The Effect of a Digital Heart Health App and Lifestyle Intervention for Heart Disease in Primary Care.

Launched by UNIVERSITY OF TORONTO · Apr 4, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating whether a digital heart health app, combined with standard medical care, can help people manage their heart health better than just standard care alone. The study aims to see if using this app can lower cholesterol levels and reduce the chances of major heart-related events, like heart attacks or strokes, over a period of seven years. Participants will be randomly assigned to either use the digital app along with their usual treatment or to continue with their usual treatment alone. They'll be asked to fill out online questionnaires, undergo blood tests, and wear devices to monitor their glucose levels and activity at certain times during the first year.

To be eligible for this study, participants need to be at least 45 years old and taking cholesterol-lowering medication, or be at least 50 years old with diabetes and other risk factors for heart disease. They should also have a family doctor in Ontario and a valid health card. Participants will engage in 16 online sessions during the first year to help them use the app effectively and improve their lifestyle habits. After seven years, everyone will be invited to continue using the app and will keep participating in health assessments every four years. This study is an opportunity for individuals to take a more active role in managing their heart health with the support of technology.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Be taking statin medication with or without other antihyperlipidemic therapy (stable dose for at least 3-months).
• * Fall under either of the 2 categories:
• • 1) Secondary prevention participants: males and females ≥45 years of age with established atherosclerotic cardiovascular disease (ASCVD) defined as at least one of the following: i. Prior myocardial infarction (MI); ii. Acute coronary syndrome (ACS); iii. Stroke/TIA; iv. Coronary revascularization; v. Documented carotid disease (endarterectomy, carotid stenosis ≥50%); vi. Stable angina; vii. Coronary artery disease (CAD) by angiography; viii. Peripheral artery disease (PAD); ix. Abdominal aortic aneurysm (AAA)
• • 2) High-risk primary prevention participants: males and females ≥50 years of age plus type 2 diabetes requiring treatment with medication and at least one additional risk factor: i. Males ≥55 years of age and females ≥65 years of age; ii. Cigarette smoker or stopped smoking within 3 months before Visit 1; iii. Hypertension and on antihypertensive medication for at least 6-months; iv. Chronic kidney disease (CKD); v. Retinopathy, defined as any of the following: non-proliferative retinopathy, pre-proliferative retinopathy, proliferative retinopathy, maculopathy, advanced diabetic eye disease or a history of photocoagulation
• • Be on a stable dose for at least 3-months of all antihyperlipidemic, antihyperglycemic, antihypertensive, and antiobesity therapies.
• • Have a family physician in Ontario and a valid Ontario Health Card.
• • Have regular access to an online portal
• • Be proficient in English.
• Exclusion Criteria:
• • Major disease expected to result in death within 2 years (except cardiovascular disease)
• • Active sever liver disease
• • Malabsorption disorders
• • Drug or alcohol abuse disorders (within past 6 months)
• • Intolerance or allergies to soy protein and tree nuts, peanuts, or seeds
• • Planned coronary intervention or any major surgical procedure
• • Participation in another clinical trial (within past 3 months)
• • End stage renal disease (requirement for peritoneal dialysis or hemodialysis for renal insufficiency or eGFR \<30 mL/min)
• • Any condition or therapy which might pose a risk to the patient or make participation in the study not be in the best interest of the patient as assessed by the investigator
• • Documented severe (New York Heart Association \[NYHA\] class IV) heart failure
• • Mental/psychological impairment expected to affect adherence to the study protocol
• • Known AIDS (HIV-positive patients without AIDS are allowed)
• • Women planning on becoming pregnant within the first year of the intervention
• • Unable to provide informed consent: Appear unable to comprehend the study protocol during the interview process or to understand and communicate in English sufficiently for informed consent.