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

National University of Singapore · 2023
ClinicalTrials.gov · Datasets · License: Public Domain · 2023
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blood-pressurecardiovascular-diseasesdigital-healthlipidsnaprimary-preventionquality-of-life
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.
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