A Pragmatic Clinical Trial of the WE BEAT Well-Being Education Program in Adolescent Conge
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 progra
| Condition(s) | Patient-Reported Outcome Measures (PROMs), Pragmatic Trial, Adolescent Congenital Heart Disease, Resiliency-building Intervention, Resilience, Psychological, Telemedicine-Based Education |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 f |
| 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 * Su |
| Ages | 12 Years to 17 Years |
| Sex | All |
| Lead sponsor | Carelon Research |
| Locations | Stanford, California, United States; Aurora, Colorado, United States; Atlanta, Georgia, United States; Lexington, Kentucky, United States; Boston, Massachusetts, United States; Ann Arbor, Michigan, United States (+8 more sites) |
| Start date | 2026-04 |
| NCT ID | NCT07525843 |
| Official listing | https://clinicaltrials.gov/study/NCT07525843 |