Condition: Patient-Reported Outcome Measures (PROMs) · Pragmatic Trial · Adolescent Congenital Heart Disease · Sponsor: Carelon Research
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.
This description comes directly from the study's public registry record.
Jessica E Teng, MPH · 6179723047 · jessica.teng@carelon.com
Alliison Crosby-Thompson, MS · 6179723285 · allison.crosby-thompson@carelon.com
Always discuss trial participation with your own doctor first.
| 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 | Recruiting |
| University of Kentucky College of Medicine | Lexington, Kentucky, United States | Recruiting |
| Boston Children's Hospital | Boston, Massachusetts, United States | 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 | Recruiting |
| Columbia University Irving Medical Center | New York, New York, United States | Recruiting |
| Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio, United States | Recruiting |
| Children's Hospital of Philadelphia | Philadelphia, Pennsylvania, United States | Recruiting |
| Children's Hospital of Pittsburgh | Pittsburgh, Pennsylvania, United States | Recruiting |
+ 2 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07525843