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

Nanyang Technological University

Status: Enrolling

Conditions: Cardiovascular Diseases (CVD)

Treatments: Behavioral: Heart Age-HOPE-CVD App; Behavioral: Communication of Genetic Risk Score; Behavioral: Heart Age

Study type: Interventional

Funder types: Other

Identifiers

NCT06099353

IRB-2022-928

Details and patient eligibility

About

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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 30 to 74 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,500 participants in 4 patient groups

Arm 1: Usual Care

No Intervention group

Description:

* 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 group

Description:

* 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.

Treatment:

Behavioral: Heart Age

Arm 3: Heart Age and Heart Age-HOPE-CVD app

Experimental group

Description:

* 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.

Treatment:

Behavioral: Heart Age-HOPE-CVD App

Behavioral: Heart Age

Arm 4: Heart Age, HOPE-CVD app, and genetic risk communication

Experimental group

Description:

* 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.

Treatment:

Behavioral: Heart Age-HOPE-CVD App

Behavioral: Heart Age

Behavioral: Communication of Genetic Risk Score