Evaluation of the Usefulness of a Center Specialized in the Standardized Management of Rheumatoid Arthritis: The COMEDRA Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 970
- 试验地点
- 2
- 主要终点
- Comorbidities treatment
研究概览
简要总结
The two objectives of this trial are :1 To evaluate the impact of a visit with a nurse checking the preventive modalities and/or the presence of comorbidities such as infections ( e.g. vaccinations), cardiovascular-diseases (e.g. Indication to statin, antiaggregant,anti-hypertensive treatment…), cancers (e.g.mammography,…), osteoporosis (e.g. bone densitometry,..) in patients suffering from Rheumatoid Arthritis 2 To evaluate the impact of an educational program aimed at permitting rheumatoid arthritis patients to auto-evaluate their disease activity by collecting the Disease Activity Score (DAS28-ESR).
详细描述
Patients with a stable definite Rheumatoid Arthritis will be invited by their rheumatologists to participate at this study in 20 centers in France. After written informed consent will be obtained, the patients will be randomized in two arms:
- comorbidities
- auto-DAS The patients will be seen again in the same center six months later in order to collect the outcome measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Rheumatoid Arthritis
- •Stable (no change in therapy)
- •Able to collaborate
- •Exclusion criteria
- •Pregnant woman
- •Change of the therapy for 3 months before the inclusion
- •Alcoholism, toxicomania, psychological problem, sever co morbidity which could invalid the consent or limit the protocol compliance
- •No social coverage affiliate
排除标准
- 未提供
结局指标
主要结局
Comorbidities treatment
时间窗: 6 months later
Number of actions initiated I order to treat or prevent Rheumatoid Arthritis comorbidities
Auto-DAS: Patient education to calculate his Disease Activity Score
时间窗: 6 months after
Number of patients with a modification in their treatment between baseline and 6 months visits
次要结局
- Frequency of comorbidities in Rheumatoid Arthritis(6 months later)
- Adhesion to the current recommendations concerning the prevention of co-morbidities(6 months later)
- Compliance and satisfaction of the patients concerning the DAS educational program(6 months later)