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

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…

ClinicalTrials.gov IDNCT07628283

PhaseNA

Enrollment2510

SponsorJiangsu Province (Suqian) Hospital

Age65 Years

SexALL

I'm interested View official listing

Conditions studied

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

About this study

Interventions

Behavioral: Enhanced Usual Stroke Care — 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.
Behavioral: Digital Health Platform-Supported Integrated Stroke Management — 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

Primary outcomes

Composite of Cardiovascular Death, Stroke, and Hospitalization for Heart Failure or Acute Coronary Syndrome at 36 Months (36 months)

Eligibility information

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

Study locations

Jiangsu Province （Suqian）Hospital, Suqian, Jiangsu China
Suqian Hospital Affiliated to Jiangsu Provincial People's Hospital, Suqian, Jiangsu China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-01.