The Treat-to-target Study of Rheumatoid Arthritis Based on Smart System of Disease Management(SSDM) : A Randomized Controlled Multicenter Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 2,200
- 试验地点
- 1
- 主要终点
- The rate of T2T between the two groups.
研究概览
简要总结
This study evaluate the Smart System of Disease Management（SSDM）to improve the treat-to-target(T2T) and the safety of drug in the treatment of rheumatoid(RA). All participants will be randomized in the SSDM group and the control group. The patients in the SSDM group will use the SSDM every month and the control group will receive the conventional therapy.
详细描述
Treat-to-Target (T2T), achieving a DAS28 score lower than 2.6 (remission, Rem) or below 3.2 (low disease activity, LDA), is the main management strategy recommended by ACR and EULAR. The Smart System of Disease Management (SSDM) is an interactive mobile disease management tool, including the doctors' and patients' application system. The patients can perform self-evaluation, including DAS28, morning stiffness duration (MSD) and HAQ, and input medical records (including medication and laboratory test results) through the mobile application. The data synchronizes to the mobiles of authorized rheumatologists through cloud data base and advices could be delivered.
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
- Single (Investigator)
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
- •Clinical diagnosis of Rheumatoid Arthritis.
- •Have a smartphone
- •Must be able to access disease activity by themselves
排除标准
- •Not able to access disease activity by themselves
- •Lacks the ability of self-management
- •Mental disorders or severe physical dysfunction
- •Extremely poor compliance
结局指标
主要结局
The rate of T2T between the two groups.
时间窗: six month
Self-reported data was reported at baseline and every month until the sixth month in the SSDM group and the patients only reported their disease at baseline and the sixth month in the control group.
次要结局
- The rate of T2T between the two groups.(twelve month)
- The relapse rate between the two groups(Six month and twelve month)
- The safety of drug use between the two groups(Six month and twelve month)
- The medical economics between the two groups(Six month and twelve month)
- The numbers of active intervention by doctors between the two groups(Six month and twelve month)
- The HADS between the two groups(Six month and twelve month)
- The compliance between the two groups(Six month and twelve month)
- The effect of active intervention by doctors between the two groups(Six month and twelve month)
- The SF-36 between the two groups(Six month and twelve month)