A virtual program to prevent cardiovascular diseases
Evaluating the Impact of HeartAge, Genetic Risk Scores, and HOPE, an Evidence-based Digital Platform for Behaviour Change, on Cardiovascular Disease Risk Factors
NA · National University of Singapore · NCT05827861
This study is testing four different ways to help people aged 30-74 prevent heart disease and improve their health over 24 weeks.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1500 (estimated) |
| Ages | 30 Years to 74 Years |
| Sex | All |
| Sponsor | National University of Singapore (other) |
| Locations | 1 site (Singapore) |
| Trial ID | NCT05827861 on ClinicalTrials.gov |
What this trial studies
This is a single-blind randomized controlled trial that evaluates four different interventions aimed at preventing cardiovascular diseases (CVD) in participants aged 30-74. Participants will be randomized into one of four arms: standard health screening, HeartAge risk communication, a digital health app with behavioral change techniques, and a combination of the app with a genetic risk score. The study will assess the impact of these interventions on CVD risk, health-related quality of life, and individual risk factors over a 24-week period. Participants will engage with the interventions through tailored emails and complete health screenings at the beginning and end of the study.
Who should consider this trial
Good fit: Ideal candidates are Singapore citizens or permanent residents aged 30-74 with at least a 5% risk of CVD based on the Framingham Risk Score.
Not a fit: Patients with existing heart disease, cancer, chronic kidney disease, or those currently on specific cholesterol medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly reduce the risk of cardiovascular diseases in at-risk individuals through innovative digital health interventions.
How similar studies have performed: Other studies have shown promise in using digital health interventions for cardiovascular disease prevention, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged 30-74 years; 2. Singapore citizen, or permanent resident 3. Able to read and understand English 4. Have access to and is comfortable using an internet-enabled device 5. At least 5% risk of CVD, as measured by the Framingham Risk Score (FRS), based on previous health screening results Exclusion Criteria: 1. Existing heart disease or a prior history of coronary artery disease/angina/myocardial infarction/revascularisation, transient ischaemic attack/stroke, peripheral vascular disease, heart failure and cardiac arrhythmia 2. Suffering from cancer or chronic kidney disease 3. Currently prescribed with statins, exetimibe and pcsk-9 inhibitors to treat cholesterol levels 4. Been told by a doctor that they should only do physical activity recommended by a doctor due to a heart condition 5. Serious mental illness (Eg. A patient who is suffering from serious mental illness refers to those who need assistance in daily activities due to their mental illness.) 6. 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: * Diagnosed with diabetes * For those with FRS of 5-9%, LDL ≥160mg/dL * For those with FRS of 10-19%, LDL ≥130mg/dL * For those with FRS of ≥20%, LDL ≥100mg/dL * Total cholesterol \>280 mg/dL at the point of screening * Systolic blood pressure \>160 mmHg at the point of screening * Triglycerides ≥4.5 mmol/L 7. Pregnant or planning to be pregnant in the next 7 months 8. Unable to give informed consent 9. Current or previous participants in HOPE Pilot Study, or HOPE-CVD-GP study 10. Members of the same household or family of existing enrolled participants
Where this trial is running
Singapore
- National University of Singapore — Singapore, Singapore (RECRUITING)
Study contacts
- Study coordinator: E Shyong Tai, MD, PhD
- Email: mdctes@nus.edu.sg
- Phone: +65 6516 1048
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cardiovascular Diseases, Primary Prevention, Digital Health, Genetic risk, lipids, blood pressure, quality of life