Embedded Community-based Heart-Age Risk Education Trial in Cinese Primary Healthcare (E-CHARM)

Duke Kunshan University

Status: Not yet enrolling

Conditions: Hypertension

Treatments: Behavioral: Cognitive Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07045363

2025HC064

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults aged ≥60 years
• Diagnosed with hypertension
• Completed their government-funded annual health check within the past 3 months
• Scheduled for a routine follow-up consultation within the enrollment window -Able to provide informed consent-

Exclusion criteria

• Diagnosed dementia or severe cognitive impairment
• Terminal illness
• Participation in another clinical intervention trial

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

Usual Care (Control Group)

No Intervention group

Description:

Participants in this arm will receive standard hypertension management as per Chinese national guidelines, including regular follow-up with primary care physicians. They will not receive a Heart Age report or structured cardiovascular risk communication.

Heart Age Communication (Intervention Group)

Experimental group

Description:

Participants in this arm will receive a personalized Heart Age report based on their annual health check data (blood pressure, cholesterol, glucose, BMI, smoking). The report will be explained by the physician during the routine follow-up visit using a standardized script. The session lasts 3-5 minutes and is integrated into existing workflow.

Treatment:

Behavioral: Cognitive Intervention