Research on medication adherence in pediatric inflammatory bowel disease (IBD) has demonstrated nonadherence rates ranging from 50-88 percent across medications. These data are alarming given that 1) the risk of relapse in IBD is 5.5 times greater in nonadherent patients than in adherent patients, 2) the annual costs of health care in nonadherent IBD patients are 12.5 percent higher, and 3) the estimated annual cost of nonadherence in US health care is $100-300 billion. Factors related to poor adherence include deficits in knowledge about IBD and medications used for treatment, organizational barriers, and behavioral problems in adolescents and/or their families. Thus, nonadherence is a complex and significant health care issue in IBD, requiring effective multicomponent behavioral intervention to improve treatment outcomes. Our current treatment outcome studies demonstrate the feasibility and preliminary efficacy of family based behavioral intervention for nonadherence. This intervention is viewed favorably by patients and families, and retention is high. Individually-tailored behavioral treatments are advantageous because of their ability to analyze and target specific behaviors that functionally maintain nonadherence, which vary across patients. However, only a limited subgroup of patients is able to receive this type of treatment due to a lack of available trained providers and/or distance between patient homes and their treatment facility, making it prohibitive to attend the necessary weekly treatment sessions. Telehealth delivery of behavioral intervention has been used successfully in pediatric populations, but has not targeted treatment adherence promotion. Determining the most optimal method of treatment delivery to the most patients who would benefit from it is a critical next step in this line of research. Thus, the proposed study aims to test, via a randomized controlled clinical trial, the efficacy of a novel telehealth behavioral treatment (TBT) protocol to improve medication adherence, disease severity, health-related quality of life, and health care utilization in children and adolescents with IBD. Participants in the TBT condition will be compared to those in an education only (EO) condition. In addition to using a novel telehealth approach to delivery of an individually-tailored behavioral treatment for nonadherence in underserved IBD patients, this study will target a clinically relevant sample of patients who demonstrate substantial nonadherence that might affect health outcomes. The proposed study may have a significant impact on public health by providing an evidence base for individually-tailored behavioral treatment of nonadherence delivered in a manner that reduces health care disparities for families that have limited access to services. One hundred ninety-four patients (11-18 years of age) and their parents will be enrolled in the study. Given the prevalence of nonadherence in IBD and its health and economic impact, this study is timely and important, as it has the potential to optimize behavioral treatment of nonadherence, positively impact IBD health outcomes, and serve as a model for adherence intervention in other pediatric populations.

National Institute of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Research Project (R01)
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Behavioral Medicine, Interventions and Outcomes Study Section (BMIO)
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Lee, Karen
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Cincinnati Children's Hospital Medical Center
United States
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