Test-retest agreement of French translation of the Compliance Questionnaire Rheumatology questionnaire | 40 minutes | Intraclass correlation and Kappa coefficient of 2 evaluations taken 40 minutes apart |
| Structural validity of French translation of the Compliance Questionnaire Rheumatology questionnaire | Baseline | Principal component analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of questionnaires with at least 1 missing item | Baseline | % |
| Validation of the short form of the French Compliance Questionnaire Rheumatology | Baseline | 5-item questionnaire |
| Compare French Compliance Questionnaire Rheumatology results against general questionnaire Morisky Medication Adherence Scale (MMAS-8) | Baseline | Sensitivity and specificity compared against MTX PGs level |
| Sex of observant versus non-observant patients | Month 1 | male/female |
| Age of observant versus non-observant patients | Month 1 | years |
| education level of observant versus non-observant patients | Month 1 | school graduation |
| profession of observant versus non-observant patients | Month 1 | name of the profession |
| Validation of the Compliance Questionnaire Rheumatology against gold standard (erythrocyte methotrexate polyglutamates (MTX PGs) concentration) | Baseline | CQR ≥80% (observant) vs MTX PGs level |
| Number patients observing medication | Month 1 | Blood MTX PG concentration nmol/L by LC-MS/MS |
| Quality of life in observant versus non-observant patients | Month 1 | Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) |
| Health-related quality of life in observant versus non-observant patients | Month 1 | Euroqol 5 dimension 3 level questionnaire (EQ5D-3L) |
| Functional incapacity in observant versus non-observant patients | Month 1 | Health Assessment Questionnaire (HAQ) |
| Pain experience in observant versus non-observant patients | Month 1 | Pain Catastrophizing Scale (PCS-CF) |
| Cognitive representations of medication in observant versus non-observant patients | Month 1 | Beliefs about Medicines Questionnaire |
| marital status of observant versus non-observant patients | Month 1 | Married, single, divorced, widowed |
| Rate of missing responses to each question of French translation of Compliance Questionnaire Rheumatology | Baseline | % |
Countries
France
Contacts
Primary ContactCécile Gaujoux Viala, MD
Outcome results
None listed