An interventional study of Enhanced Usual Stroke Care and Digital Health Platform-Supported Integrated Stroke Management in Stroke, Brain Ischemia and Cerebral Hemorrhage, sponsored by Jiangsu Province (Suqian) Hospital. Recruiting at 2 sites in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Jiangsu Province (Suqian) Hospital · Not applicable, Interventional, and Prevention
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.
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.
Exclusion Criteria:
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.
Behavioral: Digital Health Platform-Supported Integrated Stroke Management
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.
Behavioral: Enhanced Usual Stroke Care
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.
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
Composite of Cardiovascular Death, Stroke, and Hospitalization for Heart Failure or Acute Coronary Syndrome at 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.
Time frame: 36 months
First Recurrent Stroke Event Rate at 36 Months
Time to first recurrent stroke (ischemic, hemorrhagic, or undetermined type) confirmed by CT/MRI imaging
Time frame: 36 months
All-Cause Mortality at 36 Months
Death from any cause
Time frame: 36 months
Cardiovascular-Specific Mortality at 36 Months
Death due to cardiovascular causes including sudden cardiac death, myocardial infarction, heart failure, and stroke
Time frame: 36 months
Hospitalization for Heart Failure or Acute Coronary Syndrome at 36 Months
Number of participants hospitalized for worsening heart failure or acute coronary syndrome
Time frame: 36 months
Major Bleeding Events (ISTH Criteria) at 36 Months
Number of participants experiencing major bleeding events as defined by the International Society on Thrombosis and Haemostasis (ISTH) criteria
Time frame: 36 months
Change in CHINA-PAR Score from Baseline to 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.
Time frame: Baseline, Month 12
Plan to share: No
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