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.
