Self-Management assistance for recommended treatment (SMART) IBD app randomized control trial in adolescents with IBD: Design and methodology.

Aims: Adherence to medical regimens, including medications and appointments, is a significant concern for adolescent populations that warrants behavioral interventions. Negative health behaviors during adolescence can persist into adulthood and lead to long-term negative health outcomes. Due to the limited availability and resources for behavioral self-management intervention, many youth do not receive evidence-based behavioral care and continue to struggle with managing their illness. Therefore, there is a need for easily accessible mHealth interventions targeting self-management in order to reduce health care barriers and provide more timely and effective behavioral care particularly during this developmental stage.

Methods: We provide a description of the design and methodology of the Self-Management Assistance for Recommended Treatment (SMART) IBD App randomized controlled pilot trial in pediatric inflammatory bowel disease (IBD) that aims to test the preliminary efficacy of the SMART IBD app compared to a usual care (UC) arm. Thirty participants 13-17 years of age will be recruited and randomized in the trial. Those randomized to the intervention arm will use the app for four weeks, each with one weekly challenge that focuses on self-management. Participants in both arms will complete baseline assessments, daily diaries for four weeks, and post-treatment assessments.

Conclusion: We hypothesize that participants in the intervention arm will experience clinically significant improvements in their self-management compared to those in the UC arm at the post-treatment assessment. Findings from the current study could provide initial evidence to support self-management interventions in adolescents with health conditions via mobile health apps, thereby reducing health care barriers and strains on institutional and nursing resources. Mobile health apps may also be a preferred avenue to disseminate interventions to adolescents.