A Cluster Randomized Trial of a Telemedicine-Enabled Integrated Care Model for Stroke Prevention … (NCT07628283) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Cluster Randomized Trial of a Telemedicine-Enabled Integrated Care Model for Stroke Prevention and Management in Rural Elderly Adults in China
China2,510 participantsStarted 2026-06-01
Plain-language 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.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. Severe dementia or psychiatric disorder that prevents completion of study follow-up and assessments
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Composite of Cardiovascular Death, Stroke, and Hospitalization for Heart Failure or Acute Coronary Syndrome at 36 Months
Timeframe: 36 months
Trial details
NCT IDNCT07628283
SponsorJiangsu Province (Suqian) Hospital
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2029-12-31
Contact for this trial
Liu Qianghui Director of Suqian Hospital, Jiangsu Provincial People's Hospi