Perspectives of People with Stroke, Caregivers and Healthcare Professionals on an Adaptive mHealth Intervention for Physical Activity in the Prevention of Secondary Stroke: A Qualitative Study.

Introduction: Engaging in regular physical activity (PA) is associated with lower mortality following stroke, and PA reduces the chance of recurrent stroke. Despite recent guidelines to optimise PA following stroke, people with stroke are known to be less active than their age-matched counterparts. Given the heterogenous nature of stroke, adaptive PA interventions are recommended for people with stroke. Empirical data is lacking on adaptive PA or behavioural change interventions following stroke. Suggested strategies in the prevention of stroke recommend the use of mobile health (mHealth) interventions in the primary prevention of stroke. A structured stakeholder consultation process is key to successful implementation of complex interventions. This paper reports the findings of our consultation process to inform the development of an adaptive mHealth PA. Methods: We used a qualitative study design to explore the perspectives of key stakeholders on the development of an adaptive PA intervention delivered via mHealth post-stroke. Healthcare workers, carers and people with stroke participated in semi-structured one-to-one or focus group interviews. A reflexive thematic analysis was undertaken on transcribed interviews; key themes and sub-themes were developed using coding and summarised by two researchers, then reviewed by the full research team. Results: Twenty-eight stakeholders were interviewed and three main themes were identified; Key feature of a mHealth intervention, delivering a mHealth intervention, Challenges to development and use. There was widespread agreement across stakeholder groups that an adaptive mHealth PA intervention following stroke would be beneficial to people with stroke, following discharge from acute care. Conclusion: Our consultation supports the development of an adaptive PA programme that addresses specific impairments that can hinder exercise participation after stroke.

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.

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.

OptiCogs: feasibility of a multicomponent intervention to rehabilitate people with cognitive impairment post-stroke.

BACKGROUND: Stroke is a leading cause of death and disability worldwide. Despite the prevalence and associated burden of cognitive impairment post-stroke, there is uncertainty regarding optimal cognitive rehabilitation for people post-stroke. This study aimed to assess whether a multicomponent intervention, called OptiCogs, is feasible, acceptable, and safe for people with cognitive impairment post-stroke. A secondary aim was to explore changes in cognitive function, fatigue, quality of life, physical function, and occupational performance, from pre-intervention to post-intervention. METHODS: A feasibility study was conducted where people post-stroke with cognitive impairment enrolled in a 6-week multicomponent intervention. The primary outcomes recorded included response rate, recruitment rate, retention rate, adherence to the intervention protocol, adverse events, and acceptability of the intervention to people post-stroke. Secondary outcomes included (i) change in cognitive functioning using the Addenbrooke's Cognitive Examination III, (ii) fatigue using the Fatigue Severity scale, (iii) quality of life using the Stroke Specific Quality of Life scale (iv) physical function using the patient-reported outcomes measurement information system, and (v) patient-reported occupational performance using the Canadian Occupational Performance Measure. The Consolidated Standards of Reporting Trials extension reporting guidelines were followed, for pilot and feasibility studies, to standardize the conduct and reporting of this study. RESULTS: The response rate was 10.9%. Nine eligible participants were enrolled during the 4-month recruitment period, with eight participants completing the entire 6-week intervention, as well as the pre- and post-intervention outcome measures. There were no reported adverse events. Participants were satisfied with the intervention and found it acceptable overall. Results of the secondary outcomes were promising for cognitive function (ACE III, pre: 63.3 ± 23.9 to post: 69 ± 24.6), fatigue (FSS, pre: 52.5 ± 7.3 to post: 45.6 ± 7.2), quality of life (SSQoL, pre: 131.0 ± 26.3 to post: 169.9 ± 15.3), physical function (PROMIS-PF, pre: 15.5 ± 6.3 to post: 15.8 ± 5.3), and occupational performance (COPM performance, pre: 9.3 ± 2.3 to post: 22.9 ± 4.2) and COPM satisfaction, pre: 9.9 ± 2.1 to post: 22.7 ± 3.5). CONCLUSION: Preliminary results suggest low-modest recruitment and high retention rates for the OptiCogs intervention. Changes in cognitive function, fatigue, quality of life, and self-reported occupational performance show improvement from pre- to post-intervention. These potential benefits require further testing in a larger pilot trial. TRIAL REGISTRATION: NCT05414539.

Exploring the perspectives of key stakeholders on the design and delivery of a cognitive rehabilitation intervention for people post-stroke.

PURPOSE: Stroke is a leading cause of death and disability worldwide. Despite the prevalence and associated burden of post-stroke cognitive impairment, there is uncertainty regarding optimum interventions to improve cognitive function in people post-stroke. The aim of this study is to explore the perspectives of key stakeholders on the design and development of a multidisciplinary intervention to rehabilitate cognitive deficits in people post-stroke. MATERIALS AND METHODS: Audio-recorded, semi-structured interviews were employed with people post-stroke, caregivers, healthcare professionals and academics. All transcribed interviews were exported to NVivo software and analysed using reflexive thematic analysis. RESULTS: Thirty interviews were conducted across stakeholder groups including people post-stroke (n = 10), caregivers (n = 5), healthcare professionals (n = 14) and academics (n = 1). Four themes relevant to the design and development of the intervention were identified (i) engagement in the intervention must be meaningful, (ii) the point of readiness to engage, (iii) a familiar but flexible setting is key (iv) pragmatics of intervention delivery. CONCLUSIONS: These findings present new perspectives across stakeholder groups on the design and delivery of an intervention to rehabilitate cognitive deficits in people post-stroke. Taken together with existing quantitative evidence, these findings will inform the development of a feasibility trial, examining patient and process outcomes, to rehabilitate cognitive deficits post-stroke.

Rehabilitation of Cognitive Deficits Poststroke: Systematic Review and Meta-Analysis of Randomized Controlled Trials.

BACKGROUND: Despite the prevalence of cognitive impairment poststroke, there is uncertainty regarding interventions to improve cognitive function poststroke. This systematic review and meta-analysis evaluate the effectiveness of rehabilitation interventions across multiple domains of cognitive function. METHODS: Five databases were searched from inception to August 2019. Eligible studies included randomized controlled trials of rehabilitation interventions for people with stroke when compared with other active interventions or standard care where cognitive function was an outcome. RESULTS: Sixty-four randomized controlled trials (n=4005 participants) were included. Multiple component interventions improved general cognitive functioning (MD, 1.56 [95% CI, 0.69-2.43]) and memory (standardized MD, 0.49 [95% CI, 0.27-0.72]) compared with standard care. Physical activity interventions improved neglect (MD, 13.99 [95% CI, 12.67-15.32]) and balance (MD, 2.97 [95% CI, 0.71-5.23]) compared with active controls. Noninvasive brain stimulation impacted neglect (MD, 20.79 [95% CI, 14.53-27.04) and functional status (MD, 14.02 [95% CI, 8.41-19.62]) compared with active controls. Neither cognitive rehabilitation (MD, 0.37 [95% CI, -0.94 to 1.69]) nor occupational-based interventions (MD, 0.45 [95% CI, -1.33 to 2.23]) had a significant effect on cognitive function compared with standard care. CONCLUSIONS: There is some evidence to support multiple component interventions, physical activity interventions, and noninvasive brain stimulation improving cognitive function poststroke. Findings must be interpreted with caution given the overall moderate to high risk of bias, heterogeneity of interventions, and outcome measures across studies.

Exploring the perspectives of key stakeholders on the design and delivery of an intervention to rehabilitate people with cognitive deficits post-stroke.

Background: Stroke is a leading cause of death and disability worldwide. Cognitive impairment is common post-stroke and can result in negative sequalae such as a lower quality of life, increased carer burden and increased healthcare costs. Despite the prevalence and associated burden of post-stroke cognitive impairment, there is uncertainty regarding the optimum intervention to improve cognitive function post-stroke. By exploring the perspectives of people post-stroke, carers and healthcare professionals on cognitive impairment, this qualitative study aims to inform the design and development of an intervention to rehabilitate cognitive impairment post-stroke. Methods: A qualitative descriptive approach will be applied, using semi-structured interviews with people post-stroke, carers and healthcare professionals. People post-stroke will be recruited via gatekeepers from a local stroke support group and Headway, a brain injury support service. Carers will be recruited via a gatekeeper from a local carers branch. Healthcare professionals will be recruited via gatekeepers from relevant neurological sites and via Twitter. The final number of participants recruited will be guided by information power. Data will be collectively analysed and synthesised using thematic analysis. The Consolidated Criteria for Reporting Qualitative Studies (COREQ) guidelines will be used to standardize the conduct and reporting of the research. Conclusions: It is anticipated that exploring the perspectives of people post-stroke, carers and healthcare professionals on cognitive impairment post-stroke will inform the development of an evidence-based optimal intervention to rehabilitate cognitive deficits post-stroke. This study was granted ethical approval from the Faculty of Education and Health Sciences Research Ethics Committee at the University of Limerick. Study findings will be disseminated locally through presentations at stroke support groups, as well as internationally through academic conferences and peer-reviewed journals.

Rehabilitation of cognitive deficits poststroke: protocol for a systematic review and meta-analysis of randomised controlled trials of non-pharmacological interventions.

INTRODUCTION: Stroke is among the leading causes of death and disability worldwide. Poststroke cognitive impairment is a common sequela of stroke. The burden of cognitive impairment poststroke has significant impacts on the individual poststroke, their family and wider society. Despite the prevalence and associated burden of poststroke cognitive impairment, the optimal approach to rehabilitate cognitive deficits poststroke has yet to be established. A range of conservative interventions for cognitive impairment poststroke exist including self-efficacy training, physical activity interventions, neuropsychological interventions, electronic interventions, music therapy and occupational therapies. This systematic review aims to explore the totality of evidence with regard to non-pharmacological rehabilitation interventions wherein the primary or secondary aim is to improve cognitive function in individuals poststroke. METHODS AND ANALYSIS: A systematic review of randomised controlled trials which investigate the effectiveness of interventions wherein the primary or secondary aim is to improve cognitive function in individuals poststroke will be conducted (August 2019). The following electronic databases will be searched: PubMed, Embase, CINAHL, CENTRAL and PsycInfo. Reference lists of all identified studies will be reviewed to identify additional studies for inclusion. Titles and abstracts will be screened independently by two review authors for inclusion and exclusion. Any disagreement regarding inclusion will be resolved by discussion or by referral to a third assessor if necessary. Methodological quality will be assessed using the Cochrane Risk of Bias Tool for Randomised Controlled Trials. Meta-analyses will be performed if studies are sufficiently homogeneous. The review will be reported in accordance to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. ETHICS AND DISSEMINATION: As this systematic review will collect secondary data only, ethical approval is not required. Findings will be disseminated through presentations and peer-reviewed journals. TRIAL REGISTRATION NUMBER: CRD42019125289.