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HypertensionE-CHARMNCT07045363

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

A study testing Cognitive Intervention in people with Hypertension, run by Duke Kunshan University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Hypertension
What is being tested?
Cognitive Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
358 participants
Where
1 siteChina
Study dates
19 Aug 2025to 1 Sep 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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-

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Tinglin Community Health Center

    Suzhou, Jiangsu, 215316

Other trials in China

About this study

Official 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

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.

Read the detailed description

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.

Conditions
Hypertension
Being tested
Cognitive Intervention
Keywords
Heart Age, Health education
Medical subject headings
Hypertension, Health Education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive InterventionBehavioural

    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.

Study groups in NCT07045363
Study groupRoleWhat they receive
Usual Care (Control Group)No interventionParticipants 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)ExperimentalParticipants 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.
Receives: Behavioral: Cognitive Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in cardiovascular disease (CVD) risk awareness

    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.

    Measured: 3 months

Secondary outcomes (6)

  1. Change in physical activity level

    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.

    Measured: 3 months

  2. Change in dietary behavior: fruit intake

    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.

    Measured: 3 months

  3. Change in dietary behavior: table salt use

    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.

    Measured: 3 months

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

    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.

    Measured: 3 months

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

    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.

    Measured: 3 months

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

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

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2025
  2. Study start19 Aug 2025
  3. Primary completion1 Dec 2025
  4. Study completion1 Sep 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
358 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07045363
Sponsor's protocol ID
2025HC064
Acronym
E-CHARM
Status last verified
Aug 2026
First submitted
9 Jun 2025
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD will not be made publicly available due to data protection regulations and privacy concerns under local Chinese health authority guidelines. However, de-identified aggregated data may be shared upon reasonable request for academic research purposes. Requests should be submitted to the corresponding author and will be reviewed by the study steering committee.

Publications

  • Wang G, Huang Y, Li B, Zuo Y, Song W, Li Y, Sun Y, Xue N, Wang Z, Wang T, Hu Z. Effectiveness and implementation 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: Protocol for a randomized controlled trial. Contemp Clin Trials. 2026 Apr;163:108258. doi: 10.1016/j.cct.2026.108258. Epub 2026 Feb 17.

    PubMed 41713746

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Intervention in people with Hypertension, run by Duke Kunshan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in cardiovascular disease (CVD) risk awareness (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07045363, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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