Image

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

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

Recruiting
12-17 years
All
Phase N/A

Powered by AI

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.

Eligibility

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)

Study details
    Patient-Reported Outcome Measures (PROMs)
    Pragmatic Trial
    Adolescent Congenital Heart Disease
    Resiliency-building Intervention
    Resilience
    Psychological
    Telemedicine-Based Education

NCT07525843

Carelon Research

13 May 2026

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.