Abstract 4368937: Rationale and Design of A Pragmatic Clinical Trial of the WE BEAT Well-Being Education Program in Adolescent Congenital Heart Disease: A Pediatric Heart Network (PHN) Study

Abstract

Background: Adolescents with moderate and severe congenital heart disease (CHD) experience considerable risk of mental health comorbidities. Youth with CHD have 5-7 times greater odds of anxiety or depression than children without CHD. Psychological health is important to cardiac health, but there have been few CHD-specific psychological interventions. This PHN study will evaluate the effectiveness of a resilience and well-being-focused telemedicine intervention in adolescents with CHD and provide one of the largest linkages of self-reported psychosocial data with cardiac clinical outcomes. Research Questions: The WE BEAT CHD Study aims to: 1) evaluate the effectiveness of the 5-week WE BEAT telemedicine intervention compared to usual care on self-reported resiliency and psychosocial outcomes including depression, anxiety, and quality of life, 2) determine associations between psychosocial survey data and cardiac outcomes including composite event score, heart failure, and metabolic health, and 3) establish a biorepository to associate psychosocial data with stress-related biomarkers, including stress cortisol, inflammatory biomarkers, and epigenetic aging. Approach: In this 2-arm, 2-staged stratified randomized, parallel, multi-center pragmatic trial (Figure 1), we seek to recruit 390 English or Spanish speaking 12-17-year-olds with moderately or severely complex CHD across ~15 PHN core and auxiliary sites. The intervention arm will include 300 participants and half will be randomized to complete a booster session. Study design was informed by a successful pilot study, patient/family input, and pragmatic clinical trial design. Five 45-minute intervention sessions and study surveys completed at baseline, 5, 18 and 30 weeks will be done remotely via video conferencing and a study mobile app. Home collection of biospecimen samples will be available. Study duration is estimated to be 5 years. Results: The primary outcome will be change in participant self-reported resiliency as measured by the Connor-Davidson Resilience Scale© from baseline to Week 5, with secondary endpoints of change in resiliency from baseline to Weeks 18 and 30. Conclusion: This study addresses the need for promotive mental-health-focused interventions for adolescents with CHD. The pragmatic trial design intends to bolster successful recruitment and ease of translation to clinical practice. Secondary aims position the trial for mechanistic investigations and future ancillary studies.