Evaluating the Impact of HeartAge, Genetic Risk Scores, and HOPE, an Evidence-based Digital Platform for Behaviour Change, on Cardiovascular Disease Risk Factors

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 74
Healthy Volunteers: t
View:

• Aged 30-74 years;

• Singapore citizen, or permanent resident

• Able to read and understand English

• Have access to and is comfortable using an internet-enabled device

• At least 5% risk of CVD, as measured by the Framingham Risk Score (FRS), based on previous health screening results

Locations
Other Locations
Singapore
National University of Singapore
RECRUITING
Singapore
Contact Information
Primary
E Shyong Tai, MD, PhD
mdctes@nus.edu.sg
+65 6516 1048
Backup
Jumana Hashim, MPH
jhashim@nus.edu.sg
+65 6516 4988
Time Frame
Start Date: 2023-05-15
Estimated Completion Date: 2025-12
Participants
Target number of participants: 1500
Treatments
No_intervention: Usual Care
Standard care in which the participant will receive their health screening results using the format used by Health Promotion Board guidelines and a link to a publicly-available website with information on how to manage the risk of heart disease
Experimental: HeartAge only
Participants will be directed to HeartAge, a risk assessment tool available online. Then, they will be directed to a publicly-available website with information on how to manage the risk of heart disease
Experimental: HeartAge and HOPE Platform
Participants will be directed to HeartAge, a risk assessment tool available online. Then, they will be led to download the HOPE-CVD mobile app, an evidence-based behaviour change platform.
Experimental: HeartAge, HOPE Platform, and Genetic Risk Communication
Participants will be directed to HeartAge, a risk assessment tool available online. Then, they will be led to download the HOPE-CVD mobile app, an evidence-based behaviour change platform. Additionally, participants will also receive a report of their genetic risk of CVD.
Related Therapeutic Areas
Sponsors
Leads: National University of Singapore
Collaborators: Singapore General Hospital, Nanyang Technological University, National University Hospital, Singapore, University Health Network, Toronto, National Medical Research Council (NMRC), Singapore

This content was sourced from clinicaltrials.gov