Adolescent Congenital Heart Disease, Patient-Reported Outcome Measures (PROMs), Pragmatic Trial, Resilience, Psychological, Resiliency-building Intervention, Telemedicine-Based Education
Conditions
Keywords
WE BEAT, Well-Being Education Program, Adolescent CHD, Pragmatic Clinical Trial, Telemedicine
Brief 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. 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.
Interventions
BEHAVIORALTelemedicine-based resiliency-building intervention
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.
Sponsors
Carelon Research
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Connor-Davidson Resilience Scale (CD-RISC) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Connor-Davidson Resilience Scale (CD-RISC) | 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) | 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. |
| NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Scales | from baseline to week 5, baseline to week 18, baseline to week 30 | 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. |
| Kessler-6 (K6) | from baseline to week 5, baseline to week 18, baseline to week 30 | 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. |
| PedsQL, Generic Core and Cardiac Module | from baseline to week 5, baseline to week 18, baseline to week 30 | 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). |
| Life's Essential 8 | from baseline to week 5, baseline to week 18, baseline to week 30 | 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. |
| Multidimensional Scale of Perceived Social Support | from baseline to week 5, baseline to week 18, baseline to week 30 | 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. |
| Self-Perceived Health Status | from baseline to week 5, baseline to week 18, baseline to week 30 | 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). |
| WE BEAT Survey | Intervention Participant Report at Week 5 | 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. |
| Concentration of cortisone (biomarker of stress) | baseline, week 5, and week 30 | Hair cortisone levels will be assayed from hair samples |
| Concentration of C-reactive protein (CRP) (biomarker of inflammation) | baseline, week 5, and week 30 | Concentration of C-reactive protein will be assayed from saliva samples |
| Concentration of TNF-alpha (biomarker of inflammation) | baseline, week 5, and week 30 | Concentration of TNF-alpha will be assayed from saliva samples |
| Concentration of IL-6 (biomarker of inflammation) | baseline, week 5, and week 30 | Concentration of IL-6 will be assayed from saliva samples |
| Concentration of IL-8 (biomarker of inflammation) | baseline, week 5, and week 30 | Concentration of IL-8 will be assayed from saliva samples |
| Biomarkers of aging | baseline, week 5, and week 30 | epigenetic markers of aging (from genome-wide epigenetic profiling) will be assayed from whole blood samples from all participants who opted to provide blood for the study |
Countries
United States
Contacts
CONTACTJessica E Teng, MPH
CONTACTAlliison Crosby-Thompson, MS
PRINCIPAL_INVESTIGATORMelissa Cousino, PhD
University of Michigan
Outcome results
None listed