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Development and evaluation of an adaptive mobile health physical activity intervention post-stroke: a Sequential Multiple Assignment Randomised Trial

Introduction
Despite advances in acute stroke intervention, secondary prevention strategies are lacking. Physical activity (PA) is the second-largest predictor of stroke and the cornerstone of secondary prevention therapies. Reflective of clinical practice, adaptive interventions involve sequential treatments responsive to individuals performance. Despite guidelines to adapt PA to individuals’ needs, there is no evidence on the empirical development of adaptive PA interventions post-stroke. Systematic reviews demonstrate that the evidence is dominated by standard trial designs, used to evaluate non-adaptive PA interventions. This research programme will make notable original contributions to the literature by designing a first-in-class adaptive PA intervention using an innovative experimental design. This design will permit the delivery of optimal sequences of PA treatments for individuals. Furthermore, by developing a user-informed smartphone application, this study will lead to the design and evaluation of a highly-scalable definitive intervention to reduce the risk of recurrent stroke.
Aim
To use a Sequential Multiple-Assignment Randomised Trial (SMART) design to develop an adaptive, user-informed mobile health PA intervention for people post-stroke. Subsequently this adaptive intervention will be evaluated against a treatment-as-usual control using a standard trial design in a definitive trial.
Methods
Qualitative methods will be used to explore the stakeholders’ perspectives on the content and acceptability of a PA intervention, delivered using a smartphone application post-stroke. Interventions will be based on empirical evidence and behavioural theory and will include treatments to reduce sedentary behaviour, increase lifestyle PA and promote structured exercise. An iterative co-design process will be used to develop a smartphone application for intervention delivery. The primary outcome will be PA (steps/day). A SMART design will be used to evaluate the optimum adaptive PA intervention among people post-mild-to-moderate stroke. An exploration of stakeholders’ perspectives on the acceptability of the intervention will be completed using a qualitative process evaluation. Healthcare costs and benefits will be evaluated. Discussion
This internationally-renowned cross-disciplinary team will make a substantial contribution to stroke recovery research by pioneering the use of a SMART design to empirically construct an adaptive PA intervention for future definitive evaluation. This feasibility work will lead to advances in secondary prevention practice and policy post-stroke.