Clinical trial NCT05827861: HOPE-CVD-Virtual: A Virtual Trial to Evaluate the Primary Prevention of CVD
Official title: Evaluating the Impact of HeartAge, Genetic Risk Scores, and HOPE, an Evidence-based Digital Platform for Behaviour Change, on Cardiovascular Disease Risk Factors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Primary Prevention
Digital Health
Genetic risk
lipids
blood pressure
quality of life
Lead sponsor: National University of Singapore
Sponsor class: OTHER
Collaborators: name: National Medical Research Council (NMRC), Singapore
name: Nanyang Technological University
name: National University Hospital, Singapore
name: Singapore General Hospital
name: University Health Network, Toronto
First posted: 2023-04-25
Enrollment: 1500
Sex: ALL
Minimum age (years): 30
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in 10-yr predicted absolute risk of cardiovascular disease
timeFrame: Baseline and Week 24
measure: Change in Health-Related Quality of Life
timeFrame: Baseline and Week 24
measure: Change in Goal-directed behaviours for living well
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Change in Systolic Blood Pressure
timeFrame: Baseline and Week 24
measure: Change in Total Cholesterol
timeFrame: Baseline and Week 24
measure: Change in High-density lipoprotein cholesterol
timeFrame: Baseline and Week 24
measure: Change in Body mass index
timeFrame: Baseline and Week 24
measure: Change in smoking habit
timeFrame: Baseline and Week 24
measure: Changes in Health-promoting behaviour
timeFrame: Baseline, Week 6 and Week 24
measure: Physical Activity
timeFrame: Week 22
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University of Singapore
Study officials:
References: