Clinical trial NCT06099353: Healthy Living With Online suPport & Education for Cardiovascular Disease in the Primary Care Setting
Official title: Effectiveness of Risk Communication Tools and Digital Behaviour Change Platforms to Prevent Cardiovascular Disease in Primary Care: A Cluster Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases (CVD)
Keywords: Primary prevention
Digital health
Genetic risk
Phenotypic risk
Quality of life
Lipids
Lead sponsor: Nanyang Technological University
Sponsor class: OTHER
Collaborators: name: National University of Singapore
name: National University Health System, Singapore
First posted: 2023-10-25
Enrollment: 1500
Sex: ALL
Minimum age (years): 30
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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)

Primary outcomes:
measure: Change in low density lipoprotein
timeFrame: Week 0 and Week 24
Secondary outcomes:
measure: Change in 10-year predicted absolute risk of cardiovascular disease
timeFrame: Week 0 and from Week 24
measure: Change in systolic blood pressure
timeFrame: Week 0 and from Week 24
measure: Change in total cholesterol
timeFrame: Week 0 and from Week 24
measure: Change in high-density lipoprotein cholesterol
timeFrame: Week 0 and from Week 24
measure: Change in body mass index
timeFrame: Week 0 and from Week 24
measure: Change in smoking habit
timeFrame: Week 0 and from Week 24
measure: Change in fasting blood glucose or glycated haemoglobin measurement
timeFrame: Week 0 and from Week 24
measure: Change in diagnosis of diabetes
timeFrame: Week 0 and from Week 24
measure: Change in triglycerides
timeFrame: Week 0 and from Week 24
measure: Changes in health-promoting behaviours
timeFrame: Week 0, Week 6, and Week 24
measure: Change in goal-directed behaviours for living well
timeFrame: Week 0 and from Week 24
measure: Change in health-related quality of life
timeFrame: Week 0 and from Week 24
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Lee Kong Chian School of Medicine, NTU
Study officials:
affiliation: Nanyang Technological University
name: Eng Sing Lee
role: PRINCIPAL_INVESTIGATOR
References: