Brain Ischemia, Cardiovascular Diseases, Cerebral Hemorrhage, Hypertension, Stroke, Transient Ischemic Attack
Conditions
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.
Detailed 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.
Interventions
BEHAVIORALEnhanced Usual Stroke Care
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.
BEHAVIORALDigital Health Platform-Supported Integrated Stroke Management
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
Sponsors
Jiangsu Province (Suqian) Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of Cardiovascular Death, Stroke, and Hospitalization for Heart Failure or Acute Coronary Syndrome at 36 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| First Recurrent Stroke Event Rate at 36 Months | 36 months | Time to first recurrent stroke (ischemic, hemorrhagic, or undetermined type) confirmed by CT/MRI imaging |
| All-Cause Mortality at 36 Months | 36 months | Death from any cause |
| Cardiovascular-Specific Mortality at 36 Months | 36 months | Death due to cardiovascular causes including sudden cardiac death, myocardial infarction, heart failure, and stroke |
| Hospitalization for Heart Failure or Acute Coronary Syndrome at 36 Months | 36 months | Number of participants hospitalized for worsening heart failure or acute coronary syndrome |
| Major Bleeding Events (ISTH Criteria) at 36 Months | 36 months | Number of participants experiencing major bleeding events as defined by the International Society on Thrombosis and Haemostasis (ISTH) criteria |
| Change in CHINA-PAR Score from Baseline to Month 12 | Baseline, 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. |
Countries
China
Contacts
CONTACTLiu Qianghui Director of Suqian Hospital, Jiangsu Provincial People's Hospi
Outcome results
None listed