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The adaptive physical activity programme in stroke (TAPAS): protocol for a process evaluation in a sequential multiple assignment randomised trial

Por: Rocliffe · P. · Whiston · A. · O Mahony · A. · OReilly · S. M. · OConnor · M. · Cunningham · N. · Glynn · L. · Walsh · J. C. · Walsh · C. · Hennessy · E. · Murphy · E. · Hunter · A. · Butler · M. · Paul · L. · Fitzsimons · C. F. · Richardson · I. · Bradley · J. G. · Salsberg · J. · Hayes
Introduction

Participation in physical activity (PA) is a cornerstone of the secondary prevention of stroke. Given the heterogeneous nature of stroke, PA interventions that are adaptive to individual performance capability and associated co-morbidity levels are recommended. Mobile health (mHealth) has been identified as a potential approach to supporting PA post-stroke. To this end, we used a Sequential Multiple Assignment Randomised Trial design to develop an adaptive, mHealth intervention to improve PA post-stroke – The Adaptive Physical Activity programme in Stroke (TAPAS) (Clinicaltrials.Gov NCT05606770). As the first trial in stroke recovery literature to use this design, there is an opportunity to conduct a process evaluation for this type of adaptive intervention. The aim of this process evaluation is to examine the implementation process, mechanism of change and contextual influences of TAPAS among ambulatory people with stroke in the community.

Methods and analysis

Guided by the Medical Research Council Framework for process evaluations, qualitative and quantitative methods will be used to examine the (1) implementation process and the content of TAPAS (fidelity adaptation, dose and reach); (2) mechanisms of change (participants’ response to the intervention; mediators; unexpected pathways and consequences) and (3) influence of the context of the intervention. Quantitative data will be presented descriptively, for example, adherence to exercise sessions. Qualitative data will be collected among TAPAS participants and the interventionist using semi-structured one-to-one or focus group interviews. Transcribed interviews will be analysed using reflexive thematic analysis. Key themes and sub-themes will be developed.

Ethics and dissemination

Ethical approval has been granted by the Health Service Executive Mid-Western Ethics Committee (REC Ref: 026/2022) (25/03/2024). The findings will be submitted for publication and presented at relevant national and international academic conferences.

Views of knowledge users on recurrent miscarriage services and supports in the Republic of Ireland: a qualitative interview study

Por: Hennessy · M. · Dennehy · R. · Matvienko-Sikar · K. · OSullivan-Lago · R. · Ui Dhubhgain · J. · Lucey · C. · ODonoghue · K.
Objectives

Women and men/partners who experience miscarriage often report poor care experiences within health services around the time of miscarriage and beyond; less is known about recurrent miscarriage (RM) care. Research is needed to explore the potential targets for improvement, in addition to identifying factors that support or hinder service improvement efforts and the implementation and/or sustainment of desired models of RM care. This study aimed to explore the views of knowledge users regarding RM services and supports; specifically: (a) practices and experiences and (b) facilitators and barriers to providing desired services and supports.

Study design

We adopted a qualitative study design underpinned by constructivism, incorporating semistructured interviews. Data were analysed using reflexive thematic analysis.

Setting

Participants were recruited across the Republic of Ireland, incorporating perspectives from different geographical areas, hospital types and RM services.

Participants

We interviewed 13 women and 7 men/partners who had experienced ≥2 consecutive miscarriages, and 42 people involved in the delivery and/or management of RM services and supports, between June 2020 and February 2021.

Results

We generated three themes from the data: (1) dedicated staff; (2) dedicated space and time and (3) dedicated funding and support—prioritise RM. Our analysis supports the need for a standardised, dedicated and adequately resourced and supported service. One in which people experiencing RM are offered appropriate, individualised, timely and accessible care and support—beginning following the first miscarriage, and following a graded model. Implementation requires several multilevel actions, including prioritising RM care, adequately funding and resourcing services, enhancing health professional education and support, care coordination within and between hospitals and primary care and improving public awareness of, and addressing stigma surrounding, miscarriage.

Conclusions

Our analysis provides context to ‘good’ and ‘poor’ care experiences and identifies what facilitators and barriers exist to affecting change in RM care within healthcare and broader systems. In light of recent debates regarding how best to deliver RM care, and changing international guidelines, this work provides timely and important knowledge that should be harnessed to inform service improvement efforts in the Republic of Ireland and beyond.

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