Evaluation of the SMART IBD App Digital Therapeutic Tool for Pediatric Inflammatory Bowel Disease - Project Summary Poor disease self-management is a significant issue in pediatric IBD, with up to 88% of adolescents demonstrating nonadherence to medication. This is a significant concern given that 1) the risk 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 can be up to 12.5% higher; and 3) the estimated annual cost of nonadherence in US health care overall is $300 billion. We have identified numerous factors that interfere with adolescents’ ability to demonstrate optimal self-management of their illness. Although these barriers are amenable to intervention, many adolescents lack the self-management skills to overcome them on their own, and clinic-based self- management efforts have proven unfeasible on a large scale. Through our intervention research in pediatric IBD, we have developed and demonstrated the efficacy of a multicomponent self-management intervention. However, the proportion of the IBD population that could receive this type of treatment is restricted due to limited access (e.g., lack of available trained clinicians, distance between patient homes and treatment facility). In collaboration with key stakeholders (i.e., patients, parents, and providers), we have addressed these accessibility issues by iteratively developing an IBD-specific Self-Management Assistance for Recommended Treatment (SMART) mHealth application, which can be used by all key users to address patient self- management needs. With funding from the Clare Foundation we have adapted evidence-based content developed via our prior R21 (HD074842) for a mobile app developed for both iOS and Android operating systems. The SMART IBD App prompts patients to complete daily diaries assessing disease activity and functional ability, tracks medications and symptoms, personalizes reminders for medication and appointments, provides graphical feedback and IBD-specific education via static content and animated videos, and includes self-management behavioral health challenges using gamification strategies. It is integrated with our electronic medical record, Epic, so providers can access critical self-management data for treatment planning. In this project, we will test, via a Phase IIb randomized controlled clinical trial, the effect of the SMART IBD App on medication adherence, disease activity, functional disability, and health-related quality of life in adolescents with IBD compared to Attention Control. A total of 70 patients and their parents will be enrolled. This study will have a significant impact on public health by providing greater access to evidence-based self-management support to a large proportion of patients who otherwise would not receive this intervention. Given the health and economic impact of poor self-management in IBD, this study is timely and important, as it has the potential to positively impact IBD adherence and health outcomes and serve as a model for self-management intervention across pediatric populations.
