UnknownNot Applicable

Cardiac Rehabilitation for Cardiovascular Risk Reduction in People With Severe and Persistent Mental Illness

Canada46 participantsStarted 2022-12-14

Plain-language summary

The goal of this prospective, randomized trial is to explore the link between cardiovascular disease and mortality in individuals with severe and persistent mental illness (SPMI). The main question it aims to answer is: Is a primary prevention cardiac rehabilitation intervention feasible and effective at reducing cardiovascular risk in people with a primary psychotic disorder or bipolar disorder?" Participants will undergo a multi-component primary prevention intervention program. Researchers will compare with a control group to see if cardiovascular risk reduction is attained.

Who can participate

Age range

30 Years – 59 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥ 30 to 59 years old * Psychiatric diagnosis of schizophrenia, schizoaffective disorder, or bipolar I disorder * 2 or more cardiac risk behaviors or conditions: smoking, obese, hypertension, diabetes, metabolic syndrome, dyslipidemia, obstructive sleep apnea * 10-year Framingham cardiovascular risk score of ≥ 10% (intermediate risk) * Willing to participate in cardiac rehabilitation program Exclusion Criteria: * Psychiatric instability, as judged by treating psychiatrist * Distance from cardiac rehabilitation centre that would preclude participation * Unsafe to participate in the cardiac rehabilitation intervention, as judged by the cardiology assessment * Pregnant * Known coronary artery disease, cerebrovascular disease, or peripheral vascular disease * Court ordered mandatory or tutor

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Efficacy outcome

Timeframe: 9 months

Trial details

NCT IDNCT05659498

SponsorLady Davis Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05

Contact for this trial

Michael J Goldfarb, MD MSc

5143408222 michael.j.goldfarb@mcgill.ca

View on ClinicalTrials.gov More Mental Illness Persistent trials