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

NCT05827861 | Completed

• 1 other identifier: 2022-405: HOPE-CVD-Virtual
• Study Type: interventional
• Target: 1,121
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Keywords

Primary Prevention; Digital Health; Genetic risk; lipids; blood pressure; quality of life

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (7)

• Change in Systolic Blood Pressure

  Baseline and Week 24

• Change in Total Cholesterol

  Baseline and Week 24

• Change in High-density lipoprotein cholesterol

  Baseline and Week 24

• Change in Body mass index

  Baseline and Week 24

• Change in smoking habit

  Baseline and Week 24

Study Arms (4)

Usual Care

NO INTERVENTION

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

HeartAge only

EXPERIMENTAL

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

Behavioral: HeartAge

HeartAge and HOPE Platform

EXPERIMENTAL

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.

Behavioral: HeartAge; Behavioral: HOPE-CVD Mobile App

HeartAge, HOPE Platform, and Genetic Risk Communication

EXPERIMENTAL

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.

Behavioral: HeartAge; Behavioral: HOPE-CVD Mobile App; Behavioral: Genetic Risk Score

Interventions

HeartAge BEHAVIORAL

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.

HeartAge and HOPE Platform; HeartAge only; HeartAge, HOPE Platform, and Genetic Risk Communication

HOPE-CVD Mobile App BEHAVIORAL

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.

HeartAge and HOPE Platform; HeartAge, HOPE Platform, and Genetic Risk Communication

Genetic Risk Score BEHAVIORAL

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.

HeartAge, HOPE Platform, and Genetic Risk Communication

Eligibility Criteria

• Age: 30 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Suffering from cancer or chronic kidney disease
• Currently prescribed with statins, exetimibe and pcsk-9 inhibitors to treat cholesterol levels
• Been told by a doctor that they should only do physical activity recommended by a doctor due to a heart condition
• 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.)
• 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
• Pregnant or planning to be pregnant in the next 7 months
• Unable to give informed consent

Sponsors & Collaborators

• National University of Singapore: lead
• National Medical Research Council (NMRC), Singapore: collaborator
• Nanyang Technological University: collaborator
• National University Hospital, Singapore: collaborator
• Singapore General Hospital: collaborator
• University Health Network, Toronto: collaborator

Study Sites (1)

National University of Singapore

Singapore, Singapore, 117549, Singapore

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: April 25, 2023
• Study Start: May 15, 2023
• Primary Completion: October 10, 2025
• Study Completion: October 10, 2025
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

SG (1)