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

NCT07123480 | Active Not Recruiting

• 1 other identifier: 2311694
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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. 1.If the consent approach type impacts participation rates in the research study
2. 2.If the multi-component intervention (case management, financial incentives, text messages, and physical activity coaching) improves cardiac rehabilitation participation within 3 months.

Conditions

Ethics; Cardiac Rehabilitation; Coronary Heart Disease (CHD); Heart Failure; Percutaneous Coronary Intervention (PCI); Aortic Valve Replacement; Myocardial Infarction (MI)

Keywords

Cardiac Rehabilitation; Informed Consent Approach; Phase 2; implementation science

Outcome Measures

Primary Outcomes (1)

• Informed Consent Approach Participation

  The proportion of patients (%) participating in the clinical trial.

  Baseline

Secondary Outcomes (7)

• Cardiac Rehabilitation Attendance

  Up to to 3 months after hospital discharge, or cardiac rehabilitation attendance, whichever comes first.

• Age Representativeness of Consenting Groups

  Baseline

• Sex Representativeness of Consenting Groups

  Baseline

• Race Representativeness of Consenting Groups

  Baseline

• Ethnicity Representativeness of Consenting Groups

  Baseline

Study Arms (4)

Long Consent

OTHER

Standard Consent approach (typically 10-12 pages)

Behavioral: Usual Care Group; Behavioral: More Support and Tools

Short Consent

OTHER

Three page key Information consent

Behavioral: Usual Care Group; Behavioral: More Support and Tools

Opt-Out

OTHER

1 page opt-out consent approach

Behavioral: Usual Care Group; Behavioral: More Support and Tools

Non-Consenting

OTHER

No consent

Behavioral: Usual Care Group; Behavioral: More Support and Tools

Interventions

Usual Care Group BEHAVIORAL

Standard of care to encourage cardiac rehabilitation attendance.

Long Consent; Non-Consenting; Opt-Out; Short Consent

More Support and Tools BEHAVIORAL

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.

Long Consent; Non-Consenting; Opt-Out; Short Consent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Baystate Medical Center: lead

Study Sites (1)

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

MeSH Terms

Conditions

Coronary Disease; Heart Failure; Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Quinn R Pack, MD, MSc

  Baystate Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director of Cardiac Rehabilitation and Wellness

Model Details: An open-label prospective double randomized control study at Baystate Medical Center, a 760-bed academic teaching hospital. Patients are first randomized to one of the four consent approaches. If the patients agree to participate or are in the non-consent group, the patients will be re-randomized 1:1 to either Usual Care or the More Support and Tools Program (MOST).

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 14, 2025
• Study Start: July 16, 2025
• Primary Completion: January 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

US (1)