NCT03642795招募中不适用
Validation of the French Version of the CQR (Compliance Questionnaire Rheumatology): Specific Tool for Evaluation of Observance of Rheumatology Treatment
Centre Hospitalier Universitaire de Nīmes4 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年6月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Test-retest agreement of French translation of the Compliance Questionnaire Rheumatology questionnaire
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
结局指标
主要结局
Test-retest agreement of French translation of the Compliance Questionnaire Rheumatology questionnaire
时间窗: 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
时间窗: Baseline
Principal component analysis
次要结局
- 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)
研究者
研究点 (4)
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