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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

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posted on 2024-01-31, 14:09 authored by Emma Carr, Aoife WhistonAoife Whiston, Siobhan O'Reilly, Mairead O'DonoghueMairead O'Donoghue, Nathan Cardy, Daniel Carter, LIAM GLYNNLIAM GLYNN, Jane C Walsh, JOHN F FORBESJOHN F FORBES, CATHAL WALSHCATHAL WALSH, John McManus, Andrew Hunter, Mike Butler, Lorna Paul, Claire Fitzsimons, Julie Bernhardt, ITA RICHARDSONITA RICHARDSON, James G Bradley, Jon Salsberg, SARA HAYESSARA HAYES

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.

Trials registration number NCT05606770


Funding

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

Health Research Board

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History

Publication

BMJ Open 2024,14:e072811

Publisher

BMJ Publishing Group

Also affiliated with

  • Health Research Institute (HRI)

Sustainable development goals

  • (3) Good Health and Well-being

Department or School

  • Allied Health
  • School of Medicine

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