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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemedicine-Enabled Integrated Care Group | Experimental | 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. |
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| Enhanced Usual Care Group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced Usual Stroke Care | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| First Recurrent Stroke Event Rate at 36 Months | Time to first recurrent stroke (ischemic, hemorrhagic, or undetermined type) confirmed by CT/MRI imaging | 36 months |
| All-Cause Mortality at 36 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liu Qianghui Director of Suqian Hospital, Jiangsu Provincial People's Hospi | Contact | 15951598055 | jasonlion815@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suqian Hospital Affiliated to Jiangsu Provincial People's Hospital | Suqian | Jiangsu | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34877710 | Result | 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. |
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| Digital Health Platform-Supported Integrated Stroke Management | Behavioral | 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 |
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Death from any cause
| 36 months |
| Cardiovascular-Specific Mortality at 36 Months | Death due to cardiovascular causes including sudden cardiac death, myocardial infarction, heart failure, and stroke | 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 | 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 | 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 | Baseline, Month 12 |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002545 | Brain Ischemia |
| D002543 | Cerebral Hemorrhage |
| D002546 | Ischemic Attack, Transient |
| D002318 | Cardiovascular Diseases |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D020300 | Intracranial Hemorrhages |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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