Cardiovascular Diseases Clinical Trial
Official title:
Evaluating the Impact of HeartAge, Genetic Risk Scores, and HOPE, an Evidence-based Digital Platform for Behaviour Change, on Cardiovascular Disease Risk Factors
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.
Status | Recruiting |
Enrollment | 1500 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 30 Years to 74 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Singapore | National University of Singapore | Singapore |
Lead Sponsor | Collaborator |
---|---|
National University of Singapore | Nanyang Technological University, National Medical Research Council (NMRC), Singapore, National University Hospital, Singapore, Singapore General Hospital, University Health Network, Toronto |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline and Week 24 | |
Primary | 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). | Baseline and Week 24 | |
Primary | 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 | Baseline and Week 24 | |
Secondary | Change in Systolic Blood Pressure | Systolic blood pressure will be measured and compared between the baseline and post-intervention health screenings. | Baseline and Week 24 | |
Secondary | Change in Total Cholesterol | Total cholesterol will be measured and compared between the baseline and post-intervention health screenings. | Baseline and Week 24 | |
Secondary | Change in High-density lipoprotein cholesterol | High-density lipoprotein (HDL) cholesterol will be measured and compared between the baseline and post-intervention health screenings. | Baseline and Week 24 | |
Secondary | 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 | Baseline and Week 24 | |
Secondary | 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 | Baseline and Week 24 | |
Secondary | 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. | Baseline, Week 6 and Week 24 | |
Secondary | 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 | Week 22 |
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