Background: Management of diabetes through improved glycemic control and risk factor modification can help\nprevent long-term complications. Much diabetes management is self-management, in which healthcare providers\nplay a supporting role. Well-designed e-Health solutions targeting behavior change can improve a range of measures,\nincluding glycemic control, perceived health, and a reduction in hospitalizations.\nMethods: The primary objective of this study is to evaluate if a mobile application designed to improve self-management\namong patients with type 2 diabetes (T2DM) improves glycemic control compared to usual care. The secondary objectives\nare to determine the effects on patient experience and health system costs; evaluate how and why the intervention\nworked as observed; and gain insight into considerations for system-wide scale-up. This pragmatic,\nrandomized, wait-list-control trial will recruit adult participants from three Diabetes Education Programs in\nOntario, Canada. The primary outcome is glycemic control (measured by HbA1c). Secondary outcomes\ninclude patient-reported outcomes and patient-reported experience measures, health system utilization, and\nintervention usability. The primary outcome will be analyzed using an ANCOVA, with continuous secondary\noutcomes analyzed using Poisson regression. Direct observations will be conducted of the implementation\nand application-specific training sessions provided to each site. Semi-structured interviews will be conducted with\nparticipants, healthcare providers, organizational leaders, and system stakeholders as part of the embedded process\nevaluation. Thematic analysis will be applied to the qualitative data in order to describe the relationships between (a)\nkey contextual factors, (b) the mechanisms by which they effect the implementation of the intervention, and (c) the\nimpact on the outcomes of the intervention, according to the principles of Realist Evaluation.\nDiscussion: The use of mobile health and virtual tools is on the rise in health care, but the evidence of their\neffectiveness is mixed and their evaluation is often lacking key contextual data. Results from this study will provide\nmuch needed information about the clinical and cost-effectiveness of a mobile application to improve diabetes\nself-management. The process evaluation will provide valuable insight into the contextual factors that influence the\napplication effectiveness, which will inform the potential for adoption and scale.
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