Jones Fiona, Gage Heather, Drummond Avril, Bhalla Ajay, Grant Robert, Lennon Sheila, McKevitt Christopher, Riazi Afsane, Liston Matthew
Faculty of Health, Social Care and Education, Kingston University and St George's, University of London, London, UK.
School of Economics, University of Surrey, Surrey, UK.
BMJ Open. 2016 Jan 6;6(1):e008900. doi: 10.1136/bmjopen-2015-008900.
To test the feasibility of conducting a controlled trial into the effectiveness of a self-management programme integrated into stroke rehabilitation.
A feasibility cluster-randomised design was utilised with stroke rehabilitation teams as units of randomisation.
Community-based stroke rehabilitation teams in London.
78 patients with a diagnosis of stroke requiring community based rehabilitation.
The intervention consisted of an individualised approach to self-management based on self-efficacy. Clinicians were trained to integrate defined self-management principles into scheduled rehabilitation sessions, supported by a patient-held workbook.
Patient measures of quality of life, mood, self-efficacy and functional capacity, and health and social care utilisation, were carried out by blinded assessors at baseline, 6 weeks and 12 weeks. Fidelity and acceptability of the delivery were evaluated by observation and interviews.
4 community stroke rehabilitation teams were recruited, and received a total of 317 stroke referrals over 14 months. Of these, 138 met trial eligibility criteria and 78 participants were finally recruited (56.5%). Demographic and baseline outcome measures were similar between intervention and control arms, with the exception of age. All outcome measures were feasible to use and clinical data at 12 weeks were completed for 66/78 participants (85%; 95% CI 75% to 92%). There was no significant difference in any of the outcomes between the arms of the trial, but measures of functional capacity and self-efficacy showed responsiveness to the intervention. Observation and interview data confirmed acceptability and fidelity of delivery according to predetermined criteria. Costs varied by site.
It was feasible to integrate a stroke self-management programme into community rehabilitation, using key principles. Some data were lost to follow-up, but overall results support the need for conducting further research in this area and provide data to support the design of a definitive trial.
ISRCTN42534180.
测试开展一项关于整合到中风康复中的自我管理计划有效性的对照试验的可行性。
采用可行性整群随机设计，以中风康复团队作为随机分组单位。
伦敦的社区中风康复团队。
78名被诊断为中风且需要社区康复的患者。
干预包括基于自我效能的个体化自我管理方法。临床医生接受培训，将明确的自我管理原则融入到预定的康复疗程中，并辅以患者持有的工作手册。
由盲法评估人员在基线、6周和12周时对患者的生活质量、情绪、自我效能和功能能力以及健康和社会护理利用情况进行测量。通过观察和访谈评估干预实施的保真度和可接受性。
招募了4个社区中风康复团队，在14个月内共收到317例中风转诊病例。其中，138例符合试验纳入标准，最终招募了78名参与者（56.5%）。除年龄外，干预组和对照组的人口统计学和基线结局指标相似。所有结局指标均可行使用，78名参与者中有66名（85%；95%CI 75%至92%）完成了12周时的临床数据收集。试验组之间在任何结局指标上均无显著差异，但功能能力和自我效能指标显示出对干预的反应性。观察和访谈数据证实了根据预定标准实施的可接受性和保真度。成本因地点而异。
使用关键原则将中风自我管理计划整合到社区康复中是可行的。一些数据失访，但总体结果支持在该领域开展进一步研究的必要性，并为确定性试验的设计提供数据支持。
ISRCTN42534180
