Healthy Living With Online suPport & Education for Cardiovascular Disease in the Primary Care Setting (HOPE-CVD-GP)

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases (CVD)
• Intervention / Treatment: Behavioral: Communication of Genetic Risk Score; Behavioral: Heart Age; Behavioral: Heart Age-HOPE-CVD App

• Study Type: Interventional
• Enrollment (Estimated): 1500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aloysius Chow; Phone Number: 98263487; Email: HOPE@ntu.edu.sg
• Study Contact Backup: Name: Mei Li Ng; Phone Number: 98263487; Email: HOPE@ntu.edu.sg

Study Locations

• Singapore
  • Singapore, Singapore
    • Recruiting
    • Lee Kong Chian School of Medicine, NTU
    • Contact: Eng Sing Lee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria

• 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
• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Arm 1: Usual Care; 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.
Experimental: Arm 2: Heart Age only; 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.	Behavioral: Heart Age; 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.
Experimental: Arm 3: Heart Age and 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.	Behavioral: Heart Age; 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.; Behavioral: Heart Age-HOPE-CVD App; 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.
Experimental: Arm 4: Heart Age, HOPE-CVD app, and genetic risk communication; 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.	Behavioral: Communication of Genetic Risk Score; 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.; Behavioral: Heart Age; 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.; Behavioral: Heart Age-HOPE-CVD App; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in low density lipoprotein	Low-density lipoprotein cholesterol will be measured and compared between the measurements at baseline and post-intervention health screening.	Week 0 and Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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).	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.	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.	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.	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).	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.	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.	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.	Week 0 and from Week 24

Collaborators and Investigators

• Sponsor: Nanyang Technological University
• Collaborators: National University Health System, Singapore; National University of Singapore
• Investigators: Principal Investigator: Eng Sing Lee, Nanyang Technological University

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2024
• Primary Completion (Estimated): October 30, 2024
• Study Completion (Estimated): October 30, 2024

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: October 24, 2023
• First Posted (Actual): October 25, 2023

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 12, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Quality of life; Lipids; Primary prevention; Genetic risk; Digital health; Phenotypic risk
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: IRB-2022-928

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No