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

NCT07045363 | Not Yet Recruiting

• 1 other identifier: 2025HC064
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Heart Age; Health education

Outcome Measures

Primary Outcomes (1)

• Change in cardiovascular disease (CVD) risk awareness

  assessed using a 10-item CVD Knowledge Questionnaire adapted from the Chinese version of the Cardiovascular Disease Attitudes and Beliefs Questionnaire (ABCD-C) and the Heart Disease Fact Questionnaire (HDFQ). Each item is scored as 1 (correct) or 0 (incorrect/Don't know), yielding a total score range from 0 to 10. Higher scores indicate greater knowledge and awareness of CVD risk factors.

  3 months

Secondary Outcomes (7)

• Change in physical activity level

  3 months

• Change in dietary behavior: fruit intake

  3 months

• Change in dietary behavior: table salt use

  3 months

• Change in medication adherence

  3 months

• Implementation outcomes 1: Feasibility (intervention group only)

  3 months

Other Outcomes (8)

• Change in systolic blood pressure

  12 months

• Change in diastolic blood pressure

  12 months

• Change in body mass index (BMI)

  12 months

Study Arms (2)

Usual Care (Control Group)

NO INTERVENTION

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

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.

Behavioral: Cognitive Intervention

Interventions

Cognitive Intervention 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.

Heart Age Communication (Intervention Group)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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-

You may not qualify if:

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

Sponsors & Collaborators

• Duke Kunshan University: lead

Study Sites (1)

Tinglin Community Health Center

Suzhou, Jiangsu, 215316, China

Location

MeSH Terms

Conditions

Hypertension; Health Education

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Guanzhou Wang

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuxuan Huang

CONTACT

86 18063279516; yh368@duke.edu

Guanzhou Wang

CONTACT

86 15601200248; gw122@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: July 1, 2025
• Study Start: July 19, 2025
• Primary Completion: October 20, 2025
• Study Completion (Estimated): July 20, 2026
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)