Actively Recruiting
Healthy Living With Online suPport & Education for Cardiovascular Disease in the Primary Care Setting
Led by Nanyang Technological University · Updated on 2024-05-14
1500
Participants Needed
1
Research Sites
40 weeks
Total Duration
On this page
Sponsors
N
Nanyang Technological University
Lead Sponsor
N
National University of Singapore
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Healthy Living With Online suPport & Education for Cardiovascular Disease in the Primary Care Setting
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 30 to 74 years
- Living in Singapore for the entire 6 months of study participation
- Able to read and understand English
- Have access to and are comfortable using a smartphone
- For patients with diabetes, LDL cholesterol level must be at least 2.6 mmol/L
- For patients without diabetes, LDL cholesterol level must be at least 3.4 mmol/L
You will not qualify if you...
- Diagnosed with heart disease or prior history of angina, cardiac arrhythmia, coronary artery disease, heart failure, myocardial infarction, peripheral vascular disease, revascularisation, stroke, or transient ischaemic attack
- Diagnosed with chronic kidney disease (eGFR <60 ml/min/1.73 m2, or uACR ≥ 3 mg/mmol, or uPCR >15 mg/mmol)
- Have serious mental illness requiring assistance in daily activities
- Pregnant or planning pregnancy in the next six months
- Unable to give informed consent
- Diagnosed with a terminal illness or life expectancy less than 12 months
- Have triglyceride levels ≥ 4.5 mmol/L
- Currently on chemotherapy or completed chemotherapy less than one month ago
- Taking long-term oral steroids
- Currently involved in other HOPE studies (e.g., HOPE-Virtual study)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Lee Kong Chian School of Medicine, NTU
Singapore, Singapore
Actively Recruiting
Research Team
A
Aloysius Chow
CONTACT
M
Mei Li Ng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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