Improving heart health with online support and education in primary care
Effectiveness of Risk Communication Tools and Digital Behaviour Change Platforms to Prevent Cardiovascular Disease in Primary Care: A Cluster Randomised Controlled Trial
This study is testing whether online support and education can help people at risk for heart disease in Singapore lower their cholesterol and improve their heart health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1500 (estimated) |
| Ages | 30 Years to 74 Years |
| Sex | All |
| Sponsor | Nanyang Technological University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Singapore) |
| Trial ID | NCT06099353 on ClinicalTrials.gov |
What this trial studies
This pragmatic four-arm parallel cluster randomized controlled trial evaluates the effectiveness of three interventions aimed at reducing cardiovascular disease (CVD) risk in individuals at risk within Singapore's primary care setting. The interventions include communicating an individual's phenotypic risk of CVD, utilizing a digital psychoeducation application called Heart Age-HOPE-CVD, and sharing genetic risk information. The study will compare these interventions against usual care, measuring outcomes primarily through changes in low-density lipoprotein cholesterol (LDL) levels. The hypothesis is that these interventions will have additive effects on reducing CVD risk.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 30-74 living in Singapore who are at risk for cardiovascular disease and can engage with digital health tools.
Not a fit: Patients with existing heart disease or serious mental illness, as well as those who are pregnant or terminally ill, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly lower the risk of cardiovascular disease in at-risk individuals through targeted interventions.
How similar studies have performed: Other studies have shown promise in using digital health interventions for cardiovascular risk reduction, suggesting a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 30-74 * Based in Singapore for the duration of study participation (i.e., 6 months) * Able to read and understand English * Have access to and is comfortable using a smartphone * For patients with diabetes, their LDL has to be at least 2.6 mmol/L * For patients without diabetes, their LDL has to be at least 3.4 mmol/L Exclusion Criteria * Have existing heart disease diagnosis or a prior history of any of the following: Angina, Cardiac arrhythmia, Coronary artery disease, Heart failure, Myocardial infarction, Peripheral vascular disease, Revascularisation, Stroke, Transient ischaemic attack * Patients diagnosed with chronic kidney disease: i.e., eGFR \<60ml/min/1.73㎡ OR uACR ≥ 3mg/mmol (30mg/g) OR uPCR \>15mg/mmol (150mg/g) * Patients with serious mental illness (i.e., require assistance in daily activities due to the mental illness) * Pregnant or planning to be pregnant in the next six months * Unable to give informed consent * Diagnosed with a terminal illness or expected life expectancy of less than 12 months * Patients with triglyceride levels of ≥ 4.5 mmol/L * Patients on chemotherapy course during the study or less than one month prior to participating in the study * Patients on long-term oral steroids * Patients who are already involved in other HOPE studies (e.g. HOPE-Virtual study)
Where this trial is running
Singapore
- Lee Kong Chian School of Medicine, NTU — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Eng Sing Lee — Nanyang Technological University
- Study coordinator: Aloysius Chow
- Email: HOPE@ntu.edu.sg
- Phone: 98263487
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.