The Role of 4 Different Consent Approaches on a Pilot Study to Increase Cardiac Rehabilitation At… (NCT07123480) | Clinical Trial Compass
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The Role of 4 Different Consent Approaches on a Pilot Study to Increase Cardiac Rehabilitation Attendance
United States160 participantsStarted 2025-07-16
Plain-language summary
Cardiac Rehabilitation is a lifestyle and exercise program for patients with heart disease. Cardiac Rehabilitation is strongly recommended in guidelines, but only 30% of eligible patients attend.
New strategies are needed to help more patients attend cardiac rehabilitation. In this study, the investigators will see if using an $50 incentive, case management, text messages, and physical activity coaching combined into a single intervention will help more patients attend cardiac rehabilitation.
In preparation for a larger trial, patients will also be randomly assigned to four different ways of seeking their permission to be in a research study. The investigators will see if these approaches affect how many people participate in the research project.
The two main goals of this study is to understand:
1. If the consent approach type impacts participation rates in the research study
2. If the multi-component intervention (case management, financial incentives, text messages, and physical activity coaching) improves cardiac rehabilitation participation within 3 months.
Who can participate
Age range
18 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:
* Only Baystate Medical Center (Springfield, Massachusetts ) adult patients over age 18 who are admitted to Baystate Medical Center Hospital with a non-surgical qualifying diagnosis for outpatient CR will be included. Common diagnoses include all patients with myocardial infarction, stable angina, percutaneous coronary intervention, transcutaneous aortic/mitral valve replacement, and heart failure.
Exclusion Criteria:
\- Patients with coronary artery bypass graft surgery, heart valve surgery, or other open-heart surgical procedures will be excluded, as these patients are much more likely attend CR, typically around 70%. In addition, patients who are referred to CR programs outside the region, where enrollment cannot be tracked, will be excluded.
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.