Effectiveness of Risk Communication Tools and Digital Behaviour Change Platforms to Prevent Cardiovascular Disease in Primary Care: A Cluster Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Change in low density lipoprotein
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- 未提供
结局指标
主要结局
Change in low density lipoprotein
时间窗: Week 0 and Week 24
Low-density lipoprotein cholesterol will be measured and compared between the measurements at baseline and post-intervention health screening.
次要结局
- Change in systolic blood pressure(Week 0 and from Week 24)
- Change in total cholesterol(Week 0 and from Week 24)
- Change in body mass index(Week 0 and from Week 24)
- Change in smoking habit(Week 0 and from Week 24)
- Change in health-related quality of life(Week 0 and from Week 24)
- Change in 10-year predicted absolute risk of cardiovascular disease(Week 0 and from Week 24)
- Change in triglycerides(Week 0 and from Week 24)
- Change in high-density lipoprotein cholesterol(Week 0 and from Week 24)
- Change in fasting blood glucose or glycated haemoglobin measurement(Week 0 and from Week 24)
- Change in diagnosis of diabetes(Week 0 and from Week 24)
- Changes in health-promoting behaviours(Week 0, Week 6, and Week 24)
- Change in goal-directed behaviours for living well(Week 0 and from Week 24)
研究者
Lee Eng Sing
Assistant Professor
Nanyang Technological University