StrokeNCT07628283
A Novel Rural Integrated Care and Early Prevention Model for Older Adults at High Risk of or Living With Stroke in China
A study testing Enhanced Usual Stroke Care and Digital Health Platform-Supported Integrated Stroke Management in people with Stroke and Brain Ischemia, run by Jiangsu Province (Suqian) Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Stroke, Brain Ischemia, Cerebral Hemorrhage
- What is being tested?
- Enhanced Usual Stroke Care and Digital Health Platform-Supported Integrated Stroke Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,510 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jun 2026to 30 Jun 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Liu Qianghui Director of Suqian Hospital, Jiangsu Provincial People's Hospi contact
China2 sites, 2 recruiting
- Recruiting
Jiangsu Province （Suqian）Hospital
Suqian, Jiangsu
Zhao Jinxiang, 15862826785, zhaojinxiang_ntu@163.com
- Recruiting
Suqian Hospital Affiliated to Jiangsu Provincial People's Hospital
Suqian, Jiangsu
Zhao Jinxiang, 15862826785, zhaojinxiang_ntu@163.com
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Stroke, Brain Ischemia, Cerebral Hemorrhage, Transient Ischemic Attack, Cardiovascular Diseases, Hypertension
- Being tested
- Enhanced Usual Stroke Care, Digital Health Platform-Supported Integrated Stroke Management
- Medical subject headings
- Stroke, Brain Ischemia, Cerebral Hemorrhage, Ischemic Attack, Transient, Cardiovascular Diseases, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Usual Stroke CareBehavioural
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.
Digital Health Platform-Supported Integrated Stroke ManagementBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Digital Health Platform-Supported Integrated Stroke Management |
| 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. Receives: Behavioral: Enhanced Usual Stroke Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 months
Secondary outcomes (6)
First Recurrent Stroke Event Rate at 36 Months
Time to first recurrent stroke (ischemic, hemorrhagic, or undetermined type) confirmed by CT/MRI imaging
Measured: 36 months
All-Cause Mortality at 36 Months
Death from any cause
Measured: 36 months
Cardiovascular-Specific Mortality at 36 Months
Death due to cardiovascular causes including sudden cardiac death, myocardial infarction, heart failure, and stroke
Measured: 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
Measured: 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
Measured: 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 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.
Measured: Baseline, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start1 Jun 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,510 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province (Suqian) Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07628283
- Sponsor's protocol ID
- RICE-STROKE-2026-001
- Status last verified
- Jul 2026
- First submitted
- 28 May 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34877710