Wray Faye, Cruice Madeline, Kellar Ian, Forster Anne
Academic Unit for Ageing and Stroke Research, Leeds Institute of Health Sciences, University of Leeds, Leeds, LS2 9JT, UK.
Academic Unit for Ageing and Stroke Research, Bradford Institute for Health Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford Royal Infirmary, Bradford, BD9 6RJ, UK.
Pilot Feasibility Stud. 2025 Jan 30;11(1):11. doi: 10.1186/s40814-024-01589-y.
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).
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.
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.
ISRCTN registry, trial registration number: ISRCTN10401966. Date of registration: 07/10/2023. URL of trial registry record: https://doi.org/10.1186/ISRCTN10401966 .
越来越多的证据支持使用自我管理干预措施来改善中风后的生活质量。然而，失语症中风幸存者在迄今为止的研究中所占比例一直较低。因此，尚不清楚自我管理对该群体是否是一种合适或有效的方法。为了填补这一证据空白，我们专门为中风后第一年的失语症中风幸存者开发了一种支持性自我管理干预措施（“失语症生活”干预）。StarStep研究旨在评估实施和评估该干预措施的可行性（包括参与者招募的可行性、提供促进者培训的可行性、干预措施的可接受性、干预措施实施的保真度以及结果数据的完整性）。
StarStep是一项混合方法、非随机的可行性研究。“失语症生活”干预将由言语和语言治疗师提供便利，并在英格兰北部的两个社区中风团队中实施。我们的目标是招募30名患有失语症的中风幸存者（和/或其家庭成员），且中风后时间≤12个月，以参与该研究的数据收集。在获得知情同意后，参与者将完成一份基线数据收集问卷，其中将包括生活质量、抑郁症状和感知沟通效果的测量。干预后3个月将完成随访问卷。定性数据收集将包括实施小组以及对言语和语言治疗师的半结构化访谈、对患有失语症的中风幸存者（和/或其家庭成员）的半结构化访谈以及对干预措施实施情况的观察。将使用一个联合展示表来整合数据收集各要素的结果，以便考虑总体可行性。
本研究将提供优化数据收集过程以及优化自我管理干预措施的实施和提供所需的信息。可行性数据将为关于推进未来确定性整群随机对照试验以评估该干预措施有效性的决策提供信息。
ISRCTN注册库，试验注册号：ISRCTN10401966。注册日期：2023年10月7日。试验注册记录的网址：https://doi.org/10.1186/ISRCTN10401966 。
