Protocol for a feasibility study evaluating a supported self-management intervention for stroke survivors with aphasia (StarStep study)

Background

There is a growing evidence base to support the use of self-management interventions for improving quality of life after stroke. However, stroke survivors with aphasia have been underrepresented in research to date. It is therefore unclear if self-management is an appropriate or effective approach for this group. To address this gap in the evidence base, we have developed a supported self-management intervention (the ‘Living with Aphasia’ intervention) specifically for stroke survivors with aphasia in the first year after stroke. The StarStep study aims to assess the feasibility of implementing and evaluating the intervention (including the feasibility of participant recruitment, the feasibility of delivering facilitator training, the acceptability of the intervention, the fidelity of intervention delivery and outcome data completeness).

Methods

StarStep is a mixed-methods, non-randomised feasibility study. The Living with Aphasia intervention will be facilitated by speech and language therapists and implemented in two community stroke teams in the north of England. We aim to recruit 30 stroke survivors who have aphasia (and/or their family members) and who are ≤ 12-month post-stroke to participate in data collection for the study. Following informed consent, participants will complete a baseline data collection questionnaire which will include measures of quality of life, symptoms of depression and perceived communicative effectiveness. Follow-up questionnaires will be completed at 3-month post-intervention. Qualitative data collection will include implementation groups and semi-structured interviews with speech and language therapists, semi-structured interviews with stroke survivors with aphasia (and/or their family members) and observations of the delivery of the intervention. A joint display table will be used to integrate findings from each element of data collection in order to consider overall feasibility.

Discussion

This study will provide the information necessary to optimise data collection processes and to optimise the implementation and delivery of the self-management intervention. Feasibility data will inform decision-making regarding progression to a future definitive cluster randomised controlled trial to evaluate the effectiveness of the intervention.

Trial registration

ISRCTN registry, trial registration number: ISRCTN10401966. Date of registration: 07/10/2023. URL of trial registry record: https://doi.org/10.1186/ISRCTN10401966.