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

NCT ID: NCT07045363

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-19
• Study Completion Date: 2026-07-20

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Usual Care (Control Group)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Heart Age Communication (Intervention Group)

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.

Group Type: EXPERIMENTAL

Cognitive Intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duke Kunshan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guanzhou Wang

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Tinglin Community Health Center

Suzhou, Jiangsu, China

Countries

China

Central Contacts

Yuxuan Huang

Role: CONTACT

yh368@duke.edu

86 18063279516

Guanzhou Wang

Role: CONTACT

gw122@duke.edu

86 15601200248

Facility Contacts

Ruwei Yuan, MD

Role: primary

guanzhouw@sina.com

+86 021-5738277

Other Identifiers

2025HC064

Identifier Type: -

Identifier Source: org_study_id