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.
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
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
Parallel
Enhanced Usual Stroke Care
BehavioralRural 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.
Digital Health Platform-Supported Integrated Stroke Management
BehavioralPatient 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.
First Recurrent Stroke Event Rate at 36 Months
Time to first recurrent stroke (ischemic, hemorrhagic, or undetermined type) confirmed by CT/MRI imaging
All-Cause Mortality at 36 Months
Death from any cause
Cardiovascular-Specific Mortality at 36 Months
Death due to cardiovascular causes including sudden cardiac death, myocardial infarction, heart failure, and stroke
Hospitalization for Heart Failure or Acute Coronary Syndrome at 36 Months
Number of participants hospitalized for worsening heart failure or acute coronary syndrome
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