O' Donoghue Mairéad, Boland Pauline, Taylor Sinead, Hennessy Edel, Murphy Eva, Leahy Siobhan, McManus John, Lisiecka Dominika, Purtill Helen, Galvin Rose, Hayes Sara
School of Allied Health, Faculty of Education and Health Sciences, Ageing Research Centre, Health Research Institute, University of Limerick, Limerick, V94 T9PX, Ireland.
Acute Stroke and Neurology Services, UL Hospitals Group, University Hospital Limerick, Limerick, Ireland.
Pilot Feasibility Stud. 2023 Oct 18;9(1):178. doi: 10.1186/s40814-023-01300-7.
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.
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.
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).
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.
NCT05414539.
中风是全球死亡和残疾的主要原因。尽管中风后认知障碍普遍存在且负担沉重，但对于中风后患者的最佳认知康复方法仍存在不确定性。本研究旨在评估一种名为OptiCogs的多组分干预措施对中风后认知障碍患者是否可行、可接受且安全。次要目的是探讨从干预前到干预后认知功能、疲劳、生活质量、身体功能和职业表现的变化。
进行了一项可行性研究，中风后有认知障碍的患者参加了为期6周的多组分干预。记录的主要结局包括反应率、招募率、保留率、对干预方案的依从性、不良事件以及中风后患者对干预的可接受性。次要结局包括：（i）使用Addenbrooke认知检查III评估认知功能的变化；（ii）使用疲劳严重程度量表评估疲劳；（iii）使用中风特异性生活质量量表评估生活质量；（iv）使用患者报告结局测量信息系统评估身体功能；（v）使用加拿大职业表现测量量表评估患者报告的职业表现。遵循试验注册报告统一标准扩展报告指南，用于试点和可行性研究，以规范本研究的实施和报告。
反应率为10.9%。在4个月的招募期内，有9名符合条件的参与者入组，其中8名参与者完成了整个6周的干预以及干预前和干预后的结局测量。未报告不良事件。参与者对干预感到满意，总体上认为可以接受。次要结局的结果显示，认知功能（ACE III，干预前：63.3±23.9，干预后：69±24.6）、疲劳（FSS，干预前：52.5±7.3，干预后：45.6±7.2）、生活质量（SSQoL，干预前：131.0±26.3，干预后：169.9±15.3）、身体功能（PROMIS-PF，干预前：15.5±6.3，干预后：15.8±5.3）以及职业表现（COPM表现，干预前：9.3±2.3，干预后：22.9±4.2）和COPM满意度（干预前：9.9±2.1，干预后：22.7±3.5）均有改善。
初步结果表明，OptiCogs干预的招募率较低但保留率较高。从干预前到干预后，认知功能、疲劳、生活质量和自我报告的职业表现均有改善。这些潜在益处需要在更大规模的试点试验中进一步测试。
NCT05414539
