Embedded Community-based Heart-Age Risk Education Trial in Cinese Primary Healthcare
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cognitive Intervention.
- Who it may be relevant to
- Registry conditions: Hypertension. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Behavioral 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.
Primary outcome measures
- Change in cardiovascular disease (CVD) risk awareness [Time frame: 3 months]
Secondary outcome measures (7)
- Change in physical activity level [Time frame: 3 months]
- Change in dietary behavior: fruit intake [Time frame: 3 months]
- Change in dietary behavior: table salt use [Time frame: 3 months]
- Change in medication adherence [Time frame: 3 months]
- Implementation outcomes 1: Feasibility (intervention group only) [Time frame: 3 months]
- Implementation outcomes 2: Acceptability (intervention group only) [Time frame: 3 months]
- Implementation outcomes 3: Fidelity (intervention group only) [Time frame: 3 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
China · 1 center
- Tinglin Community Health Center — Suzhou
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.2026.108 PMID 41713746
Identifiers
NCT: NCT07045363 · 2025HC064