Sequential multiple assignment randomised trial to develop an adaptive mobile health intervention to increase physical activity in people poststroke in the community setting in Ireland: TAPAS trial protocol

Author:

Carr Emma,Whiston Aoife,O'Reilly Siobhan,O Donoghue Mairead,Cardy NathanORCID,Carter Daniel,Glynn Liam,Walsh Jane C,Forbes John,Walsh Cathal,McManus John,Hunter Andrew,Butler Mike,Paul Lorna,Fitzsimons Claire,Bernhardt JulieORCID,Richardson Ita,Bradley James G,Salsberg JonORCID,Hayes SaraORCID

Abstract

IntroductionStroke is the second-leading cause of death and disability globally. Participation in physical activity (PA) is a cornerstone of secondary prevention in stroke care. Given the heterogeneous nature of stroke, PA interventions that are adaptive to individual performance are recommended. Mobile health (mHealth) has been identified as a potential approach to supporting PA poststroke. To this end, we aim to use a Sequential Multiple Assignment Randomised Trial (SMART) design to develop an adaptive, user-informed mHealth intervention to improve PA poststroke.Methods and analysisThe components included in the 12-week intervention are based on empirical evidence and behavioural change theory and will include treatments to increase participation in Structured Exercise and Lifestyle or a combination of both. 117 participants will be randomly assigned to one of the two treatment components. At 6 weeks postinitial randomisation, participants will be classified as responders or non-responders based on participants’ change in step count. Non-responders to the initial treatment will be randomly assigned to a different treatment allocation. The primary outcome will be PA (steps/day), feasibility and secondary clinical and cost outcomes will also be included. A SMART design will be used to evaluate the optimum adaptive PA intervention among community-dwelling, ambulatory people poststroke.Ethics and disseminationEthical approval has been granted by the Health Service Executive Mid-Western Ethics Committee (REC Ref: 026/2022). The findings will be submitted for publication and presented at relevant national and international academic conferencesTrials registration numberNCT05606770.

Funder

Health Research Board

Publisher

BMJ

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