Digital heart-health app and lifestyle program for adults with heart disease or high-risk diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized interventional study compares a digital heart-health program plus standard primary care to standard care alone in adults taking statin therapy. Participants use a web- and mobile-based app that provides nutrition and lifestyle guidance alongside routine clinical follow-up. Eligible participants are adults on a stable statin dose with either established atherosclerotic cardiovascular disease or older adults with treated type 2 diabetes and additional risk factors. The study will track changes in cardiovascular risk factors and related health measures over the follow-up period.

Why it matters

Who can join: the full rules

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.

Where it's running

• C. David Naylor Building
  Toronto, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Laura Chiavaroli, PhD
• Email: laura.chiavaroli@utoronto.ca
• Phone: 416-946-0579

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.