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
Sponsor: Jiangsu Province (Suqian) Hospital
Trial Details
| Condition | Stroke, Brain Ischemia, Cerebral Hemorrhage, Transient Ischemic Attack, Cardiovascular Diseases, Hypertension |
| Intervention | Enhanced Usual Stroke Care; Digital Health Platform-Supported Integrated Stroke Management |
| Phase | NA |
| Status | Not_yet_recruiting |
| Participants | 2,510 |
| Est. Completion | 31 Dec 2029 |
| Last Updated | 5 June 2026 |
Primary Outcome
Composite of Cardiovascular Death, Stroke, and Hospitalization for Heart Failure or Acute Coronary Syndrome at 36 Months
Eligibility Criteria
Inclusion 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
Trial Sites
Countries
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