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Recruiting NCT07628283

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

Conditions: Stroke, Brain Ischemia, Cerebral Hemorrhage, Transient Ischemic Attack, Cardiovascular Diseases, Hypertension

Sex: All
Ages: 65 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 2510
Sponsor: Jiangsu Province (Suqian) Hospital

Location: Jiangsu Province (Suqian)Hospital Suqian Jiangsu

Summary

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.

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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07628283). StuddyBuddy aggregates publicly available trial information.