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RECRUITING Not applicable ClinicalTrials.gov

A Novel Rural Integrated Care and Early Prevention Model for Older Adults at High Risk of or Living With Stroke in China

Sponsor: Jiangsu Province (Suqian) Hospital • ClinicalTrials.gov ID: NCT07628283

Registry updated: 2026-08-26
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Description

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.

Interventions

  • Enhanced Usual Stroke Care (Behavioral)
    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.
  • Digital Health Platform-Supported Integrated Stroke Management (Behavioral)
    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

Eligibility criteria

Inclusion Criteria: 1. Aged 65 years or older 2. Rural residents with household registration or long-term residence (≥6 months/year) in the study area 3. 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 4. Willing to receive long-term health management from the assigned village clinic 5. Written informed consent provided by the participant or their legal representative Exclusion Criteria: 1. Severe dementia or psychiatric disorder that prevents completion of study follow-up and assessments 2. Life expectancy less than 1 year (e.g., advanced malignancy, end-stage renal disease) 3. Currently participating in another interventional clinical trial

Conditions

Stroke Brain Ischemia Cerebral Hemorrhage Transient Ischemic Attack Cardiovascular Diseases Hypertension

Locations

  • Jiangsu Province （Suqian）Hospital — Suqian, Jiangsu, China
  • Suqian Hospital Affiliated to Jiangsu Provincial People's Hospital — Suqian, Jiangsu, China
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record