RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-07-16
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07123480

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Karen L Riska, PhD
CONTACT
14137951515
karen.riska@baystatehealth.org
Catherine Griswold, MSc, MBA
CONTACT
catherine.griswold@baystatehealth.org

Principal Investigator

Quinn R Pack, MD, MSc
PRINCIPAL_INVESTIGATOR
Baystate Medical Center

Study Locations (Sites)

Baystate Medical Center
Springfield, Massachusetts, 01199
United States

Collaborators and Investigators

Sponsor: Baystate Medical Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-16
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2025-07-16
Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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