Healthy Living With Online suPport & Education for Cardiovascular Disease in the Primary Care Setting
Effectiveness of Risk Communication Tools and Digital Behaviour Change Platforms to Prevent Cardiovascular Disease in Primary Care: A Cluster Randomised Controlled Trial
Nanyang Technological University
1,500 participants
Jan 18, 2024
INTERVENTIONAL
Conditions
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. 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.
Eligibility
Inclusion Criteria6
- 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 Criteria10
- 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)
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Interventions
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.
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.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06099353