Improvement in Patient Awareness and Ability to Assess Disease in Rheumatoid Arthritis: Rheumatoid Arthritis Through Education and US Study (RAEUS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 主要终点
- prevalence-adjusted bias adjusted kappa, PABAK>0.6
研究概览
简要总结
Patients can potentially monitor disease activity of rheumatoid arthritis (RA) through self-assessed swollen joints (clinical synovitis)joint counts but reliability of joint swelling is poor. The objective is to evaluate the use of education by ultrasound feedback on the ability of patients to assess for clinical synovitis swollen joints in RA.
详细描述
Design: 6-month single centre randomized controlled trial. Patients: established RA. Intervention: education on self-assessment of joints that included initial brief patient training on tender (TJC) and swollen (SJC) joint counts, followed by US feedback every 3 months versus standard care without education. Patient and physician independently performed 28-joint counts at each visit. Outcome variables: (Primary) Percentage of patients with good agreement with physician derived swollen joints (prevalence-adjusted bias adjusted kappa, PABAK>0.6). Other variables: Agreement in SJC (Bland and Altman 95% limits of agreement), feasibility/patient satisfaction survey and disease activity score (DAS28) at 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •RA patients fulfilling ACR1987 criteria
- •adults between age 21 and 80 years
排除标准
- •no mental health illness
- •fit to perform informed consent
结局指标
主要结局
prevalence-adjusted bias adjusted kappa, PABAK>0.6
时间窗: at 6 months
次要结局
- Bland and Altman 95% limits of agreement(6 months)
- Level of satisfaction(6 months)
- disease activity score in 28 joints (DAS28)(6 months)
研究者
Medicine
Dr Peter Cheung
National University Hospital, Singapore