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

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.

Conditions

• Cardiovascular Diseases

Interventions

BEHAVIORAL

HeartAge

HeartAge is a phenotypic age-based risk presentation which is a modified tool for CVD risk communication based on the Framingham risk Score. The Heart-Age risk presentation is the age at which an individual of the same sex would be expected to experience the same absolute risk as the individual, had their risk factors been 'normal' based on the clinical guidelines.

BEHAVIORAL

HOPE-CVD Mobile App

The HOPE-CVD mobile app is an evidence-based behaviour change platform that runs for 24 weeks. The programme supports behavioural modification through seven self-care behaviours (active living, exercise, weight management, blood pressure-friendly diet, cholesterol-friendly diet, medication adherence and smoke-free lifestyle). To adopt a digital delivery of Motivational Interviewing and Cognitive Behavioural Therapy, the HOPE-CVD platform incorporates interactive decision aids, dramatic vignettes, expert content, peer videos and behaviour tracking.

BEHAVIORAL

Genetic Risk Score

Participants will undergo genetic testing from which a genetic risk score for CVD will be estimated. they will receive a genetic risk communication which indicates which quartile of genetic risk they are at in comparison to the rest of the population. The report also contains information on what this risk means for their chances of developing cardiovascular disease in the future.

Sponsors & Collaborators

• National Medical Research Council (NMRC), Singapore

  collaborator OTHER_GOV

• Nanyang Technological University

  collaborator OTHER

• National University Hospital, Singapore

  collaborator OTHER

• Singapore General Hospital

  collaborator OTHER

• University Health Network, Toronto

  collaborator OTHER

• National University of Singapore

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

74 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-05-15

Primary Completion

2025-10-10

Completion

2025-10-10

Countries

• Singapore

Study Locations