Adjustment with aphasia after stroke: study protocol for a pilot feasibility randomised controlled trial for SUpporting wellbeing through PEeR Befriending (SUPERB)
Adjustment with aphasia after stroke: study protocol for a pilot feasibility randomised controlled trial for SUpporting wellbeing through PEeR Befriending (SUPERB)
复制标题
DOI：
10.1186/s40814-019-0397-6
复制
发表时间：
2019-01-22
影响因子：
1.7
通讯作者：
Goldsmith, Kimberley
中科院分区：
文献类型：
--
作者：
Hilari, Katerina;Behn, Nicholas;Goldsmith, Kimberley
背景：尽管中风后情绪问题的患病率很高，但有效干预措施（特别是针对失语症患者）的证据有限。迫切需要系统地评估旨在改善中风和失语症患者福祉的干预措施。本研究旨在评估同伴友好干预的可行性。方法/设计：SUPERB 是一项针对中风后失语症和低水平心理困扰患者的同伴友好的单盲、平行小组可行性试验。该试验包括嵌套定性研究和试点经济评估，并将常规护理 (n = 30) 与常规护理 + 同伴友好 (n = 30) 进行比较。可行性结果包括符合标准的筛查比例、同意比例、同意率、结果测量数据缺失/不完整的数量、随访时的流失率、利用信息分析价值（经济评估）进行主要试验的潜在价值、常规护理的描述以及同伴友好的治疗保真度。将在基线时对参与者和重要其他人进行评估和结果测量（情绪、幸福感、沟通和社会参与），并在随机分组后 4 个月和 10 个月重新进行结果测量。同伴友好者将在培训前和完成两个友好循环后完成结果测量。定性研究将采用半结构化访谈的方式，对试验双方有意抽样的参与者 (n = 20) 和重要的其他人 (n = 10) 以及所有同伴互助者进行访谈，以探讨护理程序和体验的可接受性。试点经济评估将利用欧洲生活质量衡量标准 (EQ-5D-5 L) 和客户服务收据清单 (CSRI) 的中风适应版本。讨论：本研究将提供有关可行性结果的信息，并初步表明同伴友好是否是一种合适的干预措施，以便在最终的 III 期随机对照试验中进一步探索。
Background: Despite the high prevalence of mood problems after stroke, evidence on effective interventions particularly for those with aphasia is limited. There is a pressing need to systematically evaluate interventions aiming to improve wellbeing for people with stroke and aphasia. This study aims to evaluate the feasibility of a peer-befriending intervention.Methods/design: SUPERB is a single blind, parallel group feasibility trial of peer befriending for people with aphasia post-stroke and low levels of psychological distress. The trial includes a nested qualitative study and pilot economic evaluation and it compares usual care (n = 30) with usual care + peer befriending (n = 30). Feasibility outcomes include proportion screened who meet criteria, proportion who consent, rate of consent, number of missing/incomplete data on outcome measures, attrition rate at follow-up, potential value of conducting main trial using value of information analysis (economic evaluation), description of usual care, and treatment fidelity of peer befriending. Assessments and outcome measures (mood, wellbeing, communication, and social participation) for participants and significant others will be administered at baseline, with outcome measures re-administered at 4 and 10 months post-randomisation. Peer befrienders will complete outcome measures before training and after they have completed two cycles of befriending. The qualitative study will use semi-structured interviews of purposively sampled participants (n = 20) and significant others (n = 10) from both arms of the trial, and all peer befrienders to explore the acceptability of procedures and experiences of care. The pilot economic evaluation will utilise the European Quality of life measure (EQ-5D-5 L) and a stroke-adapted version of the Client Service Receipt Inventory (CSRI).Discussion: This study will provide information on feasibility outcomes and an initial indication of whether peer befriending is a suitable intervention to explore further in a definitive phase III randomised controlled trial.