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Recruiting Not applicable NCT07525843

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

No applicable phase (e.g. observational)
Conditions: Patient-Reported Outcome Measures (PROMs) Pragmatic Trial Adolescent Congenital Heart Disease Resiliency-building Intervention Resilience, Psychological Telemedicine-Based Education

Sponsor: Carelon Research

trial.available_in: БГ
Overview
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.
Who can participate
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
Telemedicine-based resiliency-building intervention
BEHAVIORAL
Locations 14
United States (14)
University of Michigan Health System
Ann Arbor , Michigan
Kurt R Schumacher, MD, MS
Emory University School of Medicine
Atlanta , Georgia
NOT_YET_RECRUITING
Lazaros Kochilas, MD, MSCR
Children's Hospital Colorado
Aurora , Colorado
Boston Children's Hospital
Boston , Massachusetts
NOT_YET_RECRUITING
Sarah de Ferranti, MD, MPH
Medical University of South Carolina
Charleston , South Carolina
NOT_YET_RECRUITING
Eric Graham, MD
Cincinnati Children's Hospital Medical Center
Cincinnati , Ohio
NOT_YET_RECRUITING
University of Kentucky College of Medicine
Lexington , Kentucky
NOT_YET_RECRUITING
Icahn School of Medicine at Mount Sinai
New York , New York
NOT_YET_RECRUITING
Brett R Anderson, MD, MBA, MS
Columbia University Irving Medical Center
New York , New York
NOT_YET_RECRUITING
Michael P DiLorenzo, MD, MSCE
Children's Hospital of Philadelphia
Philadelphia , Pennsylvania
NOT_YET_RECRUITING
Andrea L Jones, MD, MSCE
Children's Hospital of Pittsburgh
Pittsburgh , Pennsylvania
NOT_YET_RECRUITING
Bryan Goldstein, MD
Primary Children's Hospital, University of Utah
Salt Lake City , Utah
NOT_YET_RECRUITING
Washington University School of Medicine
St Louis , Missouri
NOT_YET_RECRUITING
Aecha M Ybarra, MD, MS
Stanford School of Medicine
Stanford , California
NOT_YET_RECRUITING
Lauren M Schneider, PsyD
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
12 Years
Maximum age
17 Years
Healthy volunteers
No
Start date
01.04.2026
Completion date
01.06.2029
Registry ID
NCT07525843
Source
clinicaltrials.gov
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