A Novel Rural Integrated Care and Early Prevention Model for Older Adults at High Risk of or Living With Stroke in China
2026年8月24日 更新者：Jiangsu Province (Suqian) Hospital
A Prospective, Open-Label, Cluster Randomized Controlled Trial to Evaluate the Efficacy of a Rural Doctor-Led, Telemedicine-Supported Integrated Care Model for Reducing Cardiovascular and Cerebrovascular Events in Elderly Adults at High Risk of Stroke in China
This cluster randomized controlled trial aims to evaluate the effectiveness of a novel telemedicine-enabled integrated care model led by rural doctors in reducing cardiovascular and cerebrovascular events among elderly adults (≥65 years) at high risk of stroke in rural China.
A total of 39 village clinics will be randomized to either the intervention group (digital health platform-supported integrated care) or the control group (enhanced usual care).
The primary outcome is a composite of cardiovascular death, stroke, and hospitalization for heart failure or acute coronary syndrome at 36 months.
研究概览
地位
招聘中
详细说明
Stroke is the leading cause of death and disability in China, with a disproportionately higher burden in rural areas.
This study proposes a "technology-enabled, vertically integrated, pathway-integrated, performance-incentivized" care model to address the gaps in rural stroke management.
The intervention group will use a dedicated digital health platform (https://ricestroke.sqfh.org.cn:8421/gp/#/login) that provides clinical decision support, remote consultation with specialists, patient follow-up reminders, and performance feedback for rural doctors.
The control group will receive enhanced usual care without the digital platform.
The study will enroll 2510 participants and follow them for 36 months to assess the impact of the intervention on clinical outcomes, risk factor control, and medication adherence.
研究类型
介入性
注册 (估计的)
2510
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Liu Qianghui Director of Suqian Hospital, Jiangsu Provincial People's Hospi
- 电话号码：15951598055
- 邮箱：jasonlion815@163.com
学习地点
-
-
Jiangsu
-
Suqian、Jiangsu、中国
- 招聘中
- Jiangsu Province （Suqian）Hospital
-
接触：
- Zhao Jinxiang
- 电话号码：15862826785
- 邮箱：zhaojinxiang_ntu@163.com
-
Suqian、Jiangsu、中国
- 招聘中
- Suqian Hospital Affiliated to Jiangsu Provincial People's Hospital
-
接触：
- Zhao Jinxiang
- 电话号码：15862826785
- 邮箱：zhaojinxiang_ntu@163.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Aged 65 years or older
- Rural residents with household registration or long-term residence (≥6 months/year) in the study area
- High risk of stroke as defined by the National Health Commission's "8+2" stroke risk screening tool: ≥3 risk factors OR history of stroke/TIA
- Willing to receive long-term health management from the assigned village clinic
- Written informed consent provided by the participant or their legal representative
Exclusion Criteria:
- Severe dementia or psychiatric disorder that prevents completion of study follow-up and assessments
- Life expectancy less than 1 year (e.g., advanced malignancy, end-stage renal disease)
- Currently participating in another interventional clinical trial
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Telemedicine-Enabled Integrated Care Group
Participants receive care from rural doctors using a dedicated digital health support platform, including monthly monitoring, personalized medication adjustment, remote specialist consultation, and structured patient education.
|
Patient electronic health record management AI-powered clinical decision support for medication adjustment based on Chinese stroke guidelines Weekly remote video consultation with neurologists from tertiary hospitals Automated follow-up and medication adherence reminders Structured education and training for both rural doctors and patients
|
|
有源比较器：Enhanced Usual Care Group
Participants receive enhanced usual care from rural doctors who have received standardized training on stroke prevention and management, without the use of the digital health platform.
|
Rural doctors provide monthly face-to-face care based on national guidelines, including symptom monitoring, blood pressure measurement, medication guidance, and patient education.
Referrals to tertiary hospitals are made through conventional channels.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Composite of Cardiovascular Death, Stroke, and Hospitalization for Heart Failure or Acute Coronary Syndrome at 36 Months
大体时间：36 months
|
The primary composite endpoint includes: (1) cardiovascular death; (2) first occurrence of stroke (ischemic, hemorrhagic, or undetermined type); (3) hospitalization for worsening heart failure or acute coronary syndrome.
All events will be adjudicated by an independent clinical events committee blinded to treatment assignment.
|
36 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
First Recurrent Stroke Event Rate at 36 Months
大体时间：36 months
|
Time to first recurrent stroke (ischemic, hemorrhagic, or undetermined type) confirmed by CT/MRI imaging
|
36 months
|
|
All-Cause Mortality at 36 Months
大体时间：36 months
|
Death from any cause
|
36 months
|
|
Cardiovascular-Specific Mortality at 36 Months
大体时间：36 months
|
Death due to cardiovascular causes including sudden cardiac death, myocardial infarction, heart failure, and stroke
|
36 months
|
|
Hospitalization for Heart Failure or Acute Coronary Syndrome at 36 Months
大体时间：36 months
|
Number of participants hospitalized for worsening heart failure or acute coronary syndrome
|
36 months
|
|
Major Bleeding Events (ISTH Criteria) at 36 Months
大体时间：36 months
|
Number of participants experiencing major bleeding events as defined by the International Society on Thrombosis and Haemostasis (ISTH) criteria
|
36 months
|
|
Change in CHINA-PAR Score from Baseline to Month 12
大体时间：Baseline, Month 12
|
Change in 10-year ASCVD risk percentage as calculated by the CHINA-PAR risk prediction model in participants without prior stroke history Scale name: The output result is the 10-year ASCVD incidence risk percentage, in%, which is a continuous probability value. Theoretical range of values: Minimum value: 0%, representing no risk of ASCVD in the next 10 years; Maximum value: 100%, representing the inevitable occurrence of ASCVD in the next 10 years. The higher the score, the worse the result (higher risk). The scoring value directly corresponds to the probability of onset: the higher the value, the greater the probability of ASCVD events such as myocardial infarction, coronary heart disease death, and stroke occurring in the subject within the next 10 years, and the more severe the cardiovascular health risk; On the contrary, the lower the score, the lower the risk of onset and the better the cardiovascular prognosis. |
Baseline, Month 12
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年6月1日
初级完成 (估计的)
2029年12月31日
研究完成 (估计的)
2030年6月30日
研究注册日期
首次提交
2026年5月28日
首先提交符合 QC 标准的
2026年5月28日
首次发布 (实际的)
2026年6月5日
研究记录更新
最后更新发布 (实际的)
2026年8月26日
上次提交的符合 QC 标准的更新
2026年8月24日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.