A Cluster Randomized Trial of a Telemedicine-Enabled Integrated Care Model for Stroke Prevention and Management in Rural Elderly Adults in China

Jiangsu Province (Suqian) Hospital

Status: Not yet enrolling

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

Treatments: Behavioral: Enhanced Usual Stroke Care; Behavioral: Digital Health Platform-Supported Integrated Stroke Management

Study type: Interventional

Funder types: Other

Identifiers

NCT07628283

RICE-STROKE-2026-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2,510 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

2,510 participants in 2 patient groups

Telemedicine-Enabled Integrated Care Group

Experimental group

Description:

Participants receive care from rural doctors using a dedicated digital health support platform, including monthly monitoring, personalized medication adjustment, remote specialist consultation, and structured patient education.

Treatment:

Behavioral: Digital Health Platform-Supported Integrated Stroke Management

Enhanced Usual Care Group

Active Comparator group

Description:

Participants receive enhanced usual care from rural doctors who have received standardized training on stroke prevention and management, without the use of the digital health platform.

Treatment:

Behavioral: Enhanced Usual Stroke Care