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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Massachusetts
Baystate Medical Center
RECRUITING
Springfield
Contact Information
Primary
Karen L Riska, PhD
karen.riska@baystatehealth.org
14137951515
Backup
Catherine Griswold, MSc, MBA
catherine.griswold@baystatehealth.org
Time Frame
Start Date: 2025-07-16
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 160
Treatments
Other: Long Consent
Standard Consent approach (typically 10-12 pages)
Other: Short Consent
Three page key Information consent
Other: Opt-Out
1 page opt-out consent approach
Other: Non-Consenting
No consent
Sponsors
Leads: Baystate Medical Center

This content was sourced from clinicaltrials.gov