Development, Usability Evaluation, and Pilot Feasibility Study of an mHealth Application Supporting Self-Management of Accidental Bowel Leakage, "I'M ABLe"

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Project Summary Millions of Americans suffer from accidental bowel leakage (ABL) and the profound stigma associated with this chronic health problem. ABL negatively impacts personal and family relationships, daily activities, well-being, and quality of life. Worry about visible soiling and odor creates emotional distress, reduces participation in public life and social events, and adds stress during work. The inability of older adults to self-manage ABL often results in nursing home admission. The success of conservative management of ABL depends on self- management (SM) by the patient guided by a plan recommended by an informed healthcare provider. However, in current practice there is a notable lack of resources to support patient SM of ABL. The long-term goal of this research is to reduce ABL severity and symptoms and improve quality of life by supporting SM and promoting effective communication about ABL SM with healthcare (HC) providers. Our first specific aim is to develop and evaluate the usability of a mobile health (mHealth) application (app) as an intervention supporting self-management of ABL, referred to as “I’M ABLe.” The app will be developed based on SM theory, evidenced-based recommendations for ABL management, and input of patients with ABL, investigators, an mHealth app usability expert, and experienced technical staff; the app will be part of an established, private, secure, reliable system of an established, successful company focused on SM, which will fast-track its subsequent availability, distribution, and uptake. Usability will be evaluated during design through post- deployment of the app using standard data from subject experience, self-report outcome tools and analytics from the app, examining outcomes such as learnability, efficiency, errors, and satisfaction. The second aim is to conduct a pilot study using a randomized controlled design to examine the feasibility to recruit, randomize, and retain subjects and collect data on SM outcomes (SM activation, SM support, and ABL status) for a future clinical trial of the effectiveness of the app intervention. Subjects in the pilot study will be randomly assigned to usual care (their HC provider recommended ABL management plan) without the app or usual care with addition of the app use for 8 weeks. This proposal addresses the priority of the strategic plan of the National Institute of Nursing Research, NIH, for improving SM strategies of chronic health conditions to improve patients’ quality of life. This proposal is innovative in applying a state-of-the-art approach and leading edge technology and design to develop a highly personalized intervention that will resolve a significant gap in care for patients with ABL. The outcome of this proposal has potential to transform clinical care for ABL by filling the gap in supporting SM and improving ABL outcomes for more patients.