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Completed

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

Tinglin Community Health Center

Suzhou, Jiangsu, 215316, China

About this study

This is a randomized controlled trial conducted at a community health center in Kunshan, Jiangsu, China. A total of 358 adults aged 60 years or older with hypertension were randomized 1:1 to receive either usual care or a personalized Heart Age report with a brief scripted physician explanation delivered during the routine consultation in which participants received and discussed their annual health-check results. The primary outcome is cardiovascular risk awareness at 3 months. Secondary outcomes include self-reported physical activity and dietary behaviors. Implementation outcomes, including feasibility, acceptability, fidelity, and consultation burden, are assessed primarily in the intervention group. Clinical indicators, including blood pressure, glucose, lipids, and body mass index, are obtained from routine health records at approximately 12 months as exploratory outcomes.

An exploratory four-item medication-taking questionnaire based on the Morisky-Green-Levine measure (Morisky et al., 1986) was administered at baseline. Responses were coded Yes = 1 and No = 0, with higher scores indicating more non-adherent responses. The measure was previously misidentified in the registry as the MMAS-4. The planned follow-up assessment of medication adherence was subsequently discontinued, and medication adherence was not included in the effectiveness analysis.

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

    CVD risk awareness is assessed using the eight knowledge/risk-factor items from the validated Chinese version of the Attitudes and Beliefs about Cardiovascular Disease Risk Questionnaire (ABCD-C). Each item uses a True/False/Don't Know response format and is scored 1 for a correct response and 0 for an incorrect or "Don't Know" response. Item scores are summed to produce a total score ranging from 0 to 8, with higher scores indicating greater CVD risk awareness.

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. 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.

  5. 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.

  6. 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.

Interested in participating?

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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
Sep 10, 2026

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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