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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with rheumatoid polyarthritis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire | Other | Patients are asked to complete several questionnaires |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Structural validity of French translation of the Compliance Questionnaire Rheumatology questionnaire | Principal component analysis | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Validation of the Compliance Questionnaire Rheumatology against gold standard (erythrocyte methotrexate polyglutamates (MTX PGs) concentration) | CQR ≥80% (observant) vs MTX PGs level | Baseline |
| Rate of missing responses to each question of French translation of Compliance Questionnaire Rheumatology |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cécile Gaujoux Viala, MD | Contact | 04 66 68 31 20 | cecile.gaujoux.viala@chu-nimes.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Bordeaux | Not yet recruiting | Bordeaux | 33000 | France |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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% |
| Baseline |
| Rate of questionnaires with at least 1 missing item | % | Baseline |
| Validation of the short form of the French Compliance Questionnaire Rheumatology | 5-item questionnaire | Baseline |
| Compare French Compliance Questionnaire Rheumatology results against general questionnaire Morisky Medication Adherence Scale (MMAS-8) | Sensitivity and specificity compared against MTX PGs level | Baseline |
| Sex of observant versus non-observant patients | male/female | Month 1 |
| Age of observant versus non-observant patients | years | Month 1 |
| education level of observant versus non-observant patients | school graduation | Month 1 |
| profession of observant versus non-observant patients | name of the profession | Month 1 |
| marital status of observant versus non-observant patients | Married, single, divorced, widowed | Month 1 |
| Number patients observing medication | Blood MTX PG concentration nmol/L by LC-MS/MS | Month 1 |
| Quality of life in observant versus non-observant patients | Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) | Month 1 |
| Health-related quality of life in observant versus non-observant patients | Euroqol 5 dimension 3 level questionnaire (EQ5D-3L) | Month 1 |
| Functional incapacity in observant versus non-observant patients | Health Assessment Questionnaire (HAQ) | Month 1 |
| Pain experience in observant versus non-observant patients | Pain Catastrophizing Scale (PCS-CF) | Month 1 |
| Cognitive representations of medication in observant versus non-observant patients | Beliefs about Medicines Questionnaire | Month 1 |
| CHRU Montpellier | Not yet recruiting | Montpellier | 34295 | France |
|
| CHU Nimes | Recruiting | Nîmes | 30029 | France |
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| CHU Toulouse | Not yet recruiting | Toulouse | 31300 | France |
|
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |