System-integrated Technology-enabled Model of Care to Improve the Health of Stroke Patients in Rural China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,299
- 试验地点
- 1
- 主要终点
- systolic blood pressure
研究概览
简要总结
Despite the significant burden of stroke in rural China, secondary prevention of stroke is scarce. The aim of the study is to develop a system-integrated technology-enabled intervention (SINEMA) model for the secondary prevention of stroke in rural China and evaluate the effectiveness of the model compared with usual care. The hypothesis is that trained village doctors, equipped with digital health technology, can provide essential evidence-based care to stroke survivors in rural China.
详细描述
The SINEMA trial is a cluster-randomized controlled trial to evaluate the effectiveness of implementation of a system-integrated and technology-enabled model of care to improve the secondary prevention of stroke in Nanhe County, a rural area of Hebei province, China. Fifty villages from five townships are stratified randomized in a 1:1 ratio to either the intervention arm (implementing SINEMA model) or the control arm (usual care).
After a baseline survey, intervention will be implemented in 25 intervention villages, lasting for 12 months. Follow-up survey will be conducted in the same way in all villages at 12-month after the initial of the study. Process evaluation will be conducted every three month, and economic evaluation will also be conducted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes assessors (staffs from a nearby county) are masked with no information on which villages will be assigned to intervention group or control group.
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
- •are aged more than 18 years old;
- •have a history of stroke (including ischemic and hemorrhagic stroke) diagnosed at county hospital or higher-level facilities, and currently in a clinically stable condition and not receiving acute stroke treatment;
- •will live in this village for at least nine months during the next 12 months;
- •have a basic communication ability (i.e. can understand simple instructions);
- •give participant informed consent and are willing to participate in the study.
排除标准
- •are unable to get out of bed without maximum assistance;
- •have serious life-threatening disease such as cancers;
- •who have an expected life span of less than 6 months.
结局指标
主要结局
systolic blood pressure
时间窗: change from baseline to 12-month of follow-up
change in systolic blood pressure
次要结局
- mobility(change from baseline to 12-month of follow-up)
- medication adherence(change from baseline to 12-month of follow-up)
- physical activity level(change from baseline to 12-month of follow-up)
- health related quality of life(change from baseline to 12-month of follow-up)
- diastolic blood pressure(change from baseline to 12-month of follow-up)