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

ConditionHypertension
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorDuke Kunshan University

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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-

Disqualifiers

Diagnosed dementia or severe cognitive impairment

Terminal illness

Participation in another clinical intervention trial

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: Usual Care (Control Group)No intervention 0 interventions
Group B: Heart Age Communication (Intervention Group)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
3 months
4

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.

Time frame
3 months

Other outcomes

1

Change in systolic blood pressure

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

Time frame
12 months
2

Change in diastolic blood pressure

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

Time frame
12 months
3

Change in body mass index (BMI)

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

Time frame
12 months
4

Change in fasting plasma glucose

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

Time frame
12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke Kunshan University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: