An interventional study of HeartAge and HOPE-CVD Mobile App in Cardiovascular Diseases, sponsored by National University of Singapore. Completed at 1 site in Singapore. Open to participants aged 30 Years to 74 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-27.
Sponsored by National University of Singapore · Not applicable, Interventional, and Prevention
This 4-arm (1:1:1:1) single-blind randomized controlled trial. Arm 1 will communicate risk and encourage behavioral change that mirrors the standard pathway for health screening in Singapore. Arm 2 replaces the standard report with Heartage to communicate risk. Arm 3 adds the HOPE-CVD app, a digital platform that incorporates evidence based behavioral change techniques, to Arm 2 . Arm 4 adds a genetic risk score to Arm 3.
The primary objectives of this study are to:
The secondary objectives are:
The HOPE-CVD app is a 6-month interventional program. Hence, the effects of the interventions will be evaluated after a 6-month period. Participants will be required to come to the study site twice for baseline and follow-up health screening. All study interventions and other data collected in time points different from baseline and follow-up will be communicated virtually and delivered to participants without additional in-person interaction. Due to this all-virtual nature of the study, participants who need pharmacological therapy (i.e patients with diabetes) will be excluded as they would require a physician's care as well.
During the first visit, participants will be briefed about the study and informed consent will be obtained. Participants will be randomized to one of the four arms and given further details about the study based on their arm allocation. The pre-intervention questionnaire will be administered, followed by their baseline health screening. Genotyping using a micro-array will be used to estimate a genetic risk score, if participants are randomized into Arm 4.
Eligibility will be re-assessed according to the inclusion/exclusion criteria based on the results of baseline health screening. For those eligible, an email to initiate their study activities will be sent (Week 1). Emails will be tailored according to the arm allocation and intervention exposure. This is outlined in the intervention section below. Those who are exposed to the HOPE-CVD programme will receive an email each week for 24 weeks when the content of a new week is released.
All participants will be asked to complete a short questionnaire online (10 minutes) in Week 6. At around week 22, all participants will be sent an accelerometer to wear for 7 days which will capture objective continuous physical activity.
After 24 weeks, participants will be asked to visit the study site for their final visit. During this visit, the investigators will administer the post-intervention questionnaire, post-intervention health screening, and conduct a debrief of the study. Once the post-intervention health screening results are ready, the encrypted health screening results will be emailed to all participants. Those who did not get to experience HeartAge or participate in the HOPE-CVD programme, but wish to do so, will be given access to the intervention. The genetic risk score will not be available to those in Arms 1-3 due to budget constraints.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 1,121 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
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Exclusion Criteria:
The following groups of individuals will be excluded as most of them would require pharmacological therapy for risk factors based on clinical guidelines in Singapore:
Standard care in which the participant will receive their health screening results using the format used by Health Promotion Board guidelines and a link to a publicly-available website with information on how to manage the risk of heart disease
Participants will be directed to HeartAge, a risk assessment tool available online. Then, they will be directed to a publicly-available website with information on how to manage the risk of heart disease
Behavioral: HeartAge
Participants will be directed to HeartAge, a risk assessment tool available online. Then, they will be led to download the HOPE-CVD mobile app, an evidence-based behaviour change platform.
Behavioral: HeartAge · Behavioral: HOPE-CVD Mobile App
Participants will be directed to HeartAge, a risk assessment tool available online. Then, they will be led to download the HOPE-CVD mobile app, an evidence-based behaviour change platform. Additionally, participants will also receive a report of their genetic risk of CVD.
Behavioral: HeartAge · Behavioral: HOPE-CVD Mobile App · Behavioral: Genetic Risk Score
HeartAge is a phenotypic age-based risk presentation which is a modified tool for CVD risk communication based on the Framingham risk Score. The Heart-Age risk presentation is the age at which an individual of the same sex would be expected to experience the same absolute risk as the individual, had their risk factors been 'normal' based on the clinical guidelines.
The HOPE-CVD mobile app is an evidence-based behaviour change platform that runs for 24 weeks. The programme supports behavioural modification through seven self-care behaviours (active living, exercise, weight management, blood pressure-friendly diet, cholesterol-friendly diet, medication adherence and smoke-free lifestyle). To adopt a digital delivery of Motivational Interviewing and Cognitive Behavioural Therapy, the HOPE-CVD platform incorporates interactive decision aids, dramatic vignettes, expert content, peer videos and behaviour tracking.
Participants will undergo genetic testing from which a genetic risk score for CVD will be estimated. they will receive a genetic risk communication which indicates which quartile of genetic risk they are at in comparison to the rest of the population. The report also contains information on what this risk means for their chances of developing cardiovascular disease in the future.
Change in 10-yr predicted absolute risk of cardiovascular disease
Participants' baseline and post-intervention 10-yr predicted absolute cardiovascular disease risk will be calculated and compared by a version of the Framingham Risk Score, which is used in the HeartAge algorithm. The variables (age, total cholesterol, HDL, diabetes prevalence, smoking status, systolic blood pressure, and prescription of anti-hypertensive medications) needed for this algorithm will be measured during the baseline and post-intervention health screenings. These variables will be aggregated into a percentage score ranging from 0-100%, where a higher percentage indicates a higher 10-yr predicted absolute risk of cardiovascular disease. A reduction in the percentage score is a better outcome.
Time frame: Baseline and Week 24
Change in Health-Related Quality of Life
Health-Related Quality of Life will be assessed and compared between baseline and post-intervention follow-up using the items from the validated instrument Short Form 36 version 2 (SF-36v2).
Time frame: Baseline and Week 24
Change in Goal-directed behaviours for living well
Goal-directed behaviours for living well support a process-based approach to well-being which will be measured and compared between baseline and post-intervention follow-up using items in Euroia-14
Time frame: Baseline and Week 24
Change in Systolic Blood Pressure
Systolic blood pressure will be measured and compared between the baseline and post-intervention health screenings.
Time frame: Baseline and Week 24
Change in Total Cholesterol
Total cholesterol will be measured and compared between the baseline and post-intervention health screenings.
Time frame: Baseline and Week 24
Change in High-density lipoprotein cholesterol
High-density lipoprotein (HDL) cholesterol will be measured and compared between the baseline and post-intervention health screenings.
Time frame: Baseline and Week 24
Change in Body mass index
Body mass index (BMI) will be measured and compared between the baseline and post-intervention health screenings. BMI will be calculated by combining weight in kilograms and height in meters to report BMI in kg/m\^2
Time frame: Baseline and Week 24
Change in smoking habit
Smoking status will be measured and compared between baseline and post-intervention follow up through self-reported cigarettes smoke per week
Time frame: Baseline and Week 24
Changes in Health-promoting behaviour
Health-promoting behaviours will be measured using self-reported questionnaires at baseline, 6 weeks, and 6 months to observe changes over the course of the study. This will be measured using a Readiness for Change questionnaire using a scale of 1 to 40, where a higher score indicates a better outcome.
Time frame: Baseline, Week 6 and Week 24
Physical Activity
Physical activity will be objectively measured using an accelerometer at Week 22. Accelerometer will capture physical activity continuously (day and night, 24 hours/day) for 7 days
Time frame: Week 22
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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