Ignite Creation Date:
2025-12-24 @ 2:09 PM
Ignite Modification Date:
2026-02-20 @ 8:27 PM
Study NCT ID:
NCT03642795
Status:
RECRUITING
Last Update Posted:
2025-12-03
First Post:
2017-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of the French Version of the CQR (Compliance Questionnaire Rheumatology)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2029-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2017-11-14', 'studyFirstSubmitQcDate': '2018-08-20', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Test-retest agreement of French translation of the Compliance Questionnaire Rheumatology questionnaire', 'timeFrame': '40 minutes', 'description': 'Intraclass correlation and Kappa coefficient of 2 evaluations taken 40 minutes apart'}, {'measure': 'Structural validity of French translation of the Compliance Questionnaire Rheumatology questionnaire', 'timeFrame': 'Baseline', 'description': 'Principal component analysis'}], 'secondaryOutcomes': [{'measure': 'Validation of the Compliance Questionnaire Rheumatology against gold standard (erythrocyte methotrexate polyglutamates (MTX PGs) concentration)', 'timeFrame': 'Baseline', 'description': 'CQR ≥80% (observant) vs MTX PGs level'}, {'measure': 'Rate of missing responses to each question of French translation of Compliance Questionnaire Rheumatology', 'timeFrame': 'Baseline', 'description': '%'}, {'measure': 'Rate of questionnaires with at least 1 missing item', 'timeFrame': 'Baseline', 'description': '%'}, {'measure': 'Validation of the short form of the French Compliance Questionnaire Rheumatology', 'timeFrame': 'Baseline', 'description': '5-item questionnaire'}, {'measure': 'Compare French Compliance Questionnaire Rheumatology results against general questionnaire Morisky Medication Adherence Scale (MMAS-8)', 'timeFrame': 'Baseline', 'description': 'Sensitivity and specificity compared against MTX PGs level'}, {'measure': 'Sex of observant versus non-observant patients', 'timeFrame': 'Month 1', 'description': 'male/female'}, {'measure': 'Age of observant versus non-observant patients', 'timeFrame': 'Month 1', 'description': 'years'}, {'measure': 'education level of observant versus non-observant patients', 'timeFrame': 'Month 1', 'description': 'school graduation'}, {'measure': 'profession of observant versus non-observant patients', 'timeFrame': 'Month 1', 'description': 'name of the profession'}, {'measure': 'marital status of observant versus non-observant patients', 'timeFrame': 'Month 1', 'description': 'Married, single, divorced, widowed'}, {'measure': 'Number patients observing medication', 'timeFrame': 'Month 1', 'description': 'Blood MTX PG concentration nmol/L by LC-MS/MS'}, {'measure': 'Quality of life in observant versus non-observant patients', 'timeFrame': 'Month 1', 'description': 'Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)'}, {'measure': 'Health-related quality of life in observant versus non-observant patients', 'timeFrame': 'Month 1', 'description': 'Euroqol 5 dimension 3 level questionnaire (EQ5D-3L)'}, {'measure': 'Functional incapacity in observant versus non-observant patients', 'timeFrame': 'Month 1', 'description': 'Health Assessment Questionnaire (HAQ)'}, {'measure': 'Pain experience in observant versus non-observant patients', 'timeFrame': 'Month 1', 'description': 'Pain Catastrophizing Scale (PCS-CF)'}, {'measure': 'Cognitive representations of medication in observant versus non-observant patients', 'timeFrame': 'Month 1', 'description': 'Beliefs about Medicines Questionnaire'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Polyarthritis']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient must have given their free and informed consent and signed the consent form\n* The patient must be a member or beneficiary of a health insurance plan\n* The patient is at least 18 years old\n* 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\n\nExclusion Criteria:\n\n* The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study\n* The subject refuses to sign the consent\n* It is impossible to give the subject informed information\n* The patient is under safeguard of justice or state guardianship\n* The subject has a contraindication to taking methotrexate (including a patient with a desire to become pregnant).'}, 'identificationModule': {'nctId': 'NCT03642795', 'acronym': 'CQR-F', 'briefTitle': 'Validation of the French Version of the CQR (Compliance Questionnaire Rheumatology)', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Validation of the French Version of the CQR (Compliance Questionnaire Rheumatology): Specific Tool for Evaluation of Observance of Rheumatology Treatment', 'orgStudyIdInfo': {'id': 'PHRCI/2016/CGV-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with rheumatoid polyarthritis', 'interventionNames': ['Other: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'Patients are asked to complete several questionnaires', 'armGroupLabels': ['Patients with rheumatoid polyarthritis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33000', 'city': 'Bordeaux', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Christophe Richez, MD', 'role': 'CONTACT', 'email': 'christophe.richez@chu-bordeaux.fr'}, {'name': 'Christophe Richez, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '34295', 'city': 'Montpellier', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jacques Morel, MD', 'role': 'CONTACT', 'email': 'j-morel@chu-montpellier.fr'}, {'name': 'Jacques Morel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHRU Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '30029', 'city': 'Nîmes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anissa Megzari', 'role': 'CONTACT', 'email': 'drc@chu-nimes.fr', 'phone': '04.66.68.42.36'}, {'name': 'Cécile Gaujoux Viala', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Nimes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '31300', 'city': 'Toulouse', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Arnaud Constantin', 'role': 'CONTACT', 'email': 'arnaud.constantin@univ-tlse3.fr'}, {'name': 'Arnaud Constantin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Cécile Gaujoux Viala, MD', 'role': 'CONTACT', 'email': 'cecile.gaujoux.viala@chu-nimes.fr', 'phone': '04 66 68 31 20'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}