A Cluster Randomized Trial of a Telemedicine-Enabled Integrated Care Model for Stroke Prevention and Management in Rural Elderly Adults in China

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorJiangsu Province (Suqian) Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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 design

Treatments tested in this trial

  • Enhanced Usual Stroke Care
  • Digital Health Platform-Supported Integrated Stroke Management

Treatment groups

2,510 Participants
are divided into 2 treatment groups