NCT07045363

Embedded Community-based Heart-Age Risk Education Trial in Cinese Primary Healthcare

Effectiveness of an Embedded Community-based Heart-Age Risk Education Model (E-CHARM) in Improving Cardiovascular Risk Awareness and Health Behaviors Among Older Adults With Hypertension: a Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Duke Kunshan University · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

This study evaluates the effectiveness of a brief Heart Age-based risk education intervention embedded in routine primary care for older adults with hypertension in China. The intervention uses routine health check data to generate a personalized one-page Heart Age report, delivered by physicians during regular follow-up visits. The trial tests whether this approach improves risk awareness and self-management behavior without disrupting clinical workflow.

Detailed description

This is a randomized controlled trial conducted a community health center in Kunshan, Jiangsu, China. Approximately 600 older adults (≥60 years) with hypertension will be recruited following completion of their national annual health check. Participants will be randomized 1:1 to receive either standard care or a Heart Age report with a brief scripted explanation delivered during their next follow-up consultation. The primary outcome is change in cardiovascular risk awareness at 3 months. Secondary outcomes include behavior change(measured by questionnaires); implementation outcomes (feasibility, acceptability, fidelity) will be measured in the intervention group. Clinical indicators (e.g., blood pressure, glucose) will be extracted from health records at 12 months as exploratory outcomes.

Conditions

• Hypertension

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Intervention	Participants in the intervention arm will receive a personalized one-page Heart Age report based on data from their government-funded annual health check. The report is delivered by trained physicians using a standardized communication script during a routine follow-up visit. The control group receives usual chronic disease care without structured risk communication.

Timeline

• Start date: 2025-07-19
• Primary completion: 2025-10-20
• Completion: 2026-07-20
• First posted: 2025-07-01
• Last updated: 2025-07-20

Locations

1 site across 1 country: China