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New treatment option for Patient-Reported Outcome Measures (PROMs)
Official title A Pragmatic Clinical Trial of the WE BEAT Well-Being Education Program in Adolescent Congenital Heart Disease: WE BEAT CHD Study
ClinicalTrials.gov ID: NCT07525843
What this study is testing
- What it's testing
- 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.
- Time commitment: about 6 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 17
You may be able to join if
- 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
You likely can't join if
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- 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
- St Louis, Missouri, United States
- New York, New York, United States
- Cincinnati, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Charleston, South Carolina, United States
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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 and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.