COmprehensive Management of High-risk PopuLatIon for Stroke bAsed oN soCial nEtwork: A Multicenter Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 720
- 试验地点
- 1
- 主要终点
- Patient's medication adherence to five evidence-based secondary prevention drugs for stroke at 12 months after discharge
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of social network in improving drug compliance and risk factors control rate of stroke high-risk population after discharge.
详细描述
Stroke is the leading cause of death among residents in China, with the characteristics of high morbidity, high mortality, high disability rate, high recurrence rate and so on, which brings huge economic burden to the patients' families and society. Strengthening the comprehensive management of the high-risk population of stroke, improving the medication compliance of patients and the control rate of stroke risk factors play a key role in reducing stroke recurrence.
This study is a multicenter, prospective, randomized, single-blind study, which aims to use the tool of WeChat Mini Programs to realize the post-hospital follow-up management of the high-risk population of stroke. The follow-up time is 12 months. The main measurement result was the change of patients' medication compliance after comprehensive management.
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)
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
- •Age ≥18 years.
- •Hospitalized patients at high risk of stroke are those who have at least three of the following risk factors: hypertension, dyslipidemia, diabetes, atrial fibrillation/valvular disease, smoking history, overweight/obesity, physical inactivity, or family stroke history; or those with a history of prior transient ischemic attack (TIA) or stroke.12
- •modified Rankin Scale (mRS) score ≤
- •Smartphone/WeChat access (patient or caregiver).
- •Informed consent obtained.
- •Active long-term therapy: ≥1 medication (antihypertensive, hypoglycemic, lipid-lowering, anticoagulant, antiplatelet).
排除标准
- •Inability to operate smartphones (patient or caregiver).
- •Comorbidities potentially confounding outcome assessments, including Advanced malignancies (life expectancy <12 months); Documented dementia; Severe psychiatric disorders (e.g., schizophrenia, major depressive disorder).
- •Residence in areas with unreliable internet access.
- •Concurrent participation in other clinical trials.
- •Any condition deemed by investigators to preclude safe trial participation.
结局指标
主要结局
Patient's medication adherence to five evidence-based secondary prevention drugs for stroke at 12 months after discharge
时间窗: 12 months after discharge
Compliance is defined when patients take all evidence-based secondary preventive drugs (antihypertensive, hypoglycemic, lipid-regulating, anticoagulant and antiplatelet drugs) for more than 24 days in 12 months after discharge, that is, the drug taking rate is \> 80% (\> 24/30 days). If the patient adjusts the drug or stops taking the drug by himself, it will be regarded as "non-compliance". If the patient stops taking the drug according to the doctor's advice, it will be regarded as compliance. If the drug is adjusted according to the doctor's advice, it is necessary to continue to ask about the number of days of taking the drug in the past month. If the number of days of taking the drug exceeds 24 days, it will be regarded as compliance.
次要结局
- Stroke health behavior improvement(1 month, 3 months, 6 months and 12 months after discharge)
- Health-related quality of life(1 month, 3 months, 6 months and 12 months after discharge)
- Self efficacy(1 month, 3 months, 6 months and 12 months after discharge)
- Knowledge of stroke(1 month, 3 months, 6 months and 12 months after discharge)
- Incidence of anxiety(1 month, 3 months, 6 months and 12 months after discharge)
- Incidence of depression(1 month, 3 months, 6 months and 12 months after discharge)
- The attainment rate of stroke risk factors (blood glucose, blood pressure, blood lipid, BMI, waist circumference, hip circumference, smoking) at 1 month, 3 months, 6 months and 12 months after discharge.(1 month, 3 months, 6 months and 12 months after discharge)
- Personal motivation(1 month, 3 months, 6 months and 12 months after discharge)
- Social motivation(1 month, 3 months, 6 months and 12 months after discharge)
- The rate of good compliance with stroke prevention drugs among patients 1 month, 3 months, 6 months and 12 months after discharge(1 month, 3 months，6 months and 12 months after discharge.)
- Incidence of major cardiovascular events including stroke, acute coronary syndrome, and vascular death(1 month, 3 months, 6 months and 12 months after discharge)