Patient-Reported Outcome Measures (PROMs)PHN WBCNCT07525843
A Pragmatic Clinical Trial of the WE BEAT Well-Being Education Program in Adolescent Congenital Heart Disease: WE BEAT CHD Study
A study testing Telemedicine-based resiliency-building intervention in people with Patient-Reported Outcome Measures (PROMs) and Pragmatic Trial, run by Carelon Research at 14 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Patient-Reported Outcome Measures (PROMs), Pragmatic Trial, Adolescent Congenital Heart Disease
- What is being tested?
- Telemedicine-based resiliency-building intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 14 sitesUnited States
- Study dates
- 20 Apr 2026to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
United States14 sites, 14 recruiting
- Recruiting
University of Michigan Health System
Ann Arbor, Michigan, 48109
Adriana Batazzi, 732-615-2369, batazzia@med.umich.edu
Kurt Schumacher, MD, MS
- Recruiting
Emory University School of Medicine
Atlanta, Georgia, 30329
Lead Study Coordinator, 404-785-7453, Madison.Chapman@choa.org
Lazaros Kochilas, MD, MSCR
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
Lead Study Coordinator, 720-777-8306, Amy.Fung@childrenscolorado.org
Sarah Kelly, PsyD
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02114
Zoe Wernsing, 617-355-4266, Zoe.wernsing@childrens.harvard.edu
Thomas Giorgio, 617-355-4201, Thomas.giorgio@cardio.chboston.org
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Lead Study Coordinator, 843-494-3796, headleyt@musc.edu
Eric Graham, MD
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Lead Study Coordinator, 513-803-3350, Elise.Pickering@cchmc.org
Paul Critser, MD, PhD
- Recruiting
University of Kentucky College of Medicine
Lexington, Kentucky, 40506
Heather Collins, 859-562-1103, heather.collins1@uky.edu
Louis I Bezold, MD
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Lead Study Coordinator, 509-919-0238, anna.wirthlin@mssm.edu
Brett Anderson, MD, MBA, MS
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Lead Study Coordinator, 212-342-3785, nb3384@cumc.columbia.edu
Michael DiLorenzo, MD, MSCE
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Lead Study Coordinator, 267-426-9271, HAYDENC@chop.edu
Andrea Jones, MD, MSCE
- Recruiting
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Lead Study Coordinator, 412-692-6762, melissa.evans@chp.edu
Bryan Goldstein, MD
- Recruiting
Primary Children's Hospital, University of Utah
Salt Lake City, Utah, 84108
Laura Wood, PhD, 713-557-4868, laura.k.wood@hsc.utah.edu
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Lead Study Coordinator, 314-273-5642, ayalaa@wustl.edu
Aecha Ybarra, MD, MS
- Recruiting
Stanford School of Medicine
Stanford, California, 94305
Lead Study Coordinator, 650-498-8585, sanamann@stanford.edu
Lauren Schneider, PsyD
About this study
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 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 urine and second saliva samples.
- Conditions
- Patient-Reported Outcome Measures (PROMs), Pragmatic Trial, Adolescent Congenital Heart Disease, Resiliency-building Intervention, Resilience, Psychological, Telemedicine-Based Education
- Being tested
- Telemedicine-based resiliency-building intervention
- Keywords
- WE BEAT, Well-Being Education Program, Adolescent CHD, Pragmatic Clinical Trial, Telemedicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine-based resiliency-building interventionBehavioural
Improving Access and Increasing Resilience through the WE BEAT Well-Being Education Program. The WE BEAT Well-Being Education Program was developed for pediatric patients with heart disease. The evidence-based components of the 5-module WE BEAT intervention are derived from cognitive behavioral theory, stress management and resiliency research, and behavioral intervention science across pediatric populations and adult heart disease. The five WE BEAT modules include: Well-being Education--Introduction, Breathe--Mindfulness and Relaxation-Based Skills, Energize--Positive Psychology Skills, Adjust--Cognitive Skills Training, and Thanks--Gratitude Practice. The objective is to foster positive psychological well-being and resilient outcomes in adolescents with CHD through a mental health promotion and prevention while providing access to safe, peer-to-peer community building. Through its group-based telemedicine delivery, the program aims to increase access to mental health care.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Usual Care arm used as a control |
| Intervention arm | Experimental | WE BEAT telemedicine intervention Receives: Behavioral: Telemedicine-based resiliency-building intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Connor-Davidson Resilience Scale (CD-RISC)
Connor-Davidson Resilience Scale© (CD-RISC©) is a self-reported, unidimensional 5-point Likert scale measuring resilience. Total scores range from 0-40 with higher scores indicating greater resilience. It has been validated for use in children and adolescents across various countries.
Measured: from baseline to week 5 (immediately post-intervention).
Secondary outcomes (14)
Connor-Davidson Resilience Scale (CD-RISC)
Connor-Davidson Resilience Scale© (CD-RISC©) is a self-reported, unidimensional 5-point Likert scale measuring resilience. Total scores range from 0-40 with higher scores indicating greater resilience. It has been validated for use in children and adolescents across various countries.
Measured: from baseline to Week 18, from baseline to week 30, from baseline to week 5 (for the subpopulation of participants with moderate to low baseline CD-RISC)
NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Scales
NIH Patient-Reported Outcomes Measurement Information System® (PROMIS®) Scales is a self-reported, 5-point Likert scales measuring depressive symptoms (8 items); anxiety (8 items); meaning and purpose in life (4 items); life satisfaction (4 items).The NIH PROMIS® Scales have been validated for use in children with chronic health conditions ages 8-17 years old.
Measured: from baseline to week 5, baseline to week 18, baseline to week 30
Kessler-6 (K6)
Kessler-6 (K6) is a self-reported, 5-point Likert scale measuring general distress. Total scores range from 0-24 with higher scores indicating more psychological distress.
Measured: from baseline to week 5, baseline to week 18, baseline to week 30
PedsQL, Generic Core and Cardiac Module
PedsQL, Generic Core and Cardiac Module is a self-reported; 5-point Likert scale measuring health-related quality of life (HRQOL). Scores will be transformed to a 0-100 scale with higher scores indicating more positive HRQOL. The PedsQL™ Generic Core is widely used and includes four domains: Physical, Emotional, Social, and School functioning. The PedsQL™ Cardiac Module is administered in addition to the PedsQL™ Generic Core to gather cardiac-specific constructs important to QOL. Subscales include: Heart Problems and Treatment (e.g., symptoms, medical interventions), Treatment Barriers (e.g., difficulty accessing care, adherence with treatment), Perceived Physical Appearance (e.g., concerns related to scars, body image), Treatment Anxiety (e.g., worries about medical procedures and hospital visits), Cognitive Problems (e.g., difficulties in concentrating, memory issues), and Communication (e.g., ability to discuss condition and treatment with others).
Measured: from baseline to week 5, baseline to week 18, baseline to week 30
Life's Essential 8
Life's Essential 8 is a self-reported scoring tool measuring lifestyle behaviors. Items include assessment of diet, sleep, physical activity, and nicotine use/exposure.
Measured: from baseline to week 5, baseline to week 18, baseline to week 30
Multidimensional Scale of Perceived Social Support
Multidimensional Scale of Perceived Social Support is a self-reported; 7-point Likert scale measuring perceived social support. Total score ranges from 1-7 with higher scores indicating more perceived social support. Subscales include: family subscale, friends subscale, and significant other subscale.
Measured: from baseline to week 5, baseline to week 18, baseline to week 30
Self-Perceived Health Status
Self-Perceived Health Status is a self-reported; linear analog scale. Subjectively perceived health status will be measured with a linear analogue scale ranging from the ''worst imaginable health state'' (score of 0) to the ''best imaginable health state'' (score of 100).
Measured: from baseline to week 5, baseline to week 18, baseline to week 30
WE BEAT Survey
WE BEAT Survey is a self-reported. An investigator-designed survey used to gather WE BEAT session and overall program ratings and acceptability, as well as feedback and ideas for program improvement.
Measured: Intervention Participant Report at Week 5
Concentration of cortisone (biomarker of stress)
Hair cortisone levels will be assayed from hair samples
Measured: baseline, week 5, and week 30
Concentration of C-reactive protein (CRP) (biomarker of inflammation)
Concentration of C-reactive protein will be assayed from saliva samples
Measured: baseline, week 5, and week 30
Concentration of TNF-alpha (biomarker of inflammation)
Concentration of TNF-alpha will be assayed from saliva samples
Measured: baseline, week 5, and week 30
Concentration of IL-6 (biomarker of inflammation)
Concentration of IL-6 will be assayed from saliva samples
Measured: baseline, week 5, and week 30
Concentration of IL-8 (biomarker of inflammation)
Concentration of IL-8 will be assayed from saliva samples
Measured: baseline, week 5, and week 30
Biomarkers of aging
epigenetic markers of aging (from genome-wide epigenetic profiling) will be assayed from saliva samples from all participants who opted to provide optional saliva for the study
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start20 Apr 2026
- Primary completionApr 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient-Reported Outcome Measures (PROMs)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible participants will be randomly assigned to one of two treatment arms: intervention or usual care. Participants will be randomized in an approximately 3:1 ratio (3 in the intervention arm to 1 in the usual care arm) and in the order they are enrolled into the study. 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. Intervention arm participants who missed more than 2 program sessions will not be eligible for the booster.
- Masking
- None (open label)
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carelon Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Melissa Cousino, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07525843
- Sponsor's protocol ID
- 20858 PHN WBC
- Other IDs
- U24HL172722
- Acronym
- PHN WBC
- Status last verified
- Apr 2026
- First submitted
- 23 Mar 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: PUD (Public Use Datasets) are planned to be created at the end of the study
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- PHN WBC / 20858 PHN WBC
- Conditions
- Patient-Reported Outcome Measures (PROMs), Pragmatic Trial, Adolescent Congenital Heart Disease, Resiliency-building Intervention, Resilience, Psychological, Telemedicine-Based Education
- Keywords
- WE BEAT, Well-Being Education Program, Adolescent CHD, Pragmatic Clinical Trial, Telemedicine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- Carelon ResearchUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 urine and second saliva samples.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible participants will be randomly assigned to one of two treatment arms: intervention or usual care. Participants will be randomized in an approximately 3:1 ratio (3 in the intervention arm to 1 in the usual care arm) and in the order they are enrolled into the study. 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. Intervention arm participants who missed more than 2 program sessions will not be eligible for the booster.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Usual Care arm used as a control |
| Intervention arm | Experimental | Behavioral: Telemedicine-based resiliency-building interventionWE BEAT telemedicine intervention |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemedicine-based resiliency-building interventionImproving Access and Increasing Resilience through the WE BEAT Well-Being Education Program. The WE BEAT Well-Being Education Program was developed for pediatric patients with heart disease. The evidence-based components of the 5-module WE BEAT intervention are derived from cognitive behavioral theory, stress management and resiliency research, and behavioral intervention science across pediatric populations and adult heart disease. The five WE BEAT modules include: Well-being Education--Introduction, Breathe--Mindfulness and Relaxation-Based Skills, Energize--Positive Psychology Skills, Adjust--Cognitive Skills Training, and Thanks--Gratitude Practice. The objective is to foster positive psychological well-being and resilient outcomes in adolescents with CHD through a mental health promotion and prevention while providing access to safe, peer-to-peer community building. Through its group-based telemedicine delivery, the program aims to increase access to mental health care. | Behavioural | Intervention arm |
Primary outcome
Connor-Davidson Resilience Scale (CD-RISC)
Time frame: from baseline to week 5 (immediately post-intervention).
Connor-Davidson Resilience Scale© (CD-RISC©) is a self-reported, unidimensional 5-point Likert scale measuring resilience. Total scores range from 0-40 with higher scores indicating greater resilience. It has been validated for use in children and adolescents across various countries.
14 secondary outcomes
Connor-Davidson Resilience Scale (CD-RISC)
Time frame: from baseline to Week 18, from baseline to week 30, from baseline to week 5 (for the subpopulation of participants with moderate to low baseline CD-RISC)
NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Scales
Time frame: from baseline to week 5, baseline to week 18, baseline to week 30
Kessler-6 (K6)
Time frame: from baseline to week 5, baseline to week 18, baseline to week 30
PedsQL, Generic Core and Cardiac Module
Time frame: from baseline to week 5, baseline to week 18, baseline to week 30
Life's Essential 8
Time frame: from baseline to week 5, baseline to week 18, baseline to week 30
Multidimensional Scale of Perceived Social Support
Time frame: from baseline to week 5, baseline to week 18, baseline to week 30
Self-Perceived Health Status
Time frame: from baseline to week 5, baseline to week 18, baseline to week 30
WE BEAT Survey
Time frame: Intervention Participant Report at Week 5
Concentration of cortisone (biomarker of stress)
Time frame: baseline, week 5, and week 30
Concentration of C-reactive protein (CRP) (biomarker of inflammation)
Time frame: baseline, week 5, and week 30
Concentration of TNF-alpha (biomarker of inflammation)
Time frame: baseline, week 5, and week 30
Concentration of IL-6 (biomarker of inflammation)
Time frame: baseline, week 5, and week 30
Concentration of IL-8 (biomarker of inflammation)
Time frame: baseline, week 5, and week 30
Biomarkers of aging
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Yes. PUD (Public Use Datasets) are planned to be created at the end of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melissa Cousino, PhD principal investigator
University of Michigan
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine-based resiliency-building intervention in people with Patient-Reported Outcome Measures (PROMs) and Pragmatic Trial, run by Carelon Research at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica E Teng, MPH (6179723047, jessica.teng@carelon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Connor-Davidson Resilience Scale (CD-RISC) (time frame: from baseline to week 5 (immediately post-intervention).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.