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A Prospective, Open-Label, Cluster Randomized Controlled Trial to Evaluate the Efficacy of a Rural Doctor-Led, Telemedicine-Supported Integrated Care Model for Reducing Cardiovascular and Cerebrovascular Events in Elderly Adults at High Risk of Stroke in China

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• Aged 65 years or older

• Rural residents with household registration or long-term residence (≥6 months/year) in the study area

• 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

• Willing to receive long-term health management from the assigned village clinic

• Written informed consent provided by the participant or their legal representative

Locations
Other Locations
China
Jiangsu Province (Suqian)Hospital
RECRUITING
Suqian
Suqian Hospital Affiliated to Jiangsu Provincial People's Hospital
RECRUITING
Suqian
Contact Information
Primary
Liu Qianghui Director of Suqian Hospital, Jiangsu Provincial People's Hospi
jasonlion815@163.com
15951598055
Time Frame
Start Date: 2026-06-01
Estimated Completion Date: 2030-06-30
Participants
Target number of participants: 2510
Treatments
Experimental: Telemedicine-Enabled Integrated Care Group
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.
Active_comparator: Enhanced Usual Care Group
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.
Sponsors
Leads: Jiangsu Province (Suqian) Hospital

This content was sourced from clinicaltrials.gov