NCT05827861

HOPE-CVD-Virtual: A Virtual Trial to Evaluate the Primary Prevention of CVD

Evaluating the Impact of HeartAge, Genetic Risk Scores, and HOPE, an Evidence-based Digital Platform for Behaviour Change, on Cardiovascular Disease Risk Factors

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,500 (estimated)
• Sponsor: National University of Singapore · Academic / Other
• Sex: All
• Age: 30 Years – 74 Years
• Healthy volunteers: Accepted

Summary

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: * Evaluate the impact of each intervention compared to standard care (arm 1) on the risk for cardiovascular disease, estimated using the Framingham Risk Score * Evaluate the impact of each intervention compared to standard care (arm 1) on health-related quality of life and well-being The secondary objectives are: * Evaluate the impact of each intervention compared to standard care (arm 1) on individual risk factors (Blood pressure, Total cholesterol, HDL cholesterol, BMI, Smoking status) for CVD * Evaluate the impact of each intervention compared to standard care (arm 1) on the practice of health-promoting behaviors 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.

Detailed description

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.

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
BEHAVIORAL	HeartAge	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.
BEHAVIORAL	HOPE-CVD Mobile App	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.
BEHAVIORAL	Genetic Risk Score	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.

Timeline

• Start date: 2023-05-15
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2023-04-25
• Last updated: 2025-05-23

Locations

1 site across 1 country: Singapore