← Back to all trials
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
Source: ClinicalTrials.gov (NCT07628283). StuddyBuddy aggregates publicly available trial information.