The Role of 4 Different Consent Approaches on a Pilot Study to Increase Cardiac Rehabilitation Attendance

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.

NCT Number	NCT07123480
Lead Sponsor	Baystate Medical Center
Conditions	Ethics, Cardiac Rehabilitation, Coronary Heart Disease (CHD), Heart Failure, Percutaneous Coronary Intervention (PCI), Aortic Valve Replacement, Myocardial Infarction (MI)
Enrollment	160 participants
Start Date	2025-07-16
Primary Completion	2026-01-31 (estimated)
Study Completion	2026-06-30 (estimated)
Updated on ClinicalTrials.gov	2025-11-26