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

Jiangsu Province (Suqian) Hospital2,510 enrolled

Overview

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.

Stroke is the leading cause of death and disability in China, with a disproportionately higher burden in rural areas. This study proposes a "technology-enabled, vertically integrated, pathway-integrated, performance-incentivized" care model to address the gaps in rural stroke management. The intervention group will use a dedicated digital health platform (https://ricestroke.sqfh.org.cn:8421/gp/#/login) that provides clinical decision support, remote consultation with specialists, patient follow-up reminders, and performance feedback for rural doctors. The control group will receive enhanced usual care without the digital platform. The study will enroll 2510 participants and follow them for 36 months to assess the impact of the intervention on clinical outcomes, risk factor control, and medication adherence.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

2,510

Conditions

Stroke

Interventions

Enhanced Usual Stroke CareBEHAVIORAL

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 ManagementBEHAVIORAL

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

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

The primary composite endpoint includes: (1) cardiovascular death; (2) first occurrence of stroke (ischemic, hemorrhagic, or undetermined type); (3) hospitalization for worsening heart failure or acute coronary syndrome. All events will be adjudicated by an independent clinical events committee blinded to treatment assignment.

Time frame: 36 months

Secondary Outcomes

First Recurrent Stroke Event Rate at 36 Months

Time to first recurrent stroke (ischemic, hemorrhagic, or undetermined type) confirmed by CT/MRI imaging

Time frame: 36 months

All-Cause Mortality at 36 Months

Death from any cause

Time frame: 36 months

Cardiovascular-Specific Mortality at 36 Months

Death due to cardiovascular causes including sudden cardiac death, myocardial infarction, heart failure, and stroke

Time frame: 36 months

Hospitalization for Heart Failure or Acute Coronary Syndrome at 36 Months

Number of participants hospitalized for worsening heart failure or acute coronary syndrome

Time frame: 36 months

Major Bleeding Events (ISTH Criteria) at 36 Months

Number of participants experiencing major bleeding events as defined by the International Society on Thrombosis and Haemostasis (ISTH) criteria

Time frame: 36 months

Change in CHINA-PAR Score from Baseline to Month 12

Change in 10-year ASCVD risk percentage as calculated by the CHINA-PAR risk prediction model in participants without prior stroke history Scale name: The output result is the 10-year ASCVD incidence risk percentage, in%, which is a continuous probability value. Theoretical range of values: Minimum value: 0%, representing no risk of ASCVD in the next 10 years; Maximum value: 100%, representing the inevitable occurrence of ASCVD in the next 10 years. The higher the score, the worse the result (higher risk). The scoring value directly corresponds to the probability of onset: the higher the value, the greater the probability of ASCVD events such as myocardial infarction, coronary heart disease death, and stroke occurring in the subject within the next 10 years, and the more severe the cardiovascular health risk; On the contrary, the lower the score, the lower the risk of onset and the better the cardiovascular prognosis.

Time frame: Baseline, Month 12

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

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts