WE BEAT: a 5-week online wellbeing program for teens with congenital heart disease
A Pragmatic Clinical Trial of the WE BEAT Well-Being Education Program in Adolescent Congenital Heart Disease: WE BEAT CHD Study
This study tries a 5-week online group wellbeing program to see if it helps teens aged 12–17 with moderate-to-severe congenital heart disease become more resilient and improve quality of life compared with usual care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 390 (estimated) |
| Ages | 12 Years to 17 Years |
| Sex | All |
| Sponsor | Carelon Research Academic / other |
| Locations | 14 sites (Stanford, California and 13 other locations) |
| Trial ID | NCT07525843 on ClinicalTrials.gov |
What this trial studies
Adolescents with moderate-to-severe congenital heart disease are randomized to either a 5-week telemedicine group wellbeing and skill-building program (WE BEAT) or usual care and followed for about six months. The study uses participant-reported outcome measures to track resilience, quality of life, and other psychosocial domains before and after the intervention. Clinical data are also collected to explore links between self-reported wellbeing and medical outcomes. The pragmatic design emphasizes remote delivery and real-world applicability across multiple pediatric cardiology centers.
Who should consider this trial
Good fit: Ideal candidates are 12–17-year-olds with moderate or severe complexity congenital heart disease who speak English or Spanish, receive cardiology care at a participating PHN or PHN auxiliary site, and whose parent/guardian and the teen can provide consent/assent and complete study activities.
Not a fit: Patients unlikely to benefit include those with simple/mild CHD, prior heart transplant, non-structural heart disease, significant cognitive or developmental barriers to participation, recent suicidality/psychosis, or who are medically unable to take part or use telemedicine.
Why it matters
Potential benefit: If successful, the program could boost resilience and quality of life for teens with moderate-to-severe CHD and provide a scalable telehealth support option.
How similar studies have performed: Resilience and wellbeing programs for adolescents have shown benefits in other populations, but telemedicine group programs specifically targeted to moderate-to-severe CHD are less well studied and relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Stanford, California and 13 other locations
- Stanford School of Medicine — Stanford, California, United States (Not_yet_recruiting)
- Children's Hospital Colorado — Aurora, Colorado, United States (Recruiting)
- Emory University School of Medicine — Atlanta, Georgia, United States (Not_yet_recruiting)
- University of Kentucky College of Medicine — Lexington, Kentucky, United States (Not_yet_recruiting)
- Boston Children's Hospital — Boston, Massachusetts, United States (Not_yet_recruiting)
- University of Michigan Health System — Ann Arbor, Michigan, United States (Recruiting)
- Washington University School of Medicine — St Louis, Missouri, United States (Not_yet_recruiting)
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (Not_yet_recruiting)
- Columbia University Irving Medical Center — New York, New York, United States (Not_yet_recruiting)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Not_yet_recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Not_yet_recruiting)
- Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States (Not_yet_recruiting)
- Medical University of South Carolina — Charleston, South Carolina, United States (Not_yet_recruiting)
- Primary Children's Hospital, University of Utah — Salt Lake City, Utah, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Melissa Cousino, PhD — University of Michigan
- Study coordinator: Jessica E Teng, MPH
- Email: jessica.teng@carelon.com
- Phone: 6179723047
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.