0314 Design of a Continuous Melatonin Monitoring System: A Needs Assessment for Direct and Indirect Users

Abstract Introduction Circadian misalignment can interact bidirectionally with existing chronic conditions, especially those affecting the physical-cognitive boundary, in a manner causing progressive degradation of the chronic condition and circadian health. Current techniques for detecting circadian misalignment involve salivary, serum, or urinary melatonin testing or applying machine learning to accelerometry and heart rate data from wearable devices, and have considerable limitations affecting accessibility, generalizability, and real-time intervention. A continuous, patient-facing melatonin monitoring device (CMM) offers an alternative detection method while also supporting patients in performing real-time self-care tasks to improve their circadian alignment, sleep health, and wider health outcomes. Systematic design processes emphasize the importance of identifying end-user needs to derive specific design system requirements. Methods Three relevant frameworks were to support a process for stakeholder needs assessment to improve circadian / sleep management. Diffusion of innovations addresses factors that impact the adoption of an idea or product through social networks. Health literacy framework references patient knowledge and beliefs that influence health behaviors and outcomes. The chronic care model considers community and health system factors affecting interactions between patients and provider teams. These frameworks were adapted to a sleep health context and used to develop the NAP-CART (Needs Assessment Protocol for a Circadian Assessment and Realignment Tool). Results The NAP-CART involves performing semi-structured interviews with direct users (patients) and indirect users (sleep researchers and clinicians), with 15-20 subjects of each. Patient interviews using interface drafts will focus on health literacy specific to circadian alignment and melatonin, user interaction preferences for both short-term and sustained use, including broader issues of health management. Inclusion of indirect users will inform device use for research or clinical settings, but also provider interactions with patients specific to melatonin data, as patients are unlikely to have had previous interactions with melatonin data. Indirect user interviews will also consider the prospective role of CMM in research, clinical care, and decision-making support. Conclusion User-centered needs assessments for NAP-CART go beyond technical design of the CMM physical sensor. Incorporating end-user needs, previous experiences, and preferences into the systematic development of specific, measurable design requirements facilitates both initial adoption and sustained use for patients and clinicians. Support (if any)