RECRUITING

ADAPT Micro-Randomized Trial

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

The goal of this study is to collect quantitative and qualitative data that can be used to optimize the HeartSteps mHealth intervention for physical activity. The current version of the intervention is intended to help patients with heart disease increase and maintain their physical activity long-term. To accomplish this goal, a 3-month pilot micro-randomized trial (MRT) will be conducted with 60 patients who are currently completing or have recently completed phase II cardiac rehabilitation (CR). The core of the study participation is the use of the HeartSteps intervention over the course of 3 months. This includes wearing the Fitbit Charge activity tracker during waking hours and using the HeartSteps intervention to support their efforts to be active. The HeartSteps intervention consists of two sets of intervention components: (1) components intended to improve participants' affective associations with physical activity, including activity suggestions designed to to trigger positive feelings and associate them with being active, and prompts to bring their awareness to intrinsically motivating aspects of being active; and (2) components that target reflective self-regulatory processes, including graphs for self-monitoring, prompts to plan activity, and weekly activity goals. How exactly, and how much, participants will use HeartSteps will not be prescribed since our goal is to understand naturalistic trajectory of engagement with the intervention.

Official Title

ADAPT Micro-Randomized Trial

Quick Facts

Study Start:2025-05-20
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06915220

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. * Must be a patient within the Michigan Medicine clinical system with data available in the electronic health record after January 1, 2020.
  2. * Age \> 18
  3. * Owns and is a daily user of an Android or iPhone smartphone with study supported operating software.
  4. * Understands English to enable informed consent, completion of study-related surveys, and compliance with study notifications.
  5. * Will be completing within 30 days or have completed in the last 30 days the cardiac rehabilitation program at Michigan Medicine based on one of the following indications:
  6. * Coronary artery disease (including acute coronary syndromes and stable angina) following percutaneous coronary intervention (PCI)
  7. * Coronary artery disease following coronary artery bypass surgery (CABG)\]
  8. * Valve repair or replacement (either surgical or percutaneous)
  9. * Coronary artery disease or an acute coronary syndrome not requiring revascularization
  1. * Orthopedic or neurological condition limiting ability to actively engage in moderate intensity physical activity (e.g., brisk walking)
  2. * Greater than mild cognitive impairment
  3. * Wrist too large to wear an activity tracker comfortably. This will be assessed by asking participants "If they have ever had difficulty wearing a watch in the past due to the band being too small."
  4. * Currently receiving palliative care and/or in hospice care
  5. * Severe valvular stenosis or regurgitation
  6. * Unrevascularized left main coronary artery disease (\> 50% obstruction on angiography) or proximal left anterior descending disease (\>70% obstruction on angiography).
  7. * Exercise-induced ventricular tachycardia
  8. * Cardiac arrest within the prior 6 months
  9. * New York Heart Association (NYHA) class III or IV heart failure
  10. * Pulmonary arterial hypertension treated with inhaled or intravenous pulmonary hypertension-specific therapy
  11. * Ejection fraction \<40%
  12. * Determined to be unsafe for participation in this program as assessed by a clinical nurse or investigative team.

Contacts and Locations

Study Contact

Pedja Klasnja, Ph.D. in Information Science
CONTACT
734-763-3581
klasnja@umich.edu

Study Locations (Sites)

University of Michigan
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan

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 Date2025-05-20
Study Completion Date2026-03

Study Record Updates

Study Start Date2025-05-20
Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

  • Cardiac Rehabilitation
  • Physical activity
  • mobile health intervention

Additional Relevant MeSH Terms

  • Cardiovascular Diseases