Healthy Living With Online suPport & Education for Cardiovascular Disease in the Primary Care Setting

Nanyang Technological University1,500 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Interventions

Heart AgeBEHAVIORAL

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 AppBEHAVIORAL

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 ScoreBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 74 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Change in low density lipoprotein

Low-density lipoprotein cholesterol will be measured and compared between the measurements at baseline and post-intervention health screening.

Time frame: Week 0 and Week 24

Secondary Outcomes

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.