Cardiovascular Diseases (CVD)HOPE-CVD-GPNCT06099353
Healthy Living With Online suPport & Education for Cardiovascular Disease in the Primary Care Setting
A study testing Heart Age, Heart Age-HOPE-CVD App and Communication of Genetic Risk Score in people with Cardiovascular Diseases (CVD), run by Nanyang Technological University at 1 site in Singapore.
Trial summary
This pragmatic four-arm (1:1:1:1) parallel cluster randomised controlled trial (cRCT) aims to evaluate the effectiveness of reducing the risk of cardiovascular disease (CVD) through three combinations of interventions for individuals at risk of CVD in the primary care setting in Singapore. 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 (CVD)
- What is being tested?
- Heart Age, Heart Age-HOPE-CVD App and Communication of Genetic Risk Score
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteSingapore
- Study dates
- 18 Jan 2024to 30 Oct 2024
- 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
- Age 30-74
- Based in Singapore for the duration of study participation (i.e., 6 months)
- Able to read and understand English
- Have access to and is comfortable using a smartphone
- For patients with diabetes, their LDL has to be at least 2.6 mmol/L
- For patients without diabetes, their LDL has to be at least 3.4 mmol/L
Who cannot join
- Have existing heart disease diagnosis or a prior history of any of the following: Angina, Cardiac arrhythmia, Coronary artery disease, Heart failure, Myocardial infarction, Peripheral vascular disease, Revascularisation, Stroke, Transient ischaemic attack
- Patients diagnosed with chronic kidney disease: i.e., eGFR <60ml/min/1.73㎡ OR uACR ≥ 3mg/mmol (30mg/g) OR uPCR >15mg/mmol (150mg/g)
- Patients with serious mental illness (i.e., require assistance in daily activities due to the mental illness)
- Pregnant or planning to be pregnant in the next six months
- Unable to give informed consent
- Diagnosed with a terminal illness or expected life expectancy of less than 12 months
Show all 10Show fewer
- Patients with triglyceride levels of ≥ 4.5 mmol/L
- Patients on chemotherapy course during the study or less than one month prior to participating in the study
- Patients on long-term oral steroids
- Patients who are already involved in other HOPE studies (e.g. HOPE-Virtual study)
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Lee Kong Chian School of Medicine, NTU
Singapore
Eng Sing Lee
About this study
Official title: Effectiveness of Risk Communication Tools and Digital Behaviour Change Platforms to Prevent Cardiovascular Disease in Primary Care: A Cluster Randomised Controlled Trial
This pragmatic four-arm (1:1:1:1) parallel cluster randomised controlled trial (cRCT) aims to evaluate the effectiveness of reducing the risk of cardiovascular disease (CVD) through three combinations of interventions for individuals at risk of CVD in the primary care setting in Singapore. These interventions are a) communicating an individual's phenotypic risk of CVD, b) a digital psychoeducation application (Heart Age-HOPE-CVD app) that supports health-promoting behavioural change, and c) communicating an individual's genetic risk of CVD. Our study hypothesis is that the exposure of these three interventions will have additive effects on the primary and secondary objectives.
The primary objective of our study is to evaluate the impact of each intervention arm compared to usual care (Arm 1) on the risk for CVD, using change in low-density lipoprotein cholesterol (LDL) measurements as the outcome measure. The secondary objective is to evaluate the impact of each intervention arm compared to usual care (Arm 1) on the following: (a) individual CVD risk factors (i.e. blood pressure, total cholesterol, high-density lipoprotein, body mass index, smoking status, fasting blood glucose or glycated haemoglobin, diagnosis of diabetes, triglycerides level), (b) risk for CVD (i.e., estimated using the Framingham Risk Score), (c) health-related quality of life and well-being, and (d) practice of health-promoting behaviours.
The Heart Age-HOPE-CVD app is a 6-month interventional programme. Hence, the effects of the interventions will be evaluated after a 6-month period. Patients will be recruited by general practitioners (GPs) at primary care clinics around Singapore. After obtaining informed consent at baseline, patients' data will be collected at four time points: baseline, mid-intervention at week 6, post-intervention health screening at week 24 and post-intervention at week 26. All data collection will be conducted at the primary care clinic, except for mid-intervention data which will be collected via an online form.
- Conditions
- Cardiovascular Diseases (CVD)
- Being tested
- Heart Age, Heart Age-HOPE-CVD App, Communication of Genetic Risk Score
- Keywords
- Primary prevention, Digital health, Genetic risk, Phenotypic risk, Quality of life, Lipids
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart AgeBehavioural
Heart Age is the phenotypic age based on the risk of the patient participant using a modified tool for CVD risk from the Framingham risk Score. The Heart Age is the age at which an individual would be expected to develop CVD in the next ten years relative to another individual of the same sex and age if all the current CVD risk factors were to be eliminated.
Heart Age-HOPE-CVD AppBehavioural
Patient participants will use an online mobile, evidence-based behavioural change psychoeducation application for 24 weeks. New psychoeducational content is released every week. The first seven weeks of the programme seeks to resolve ambivalence about initiating a lifestyle change and increase the readiness and motivation to change. Between Weeks 8 and 15, the platform will support action planning and guide users to execute their preferred self-care behaviour safely and effectively. The remaining nine weeks will provide the user with the skills that will help them with coping and planning to manage relapses and temptations.
Communication of Genetic Risk ScoreBehavioural
General practitioners will draw 3ml of blood from each patient participant for analysis of the patient's genetic risk score of having cardiovascular disease. This genetic risk score will be communicated to the patient, and the communication will include informing patients what cardiovascular disease genetic risk is, what their genetic risk category compared to the population in Singapore is, and what their score means for the future.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Usual Care | No intervention | * General practitioners' (GPs) usual care for patients. * GPs will direct patient participants to a publicly available webpage about managing CVD risk on the Health Promotion Board website. |
| Arm 2: Heart Age only | Experimental | * General practitioners' (GPs) usual care for patients.
* GPs will direct patient participants to a publicly available webpage about managing CVD risk on the Health Promotion Board website.
* GPs will also show patient participants how to access Heart Age, a risk assessment tool available online and communicate with them their respective Heart Age value. Receives: Behavioral: Heart Age |
| Arm 3: Heart Age and Heart Age-HOPE-CVD app | Experimental | * General practitioners' (GPs) usual care for patients.
* GPs will direct patient participants to a publicly available webpage about managing CVD risk on the Health Promotion Board website.
* GPs will show patient participants how to access Heart Age, a risk assessment tool available online and communicate with them their respective Heart Age value.
* GPs will also direct patient participants to download the Heart Age-HOPE- CVD mobile app, an evidence-based behaviour change digital platform. Receives: Behavioral: Heart Age; Behavioral: Heart Age-HOPE-CVD App |
| Arm 4: Heart Age, HOPE-CVD app, and genetic risk communication | Experimental | * General practitioners' (GPs) usual care for patients.
* GPs will direct patient participants to a publicly available webpage about managing CVD risk on the Health Promotion Board website.
* GPs will show patient participants how to access Heart Age, a risk assessment tool available online and communicate with them their respective Heart Age value.
* GPs will direct patient participants to download the Heart Age-HOPE- CVD mobile app, an evidence-based behaviour change digital platform.
* Patient participants will undergo genetic testing from which a genetic risk score for CVD will be estimated. They will be informed 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. Receives: Behavioral: Heart Age; Behavioral: Heart Age-HOPE-CVD App; Behavioral: Communication of Genetic Risk Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in low density lipoprotein
Low-density lipoprotein cholesterol will be measured and compared between the measurements at baseline and post-intervention health screening.
Measured: Week 0 and Week 24
Secondary outcomes (12)
Change in 10-year predicted absolute risk of cardiovascular disease
Patients' baseline and post-intervention 10-year predicted absolute cardiovascular disease risk will be calculated and compared by a version of the Framingham Risk Score, which is used in the Heart Age algorithm.
The variables (i.e., age, total cholesterol, high-density lipoprotein cholesterol, diabetes prevalence, smoking status, systolic blood pressure, and prescription of anti-hypertensive medications) needed for this algorithm will be measured or obtained at the baseline and post-intervention health screening visits. These variables will be aggregated into a percentage score ranging from 0-100%, where a higher percentage indicates a higher 10-year predicted absolute risk of CVD. A reduction in the percentage score is a better outcome.
Measured: Week 0 and from Week 24
Change in systolic blood pressure
Systolic blood pressure will be measured and compared between the measurements at baseline and post-intervention health screening visits.
Measured: Week 0 and from Week 24
Change in total cholesterol
Total cholesterol will be measured and compared between the measurements at baseline and post-intervention health screening visits.
Measured: Week 0 and from Week 24
Change in high-density lipoprotein cholesterol
High-density lipoprotein cholesterol will be measured and compared between the measurements at baseline and post-intervention health screening visits.
Measured: Week 0 and from Week 24
Change in body mass index
Body mass index (BMI) will be compared between the measurements at baseline and post-intervention health screening visits. BMI will be calculated by dividing weight in kilograms and the square of height in metres (kg/m2).
Measured: Week 0 and from Week 24
Change in smoking habit
Smoking status will be compared between baseline and post-intervention screening visits. The GP will ask the patient participant if she/he is a smoker at the baseline and post-intervention screening visits, and the GP will collect a "Yes" or "No" response.
Measured: Week 0 and from Week 24
Change in fasting blood glucose or glycated haemoglobin measurement
The fasting blood glucose or glycated haemoglobin will be measured and compared between the measurements at baseline and post-intervention health screening visits.
Measured: Week 0 and from Week 24
Change in diagnosis of diabetes
The diagnosis of diabetes will be compared between baseline and post-intervention screening visits. The GP will ask the patient participant if she/he is a smoker at the baseline and post-intervention screening visits, and the GP will collect a "Yes" or "No" response.
Measured: Week 0 and from Week 24
Change in triglycerides
The triglycerides will be measured and compared between the measurements at baseline and post-intervention health screening visits.
Measured: Week 0 and from Week 24
Changes in health-promoting behaviours
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 the Readiness for Change questionnaire using a scale of 1 to 40, where a higher score indicates a better outcome.
Measured: Week 0, Week 6, 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 visits using items in the "EvalUationof goal-diRectedbehaviOurstoPromotewell-beIngandheAlth" scale (Euroia-14). There are 18 items on the Euroia-14 that are separated into four sub-scales (i.e. Self-Affirmation, Social Affiliation, Social Roles and Responsibilities, and Eudemonic). All 18 items are scored between 1 and 4, with a higher score indicating a better outcome.
Measured: Week 0 and from 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 visits using the items from the validated instrument "Short Form 36 version 2" (SF-36v2).
Measured: Week 0 and from Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start18 Jan 2024
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Diseases (CVD)Studies 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
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanyang Technological University
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Singapore, National University Health System, Singapore
- Responsible party
- Principal investigator, Lee Eng Sing, Nanyang Technological University
- Investigators
- Eng Sing Lee, Principal investigator, Nanyang Technological University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099353
- Sponsor's protocol ID
- IRB-2022-928
- Acronym
- HOPE-CVD-GP
- Status last verified
- May 2024
- First submitted
- 18 Oct 2023
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Risk Communication Tools and Digital Behaviour Change Platforms to Prevent Cardiovascular Disease in Primary Care: A Cluster Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06099353
- Acronym / sponsor ID
- HOPE-CVD-GP / IRB-2022-928
- Conditions
- Cardiovascular Diseases (CVD)
- Keywords
- Primary prevention, Digital health, Genetic risk, Phenotypic risk, Quality of life, Lipids
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Nanyang Technological UniversityUniversity, hospital or other
- Collaborators
- National University of Singapore, National University Health System, Singapore
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 25 Oct 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 pragmatic four-arm (1:1:1:1) parallel cluster randomised controlled trial (cRCT) aims to evaluate the effectiveness of reducing the risk of cardiovascular disease (CVD) through three combinations of interventions for individuals at risk of CVD in the primary care setting in Singapore. These interventions are a) communicating an individual's phenotypic risk of CVD, b) a digital psychoeducation application (Heart Age-HOPE-CVD app) that supports health-promoting behavioural change, and c) communicating an individual's genetic risk of CVD. Our study hypothesis is that the exposure of these three interventions will have additive effects on the primary and secondary objectives.
The primary objective of our study is to evaluate the impact of each intervention arm compared to usual care (Arm 1) on the risk for CVD, using change in low-density lipoprotein cholesterol (LDL) measurements as the outcome measure. The secondary objective is to evaluate the impact of each intervention arm compared to usual care (Arm 1) on the following: (a) individual CVD risk factors (i.e. blood pressure, total cholesterol, high-density lipoprotein, body mass index, smoking status, fasting blood glucose or glycated haemoglobin, diagnosis of diabetes, triglycerides level), (b) risk for CVD (i.e., estimated using the Framingham Risk Score), (c) health-related quality of life and well-being, and (d) practice of health-promoting behaviours.
The Heart Age-HOPE-CVD app is a 6-month interventional programme. Hence, the effects of the interventions will be evaluated after a 6-month period. Patients will be recruited by general practitioners (GPs) at primary care clinics around Singapore. After obtaining informed consent at baseline, patients' data will be collected at four time points: baseline, mid-intervention at week 6, post-intervention health screening at week 24 and post-intervention at week 26. All data collection will be conducted at the primary care clinic, except for mid-intervention data which will be collected via an online form.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Usual Care | No intervention | –* General practitioners' (GPs) usual care for patients. * GPs will direct patient participants to a publicly available webpage about managing CVD risk on the Health Promotion Board website. |
| Arm 2: Heart Age only | Experimental | Behavioral: Heart Age* General practitioners' (GPs) usual care for patients. * GPs will direct patient participants to a publicly available webpage about managing CVD risk on the Health Promotion Board website. * GPs will also show patient participants how to access Heart Age, a risk assessment tool available online and communicate with them their respective Heart Age value. |
| Arm 3: Heart Age and Heart Age-HOPE-CVD app | Experimental | Behavioral: Heart Age, Behavioral: Heart Age-HOPE-CVD App* General practitioners' (GPs) usual care for patients. * GPs will direct patient participants to a publicly available webpage about managing CVD risk on the Health Promotion Board website. * GPs will show patient participants how to access Heart Age, a risk assessment tool available online and communicate with them their respective Heart Age value. * GPs will also direct patient participants to download the Heart Age-HOPE- CVD mobile app, an evidence-based behaviour change digital platform. |
| Arm 4: Heart Age, HOPE-CVD app, and genetic risk communication | Experimental | Behavioral: Heart Age, Behavioral: Heart Age-HOPE-CVD App, Behavioral: Communication of Genetic Risk Score* General practitioners' (GPs) usual care for patients. * GPs will direct patient participants to a publicly available webpage about managing CVD risk on the Health Promotion Board website. * GPs will show patient participants how to access Heart Age, a risk assessment tool available online and communicate with them their respective Heart Age value. * GPs will direct patient participants to download the Heart Age-HOPE- CVD mobile app, an evidence-based behaviour change digital platform. * Patient participants will undergo genetic testing from which a genetic risk score for CVD will be estimated. They will be informed 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. |
Who may qualify
- Ages
- 30 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 30-74
- Based in Singapore for the duration of study participation (i.e., 6 months)
- Able to read and understand English
- Have access to and is comfortable using a smartphone
- For patients with diabetes, their LDL has to be at least 2.6 mmol/L
Key exclusion criteria (10 listed)
- Have existing heart disease diagnosis or a prior history of any of the following: Angina, Cardiac arrhythmia, Coronary artery disease, Heart failure, Myocardial infarction, Peripheral vascular disease, Revascularisation, Stroke, Transient ischaemic attack
- Patients diagnosed with chronic kidney disease: i.e., eGFR <60ml/min/1.73㎡ OR uACR ≥ 3mg/mmol (30mg/g) OR uPCR >15mg/mmol (150mg/g)
- Patients with serious mental illness (i.e., require assistance in daily activities due to the mental illness)
- Pregnant or planning to be pregnant in the next six months
- Unable to give informed consent
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 |
|---|---|---|
| Heart AgeHeart Age is the phenotypic age based on the risk of the patient participant using a modified tool for CVD risk from the Framingham risk Score. The Heart Age is the age at which an individual would be expected to develop CVD in the next ten years relative to another individual of the same sex and age if all the current CVD risk factors were to be eliminated. | Behavioural | Arm 2: Heart Age only, Arm 3: Heart Age and Heart Age-HOPE-CVD app, Arm 4: Heart Age, HOPE-CVD app, and genetic risk communication |
| Heart Age-HOPE-CVD AppPatient participants will use an online mobile, evidence-based behavioural change psychoeducation application for 24 weeks. New psychoeducational content is released every week. The first seven weeks of the programme seeks to resolve ambivalence about initiating a lifestyle change and increase the readiness and motivation to change. Between Weeks 8 and 15, the platform will support action planning and guide users to execute their preferred self-care behaviour safely and effectively. The remaining nine weeks will provide the user with the skills that will help them with coping and planning to manage relapses and temptations. | Behavioural | Arm 3: Heart Age and Heart Age-HOPE-CVD app, Arm 4: Heart Age, HOPE-CVD app, and genetic risk communication |
| Communication of Genetic Risk ScoreGeneral practitioners will draw 3ml of blood from each patient participant for analysis of the patient's genetic risk score of having cardiovascular disease. This genetic risk score will be communicated to the patient, and the communication will include informing patients what cardiovascular disease genetic risk is, what their genetic risk category compared to the population in Singapore is, and what their score means for the future. | Behavioural | Arm 4: Heart Age, HOPE-CVD app, and genetic risk communication |
Primary outcome
Change in low density lipoprotein
Time frame: Week 0 and Week 24
Low-density lipoprotein cholesterol will be measured and compared between the measurements at baseline and post-intervention health screening.
12 secondary outcomes
Change in 10-year predicted absolute risk of cardiovascular disease
Time frame: Week 0 and from Week 24
Change in systolic blood pressure
Time frame: Week 0 and from Week 24
Change in total cholesterol
Time frame: Week 0 and from Week 24
Change in high-density lipoprotein cholesterol
Time frame: Week 0 and from Week 24
Change in body mass index
Time frame: Week 0 and from Week 24
Change in smoking habit
Time frame: Week 0 and from Week 24
Change in fasting blood glucose or glycated haemoglobin measurement
Time frame: Week 0 and from Week 24
Change in diagnosis of diabetes
Time frame: Week 0 and from Week 24
Change in triglycerides
Time frame: Week 0 and from Week 24
Changes in health-promoting behaviours
Time frame: Week 0, Week 6, and Week 24
Change in goal-directed behaviours for living well
Time frame: Week 0 and from Week 24
Change in health-related quality of life
Time frame: Week 0 and from Week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: No
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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.
Eng Sing Lee principal investigator
Nanyang Technological University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart Age, Heart Age-HOPE-CVD App and Communication of Genetic Risk Score in people with Cardiovascular Diseases (CVD), run by Nanyang Technological University 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 6 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 14 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aloysius Chow (98263487, HOPE@ntu.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in low density lipoprotein (time frame: Week 0 and Week 24). 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 14 May 2024.