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NCT07525843NARecruiting

A Pragmatic Clinical Trial of the WE BEAT Well-Being Education Program in Adolescent Congenital Heart Disease: WE BEAT CHD Study

Carelon Research

Start Date

4/20/2026

Completion Date

6/1/2029

Summary

The goal of this pragmatic clinical trial is to learn if the WE BEAT program, a 5-week group-based online wellbeing and skill-building program, can help teens with congenital heart disease (CHD) improve their ability to handle stress. The main question it aims to answer is if participants who receive the WE BEAT program become more resilient (the ability to bounce back from from tough times or recover from something difficult) and have better quality of life compared to participants who receive usual care. The study also aims to learn if there are connections between participant-reported psychosocial data (such as resilience, feelings about one's life and one's physical, mental, and social wellbeing) and clinical outcomes. Eligible participants who are 12-17-year-old will be in the study for about 6 months and be randomized to receive either the WE BEAT program or usual care. Following completion of the primary WE BEAT intervention at Week 5, intervention arm participants will be randomized to a single-session booster session (occurring at Week 18) vs no booster session. The booster session will be provided in a similar format to the WE BEAT program. A review of all modules/skills introduced in the program will be provided. All participants will complete 4 sets of online surveys and give 3 hair/saliva samples at different timepoints. Some participants may volunteer to give optional blood and urine samples.

Eligibility Criteria

Age Range: 12 years to 17 years

Inclusion Criteria: * Age 12-17 years old * CHD of moderate or severe complexity (Class II/III, 2018 AHA/ACC ACHD, Table 4) * English or Spanish language proficiency * Receives cardiology care at a PHN or PHN auxiliary site * Parent or guardian and participant willing to comply with protocol and provide written/electronic informed consent and assent Exclusion Criteria: * CHD of mild or simple complexity (Class I, 2018 AHA/ACC ACHD, Table 4) * Prior heart transplant to treat CHD * Heart disease that is not classified as structural CHD (e.g., connective tissue disease, genetic cardiomyopathy, or acquired heart disease) * Cognitive or developmental conditions that limit program participation and/or ability to complete self-reported measures as determined by a primary cardiology clinician * Suicidality, homicidality, or psychosis in the past 12 months as per medical chart review, clinician report, or eligibility screening * Medically unable to participate (e.g., intubated, unable to respond verbally, active delirium)

Interventions

BEHAVIORAL

Telemedicine-based resiliency-building intervention

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Conditions

Patient-Reported Outcome Measures (PROMs)Pragmatic TrialAdolescent Congenital Heart DiseaseResiliency-building InterventionResilience, PsychologicalTelemedicine-Based Education

Locations

Stanford School of Medicine

Stanford, California 94305

United States

Children's Hospital Colorado

Aurora, Colorado 80045

United States

Emory University School of Medicine

Atlanta, Georgia 30322

United States

University of Kentucky College of Medicine

Lexington, Kentucky 40506

United States

Boston Children's Hospital

Boston, Massachusetts 02114

United States

University of Michigan Health System

Ann Arbor, Michigan 48109

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

Icahn School of Medicine at Mount Sinai

New York, New York 10029

United States

Columbia University Irving Medical Center

New York, New York 10032

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio 45229

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania 19104

United States

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania 15224

United States

Medical University of South Carolina

Charleston, South Carolina 29425

United States

Primary Children's Hospital, University of Utah

Salt Lake City, Utah 84108

United States