390 Participants NeededMy employer runs this trial

Well-Being Education for Heart Defects

(PHN WBC Trial)

Recruiting at 13 trial locations
JE
AC
Overseen ByAlliison Crosby-Thompson, MS
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Carelon Research
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help teens with congenital heart disease (CHD) build resilience and improve their quality of life by testing the WE BEAT Well-Being Education Program, a 5-week online group course. Researchers seek to determine if participants in the program manage stress better than those receiving usual care. Participants will be divided into two groups: one will try the WE BEAT program, and the other will continue with their current care routine. Teens aged 12-17 with moderate to severe CHD who speak English or Spanish are encouraged to join. Participants will complete surveys and provide hair or saliva samples over approximately six months. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance the well-being of teens with CHD.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on a wellbeing program rather than medication changes, so you likely won't need to stop your meds, but it's best to confirm with the trial coordinators.

What prior data suggests that the WE BEAT program is safe for teens with congenital heart disease?

Research has shown that the WE BEAT Well-Being Education Program is safe and manageable for teenagers with congenital heart disease (CHD). An initial study reported no serious side effects or problems linked to the program. Most participants found it helpful and easy to follow.

The program builds resilience and coping skills over five weeks through online group sessions. Since it relies on education and doesn't involve medication or medical procedures, the risks remain very low. It uses proven methods and is safe for young people aged 12 to 17.

Overall, current data suggests that the WE BEAT program is a safe choice for teens with CHD who want to manage stress better and improve their quality of life.12345

Why are researchers excited about this trial?

Researchers are excited about the WE BEAT Well-Being Education Program because it offers a unique telemedicine approach for individuals with heart defects, focusing on improving mental and emotional health alongside physical care. Unlike the standard of care, which typically involves regular medical monitoring and physical interventions, this program provides structured support and education remotely, making it more accessible and convenient for patients. By integrating well-being education into the treatment plan, it aims to enhance overall quality of life, which is a fresh angle compared to traditional treatments.

What evidence suggests that the WE BEAT program is effective for improving resilience in teens with congenital heart disease?

Studies have shown that the WE BEAT Well-Being Education Program can effectively help teens with congenital heart disease (CHD) become more resilient. A pilot study found that participants in this 5-week online program developed better coping skills and improved their ability to recover from difficult situations. In this trial, some participants will receive the WE BEAT telemedicine intervention, which teaches resilience and stress management, crucial for enhancing the quality of life in teens with CHD. Although more research is needed to fully confirm its benefits, early results are promising for boosting mental and emotional well-being in this group.12346

Who Is on the Research Team?

MC

Melissa Cousino, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for teens aged 12-17 who have moderate or severe congenital heart disease, speak English or Spanish, get care at certain heart centers, and can give consent with their parent/guardian.

Inclusion Criteria

* English or Spanish language proficiency
I am between 12 and 17 years old.
* Receives cardiology care at a PHN or PHN auxiliary site
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the WE BEAT program, a 5-week group-based online wellbeing and skill-building program

5 weeks
Online sessions

Booster Session

Intervention arm participants may receive a single-session booster at Week 18

1 session
Online session

Follow-up

Participants are monitored for resilience, quality of life, and other psychosocial outcomes

up to 30 weeks
4 sets of online surveys, 3 hair/saliva samples

What Are the Treatments Tested in This Trial?

Interventions

  • WE BEAT Well-Being Education Program

Trial Overview

The study tests a 5-week online group program called WE BEAT that teaches stress management and resilience skills to teens with heart defects. Participants are randomly assigned to either the program or usual care. Some may also get an extra booster session later on.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Intervention armExperimental Treatment1 Intervention
Group II: Usual CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Carelon Research

Lead Sponsor

Trials
76
Recruited
125,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Citations

Developing the WE BEAT Wellbeing Education Program to ...

The WE BEAT Wellbeing Education Program was developed as one of the first resiliency-focused interventions in pediatric heart disease with an overall objective ...

A Pragmatic Clinical Trial of the WE BEAT Well-Being ...

The WE BEAT Well-Being Education Program was developed for pediatric patients with heart disease. The evidence-based components of the 5-module ...

Abstract 4368937: Rationale and Design of A Pragmatic ...

This PHN study will evaluate the effectiveness of a resilience and well-being-focused telemedicine intervention in adolescents with CHD and ...

A pilot study of the WE BEAT Well-Being Education ...

A pilot study of the WE BEAT Well-Being Education Programme to build resilience in adolescents with heart disease - Volume 35 Issue 1.

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39641160/

A pilot study of the WE BEAT Well-Being Education ...

A pilot study of the WE BEAT Well-Being Education Programme to build resilience in adolescents with heart disease. Cardiol Young. 2025 Jan;35 ...

WE BEAT CHD

The WE BEAT Wellbeing Education Program is a 5-week, group-based online program focused on resilience and coping skills training for 12-17 year olds with CHD.