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NCT07628283Recruiting

A Novel Rural Integrated Care and Early Prevention Model for Older Adults at High Risk of or Living With Stroke 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

Source: ClinicalTrials.gov · Last updated 26 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
2510 (estimated)
First submitted
28 May 2026
Start date
1 Jun 2026
Primary completion date
31 Dec 2029
Lead sponsor
Jiangsu Province (Suqian) Hospital
NCT number
NCT07628283

What you commit to

  • Study type: Interventional
  • Planned participants: 2510
  • From 1 Jun 2026 to the primary completion date, 31 Dec 2029
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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)

Other

  • Currently participating in another interventional clinical trial

Who the study is looking for

  • 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

Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Jiangsu Province (Suqian)Hospital
Coordinator of this site? Confirm its status
SuqianChinaRecruiting
Suqian Hospital Affiliated to Jiangsu Provincial People's Hospital
Coordinator of this site? Confirm its status
SuqianChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.