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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
600
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.
Tinglin Community Health Center
Suzhou, Jiangsu, China
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.
Time frame: 3 months
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.
Time frame: 3 months
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.
Time frame: 3 months
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.
Time frame: 3 months
Change in medication adherence
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.
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Time frame: 3 months
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.
Time frame: 3 months
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.
Time frame: 3 months
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).
Time frame: 3 months