A Cluster Randomized Trial of a Telemedicine-Enabled Integrated Care Model for Stroke Prevention and Management in Rural Elderly Adults in China
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
1 other identifier
interventional
2,510
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Jun 2026
Longer than P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
CompletedFirst Posted
Study publicly available on registry
June 5, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2030
June 5, 2026
May 1, 2026
3.6 years
May 28, 2026
May 28, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
36 months
Secondary Outcomes (6)
First Recurrent Stroke Event Rate at 36 Months
36 months
All-Cause Mortality at 36 Months
36 months
Cardiovascular-Specific Mortality at 36 Months
36 months
Hospitalization for Heart Failure or Acute Coronary Syndrome at 36 Months
36 months
Major Bleeding Events (ISTH Criteria) at 36 Months
36 months
- +1 more secondary outcomes
Study Arms (2)
Telemedicine-Enabled Integrated Care Group
EXPERIMENTALParticipants 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.
Enhanced Usual Care Group
ACTIVE COMPARATORParticipants 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.
Interventions
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.
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- Severe dementia or psychiatric disorder that prevents completion of study follow-up and assessments
- Life expectancy less than 1 year (e.g., advanced malignancy, end-stage renal disease)
- Currently participating in another interventional clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Suqian Hospital Affiliated to Jiangsu Provincial People's Hospital
Suqian, Jiangsu, China
Related Publications (1)
Hao R, Qi X, Xia X, Wang L, Li X. Malnutrition on admission increases the in-hospital mortality and length of stay in elder adults with acute ischemic stroke. J Clin Lab Anal. 2022 Jan;36(1):e24132. doi: 10.1002/jcla.24132. Epub 2021 Dec 8.
PMID: 34877710RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Liu Qianghui Director of Suqian Hospital, Jiangsu Provincial People's Hospi
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2026
First Posted
June 5, 2026
Study Start
June 1, 2026
Primary Completion (Estimated)
December 31, 2029
Study Completion (Estimated)
June 30, 2030
Last Updated
June 5, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share