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

National University of Singapore

Status: Enrolling

Conditions: Cardiovascular Diseases

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05827861

2022-405: HOPE-CVD-Virtual

Details and patient eligibility

About

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.

Full description

During the first visit, participants will be briefed about the study and informed consent will be obtained. Participants will be randomized to one of the four arms and given further details about the study based on their arm allocation. The pre-intervention questionnaire will be administered, followed by their baseline health screening. Genotyping using a micro-array will be used to estimate a genetic risk score, if participants are randomized into Arm 4.

Eligibility will be re-assessed according to the inclusion/exclusion criteria based on the results of baseline health screening. For those eligible, an email to initiate their study activities will be sent (Week 1). Emails will be tailored according to the arm allocation and intervention exposure. This is outlined in the intervention section below. Those who are exposed to the HOPE-CVD programme will receive an email each week for 24 weeks when the content of a new week is released.

All participants will be asked to complete a short questionnaire online (10 minutes) in Week 6. At around week 22, all participants will be sent an accelerometer to wear for 7 days which will capture objective continuous physical activity.

After 24 weeks, participants will be asked to visit the study site for their final visit. During this visit, the investigators will administer the post-intervention questionnaire, post-intervention health screening, and conduct a debrief of the study. Once the post-intervention health screening results are ready, the encrypted health screening results will be emailed to all participants. Those who did not get to experience HeartAge or participate in the HOPE-CVD programme, but wish to do so, will be given access to the intervention. The genetic risk score will not be available to those in Arms 1-3 due to budget constraints.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 30 to 74 years old

Volunteers: Accepts Healthy Volunteers

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 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

7. Pregnant or planning to be pregnant in the next 7 months

8. Unable to give informed consent

9. Current or previous participants in HOPE Pilot Study, or HOPE-CVD-GP study

10. Members of the same household or family of existing enrolled participants

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,500 participants in 4 patient groups

Usual Care

No Intervention group

Description:

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 group

Description:

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

Treatment:

Behavioral: HeartAge

HeartAge and HOPE Platform

Experimental group

Description:

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.

Treatment:

Behavioral: HOPE-CVD Mobile App

Behavioral: HeartAge

HeartAge, HOPE Platform, and Genetic Risk Communication

Experimental group

Description:

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.

Treatment:

Behavioral: Genetic Risk Score

Behavioral: HOPE-CVD Mobile App

Behavioral: HeartAge