Cardiovascular DiseasesNCT05827861
HOPE-CVD-Virtual: A Virtual Trial to Evaluate the Primary Prevention of CVD
A study testing HeartAge, HOPE-CVD Mobile App and Genetic Risk Score in people with Cardiovascular Diseases, run by National University of Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- HeartAge, HOPE-CVD Mobile App and Genetic Risk Score
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,121 participants
- Where
- 1 siteSingapore
- Study dates
- 15 May 2023to 10 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 17Show fewer
- 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
- Current or previous participants in HOPE Pilot Study, or HOPE-CVD-GP study
- Members of the same household or family of existing enrolled participants
Trial locations and contacts
1 site in 1 country.
Singapore1 site
National University of Singapore
Singapore, Singapore, 117549
About this study
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
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:
Read more
- 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.
Read the 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.
- Conditions
- Cardiovascular Diseases
- Being tested
- HeartAge, HOPE-CVD Mobile App, Genetic Risk Score
- Keywords
- Primary Prevention, Digital Health, Genetic risk, lipids, blood pressure, quality of life
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeartAgeBehavioural
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.
HOPE-CVD Mobile AppBehavioural
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.
Genetic Risk ScoreBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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. Receives: Behavioral: HeartAge; Behavioral: HOPE-CVD Mobile App; Behavioral: Genetic Risk Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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
Measured: Baseline and Week 24
Secondary outcomes (7)
Change in Systolic Blood Pressure
Systolic blood pressure will be measured and compared between the baseline and post-intervention health screenings.
Measured: Baseline and Week 24
Change in Total Cholesterol
Total cholesterol will be measured and compared between the baseline and post-intervention health screenings.
Measured: Baseline and Week 24
Change in High-density lipoprotein cholesterol
High-density lipoprotein (HDL) cholesterol will be measured and compared between the baseline and post-intervention health screenings.
Measured: Baseline and Week 24
Change in Body mass index
Body mass index (BMI) will be measured and compared between the baseline and post-intervention health screenings. BMI will be calculated by combining weight in kilograms and height in meters to report BMI in kg/m^2
Measured: Baseline and Week 24
Change in smoking habit
Smoking status will be measured and compared between baseline and post-intervention follow up through self-reported cigarettes smoke per week
Measured: Baseline and Week 24
Changes in Health-promoting behaviour
Health-promoting behaviours will be measured using self-reported questionnaires at baseline, 6 weeks, and 6 months to observe changes over the course of the study. This will be measured using a Readiness for Change questionnaire using a scale of 1 to 40, where a higher score indicates a better outcome.
Measured: Baseline, Week 6 and Week 24
Physical Activity
Physical activity will be objectively measured using an accelerometer at Week 22. Accelerometer will capture physical activity continuously (day and night, 24 hours/day) for 7 days
Measured: Week 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start15 May 2023
- Primary completion10 Oct 2025
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,121 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore, Nanyang Technological University, National University Hospital, Singapore, Singapore General Hospital, University Health Network, Toronto
- Responsible party
- Principal investigator, Tai E Shyong, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827861
- Sponsor's protocol ID
- 2022-405: HOPE-CVD-Virtual
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2023
- Last updated
- 27 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05827861
- Acronym / sponsor ID
- 2022-405: HOPE-CVD-Virtual
- Conditions
- Cardiovascular Diseases
- Keywords
- Primary Prevention, Digital Health, Genetic risk, lipids, blood pressure, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,121 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore, Nanyang Technological University, National University Hospital, Singapore, Singapore General Hospital, University Health Network, Toronto
- Study start
- 15 May 2023 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: HeartAgeParticipants 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 |
| HeartAge and HOPE Platform | Experimental | Behavioral: HeartAge, Behavioral: HOPE-CVD Mobile AppParticipants 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. |
| HeartAge, HOPE Platform, and Genetic Risk Communication | Experimental | Behavioral: HeartAge, Behavioral: HOPE-CVD Mobile App, Behavioral: Genetic Risk ScoreParticipants 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. |
Who may qualify
- Ages
- 30 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeartAgeHeartAge 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. | Behavioural | HeartAge and HOPE Platform, HeartAge only, HeartAge, HOPE Platform, and Genetic Risk Communication |
| HOPE-CVD Mobile AppThe 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. | Behavioural | HeartAge and HOPE Platform, HeartAge, HOPE Platform, and Genetic Risk Communication |
| Genetic Risk ScoreParticipants 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. | Behavioural | HeartAge, HOPE Platform, and Genetic Risk Communication |
Primary outcome
Change in 10-yr predicted absolute risk of cardiovascular disease
Time frame: Baseline and Week 24
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.
Change in Health-Related Quality of Life
Time frame: Baseline and Week 24
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).
Change in Goal-directed behaviours for living well
Time frame: Baseline and Week 24
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
7 secondary outcomes
Change in Systolic Blood Pressure
Time frame: Baseline and Week 24
Change in Total Cholesterol
Time frame: Baseline and Week 24
Change in High-density lipoprotein cholesterol
Time frame: Baseline and Week 24
Change in Body mass index
Time frame: Baseline and Week 24
Change in smoking habit
Time frame: Baseline and Week 24
Changes in Health-promoting behaviour
Time frame: Baseline, Week 6 and Week 24
Physical Activity
Time frame: Week 22
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HeartAge, HOPE-CVD Mobile App and Genetic Risk Score in people with Cardiovascular Diseases, run by National University of Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 10-yr predicted absolute risk of cardiovascular disease (time frame: Baseline and Week 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.