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

Emma Carr, Aoife Whiston, Siobhan O'Reilly, Mairead O Donoghue, Nathan Cardy, Daniel Carter, Liam Glynn, Jane C. Walsh, John Forbes, Cathal Walsh, John McManus, Andrew Hunter, Mike Butler, Lorna Paul, Claire Fitzsimons, Julie Bernhardt, Ita Richardson, James G. Bradley, Jon Salsberg, Sara Hayes*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

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Abstract

INTRODUCTION: Stroke 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 ANALYSIS: The 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 DISSEMINATION: Ethical 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 conferences.

Original languageEnglish
Article numbere072811
Pages (from-to)e072811
Number of pages12
JournalBMJ Open
Volume14
Issue number1
DOIs
Publication statusPublished - 18 Jan 2024

ASJC Scopus subject areas

  • General Medicine

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