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NCT Number: NCT07045363

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

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.

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Key information

Conditions

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

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in cardiovascular disease (CVD) risk awareness

    Time frame: 3 months

    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.

Secondary outcomes

  1. Change in physical activity level

    Time frame: 3 months

    Change in self-reported physical activity level, measured using an 11-level categorical scale developed for this study and adapted from the WHO Stepwise approach. Responses range from 1 (completely inactive) to 11 (vigorous activity >25 miles/week or >8 hours/week). Higher scores indicate greater physical activity level.

  2. Change in dietary behavior: fruit intake

    Time frame: 3 months

    Change in self-reported fruit consumption frequency, measured by the question: "On how many days per week do you usually eat fruit?" (0-7 days). Higher values indicate higher frequency of fruit intake.

  3. Change in dietary behavior: table salt use

    Time frame: 3 months

    Change in self-reported table salt use, measured by a single item adapted from the WHO STEPS questionnaire: "Do you usually add salt or salty condiments (e.g., soy sauce) at the table?" Responses on a 5-point scale: 1 = Always, 5 = Never. Higher scores indicate lower frequency of adding table salt.

  4. Change in medication adherence

    Time frame: 3 months

    Change in self-reported medication adherence, assessed using the Morisky Medication Adherence Scale, 4-item version (MMAS-4). Each item scored as Yes = 1, No = 0, for a total score range of 0-4. Lower scores indicate better medication adherence.

  5. Implementation outcomes 1: Feasibility (intervention group only)

    Time frame: 3 months

    Measured using the Feasibility of Intervention Measure (FIM), 4 items, each scored on a 5-point Likert scale (1 = Strongly disagree, 5 = Strongly agree). Higher scores indicate greater perceived feasibility.

  6. Implementation outcomes 2: Acceptability (intervention group only)

    Time frame: 3 months

    Measured using the Acceptability of Intervention Measure (AIM), 4 items, each scored on a 5-point Likert scale (1 = Strongly disagree, 5 = Strongly agree). Higher scores indicate greater acceptability.

  7. Implementation outcomes 3: Fidelity (intervention group only)

    Time frame: 3 months

    Assessed using patient-reported and provider-reported delivery checks with categorical response options (e.g., explained fully, partially, not explained).

Other outcomes

  1. Change in systolic blood pressure

    Time frame: 12 months

    Mean change in systolic blood pressure (mmHg) extracted from routine health records.

  2. Change in diastolic blood pressure

    Time frame: 12 months

    Mean change in diastolic blood pressure (mmHg) extracted from routine health records.

  3. Change in body mass index (BMI)

    Time frame: 12 months

    Mean change in body mass index (BMI, kg/m²) extracted from routine health records.

  4. Change in fasting plasma glucose

    Time frame: 12 months

    Mean change in fasting plasma glucose level (mmol/L) extracted from routine health records.

  5. Change in total cholesterol

    Time frame: 12 months

    Mean change in total cholesterol level (mmol/L) extracted from routine health records.

  6. Change in low-density lipoprotein cholesterol (LDL-C)

    Time frame: 12 months

    Mean change in low-density lipoprotein cholesterol (LDL-C, mmol/L) extracted from routine health records.

  7. Change in high-density lipoprotein cholesterol (HDL-C)

    Time frame: 12 months

    Mean change in high-density lipoprotein cholesterol (HDL-C, mmol/L) extracted from routine health records.

  8. Change in triglycerides

    Time frame: 12 months

    Mean change in triglyceride level (mmol/L) extracted from routine health records.

Study contacts

Contact information is provided by the study sponsor or research team.

Guanzhou Wang

CONTACT

[email protected]

86 15601200248

Yuxuan Huang

CONTACT

[email protected]

86 18063279516

Sponsors and collaborators

Lead sponsor

Duke Kunshan University

Other

Registry information

Official study title

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

Acronym: E-CHARM

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 1, 2025
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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