PROJECT SUMMARY/ABSTRACT Candidate: Shirley Cohen-Mekelburg, M.D., M.S. is a gastroenterologist with master’s level clinical research training. Her long-term career goal is to become an independent clinical investigator and to develop and evaluate self-management interventions to improve health outcomes for patients with inflammatory bowel disease (IBD). This K23 will provide Dr. Cohen-Mekelburg with the training and support to achieve her career goals and improve IBD care and outcomes by assisting patients in IBD self-management. Research context: The management of active IBD (i.e., inflammatory symptoms) focuses on prescribing medications to control inflammation. However, the vast majority of IBD management occurs between clinic visits, demanding patients’ active participation in their care. To decrease symptoms and maximize quality of life, IBD patients need to master self-management— the daily behaviors they must perform to keep their illness under control, minimize its impact on their health, and cope with comorbid psychological symptoms. IBD-focused self-management interventions hold promise for improving IBD-related quality of life. However, existing IBD interventions are not based in established theory, and focus solely on cognitive behavioral therapy or a specific skill, limiting their impact. Further, they are understudied in patients with active IBD. Research aims: This K23 proposes to develop a self-led digital self- management intervention for active IBD that will be designed for delivery as part of gastroenterological care. The central hypothesis is that a theory-driven evidence-based self-management intervention that meets both the behavioral and psychosocial needs of patients with active IBD (including confidence, motivation, and skills) will improve IBD-related quality of life and health outcomes. The current research will focus on intervention development, laying the foundation for testing this hypothesis. In this study, intervention development will be guided by the ADAPT-ITT model, a process for adapting evidence-based interventions to create self- management interventions for target populations. Aim 1 will use qualitative methods to develop an in-depth understanding of factors that affect IBD symptoms and quality of life, and patient preferences related to the design and delivery of a self-management intervention. Aim 2 will focus on designing and pre-testing the content and structure of an IBD self-management intervention. Aim 3 will pilot test the IBD self-management intervention to establish clinical trial feasibility. This process is iterative but not interdependent, providing pilot data for an R01 submission to conduct a larger-scale efficacy study. Training aims: Dr. Cohen-Mekelburg will develop expertise in (1) select behavioral intervention research concepts to develop self-management interventions for gastrointestinal conditions, (2) qualitative methods to inform intervention development, and (3) clinical trial methods for intervention evaluation. In addition to coursework and seminars, Dr. Cohen-Mekelburg will be guided by a strong mentorship team with a history of collaboration and success. Environment: University of Michigan offers the ideal environment for this training, with strong institutional commitment and interdisciplinary institutes.

PROJECT NARRATIVE To decrease symptom burden and maximize their quality of life, inflammatory bowel disease (IBD) patients need to master skills that facilitate self-management—the daily behaviors individuals must perform to keep their illness under control, minimize its impact on their physical health, and cope with comorbid or resulting psychological symptoms. In alignment with the National Institute of Health’s mission to improve people’s health and quality of life, this study proposes to develop an intervention that is designed to support patients with active IBD in self- management and improve their care, symptoms, and quality of life. This approach will provide insights for feasible and acceptable self-management interventions with adaptability to diverse IBD populations.