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ACTIVE NOT RECRUITING
NCT07123480
NA

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

Sponsor: Baystate Medical Center

View on ClinicalTrials.gov

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.

Official title: The Impact of Informed Consent Type on Participation in an Implementation Science Pilot Study to Improve Cardiac Rehabilitation Participation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2025-07-16

Completion Date

2026-06-30

Last Updated

2025-11-26

Healthy Volunteers

No

Interventions

BEHAVIORAL

Usual Care Group

Standard of care to encourage cardiac rehabilitation attendance.

BEHAVIORAL

More Support and Tools

More Support and Tools includes the following: monetary incentive, text messages, case management, and physical activity coaching. The investigators will start providing support and tools while patients are still in the hospital and continue this support weekly after discharge. Intervention participants will receive a monetary incentive both in the hospital and upon attending cardiac rehabilitation. The support (case management) and tools (physical activity coaching and text messages) will continue for up to 3 months or until the individual attends cardiac rehabilitation, whichever occurs first. Participants can decline any or all support or tools.

Locations (1)

Baystate Medical Center

Springfield, Massachusetts, United States