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

NCT07123480 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-11-26

No results posted yet for this study

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.

Conditions

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

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.

Sponsors & Collaborators

  • Baystate Medical Center

    lead OTHER

Principal Investigators

  • Quinn R Pack, MD, MSc · Baystate Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-16
Primary Completion
2026-01-31
Completion
2026-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07123480 on ClinicalTrials.gov