← Back to Clinical Trials
Recruiting NCT05827861

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

Trial Parameters

Condition Cardiovascular Diseases
Sponsor National University of Singapore
Study Type INTERVENTIONAL
Phase N/A
Enrollment 1,500
Sex ALL
Min Age 30 Years
Max Age 74 Years
Start Date 2023-05-15
Completion 2025-12
Interventions
HeartAgeHOPE-CVD Mobile AppGenetic Risk Score

Brief 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.

Eligibility 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 f

Related Trials