Consent Approaches for Heart Disease Rehabilitation
(MOST-CR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to discover new methods to encourage more heart disease patients to attend cardiac rehabilitation, a program designed to improve heart health through lifestyle changes and exercise. Researchers will test whether a combination of support tools, such as $50 incentives, case management, text messages, and physical activity coaching (referred to as "More Support and Tools"), can boost participation. Additionally, the trial will explore various methods of obtaining patient consent to determine which approach encourages more people to join the study. Suitable candidates include adult patients from Baystate Medical Center who have experienced heart issues like a heart attack or certain valve replacements, excluding those who have undergone open-heart surgery. As an unphased trial, this study provides patients with an opportunity to contribute to innovative strategies that may enhance participation in cardiac rehabilitation.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Why are researchers excited about this trial?
Researchers are excited about this trial because it explores how different consent approaches can impact heart disease rehabilitation. Unlike traditional lengthy consent forms, this trial tests shorter and simpler options, like a three-page key information consent and a one-page opt-out form, potentially making the process less intimidating and easier for patients to understand. By simplifying consent, researchers hope to enhance patient participation and compliance, leading to better rehabilitation outcomes. This trial could pave the way for more patient-friendly consent processes, ultimately improving access to and effectiveness of heart disease treatments.
Who Is on the Research Team?
Quinn R Pack, MD, MSc
Principal Investigator
Baystate Medical Center
Are You a Good Fit for This Trial?
This trial is for patients with heart conditions like heart failure, post-heart attack, or those who've had certain heart surgeries. It's designed to see if different ways of asking for research consent and a combined intervention can increase attendance at cardiac rehab programs.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Consent Approach Evaluation
Participants are randomized to one of four consent approaches to evaluate their impact on study enrollment and population representativeness
Intervention
Participants receive a multi-component intervention including financial incentives, text messaging, case management, and physical activity coaching to increase cardiac rehabilitation participation
Follow-up
Participants are monitored for cardiac rehabilitation attendance and intervention acceptance
What Are the Treatments Tested in This Trial?
Interventions
- More Support and Tools
Find a Clinic Near You
Who Is Running the Clinical Trial?
Baystate Medical Center
Lead Sponsor