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首页> 外文期刊>Pilot and Feasibility Studies >Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR): study protocol for a phase II randomised feasibility study of a multidisciplinary rehabilitation package following hip fracture [ISRCTN22464643]
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Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR): study protocol for a phase II randomised feasibility study of a multidisciplinary rehabilitation package following hip fracture [ISRCTN22464643]

机译：老年人多学科康复治疗（FEMuR）中的骨折：髋部骨折后多学科康复治疗套餐的II期随机可行性研究的研究方案[ISRCTN22464643]

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Proximal femoral fracture is a common, major health problem in old age resulting in loss of functional independence and a high-cost burden on society, with estimated health and social care costs of ￡2.3 billion per year in the UK. Rehabilitation has the potential to maximise functional recovery and maintain independent living, but evidence of effectiveness is lacking. Usual rehabilitation care is delivered by a multi-disciplinary team in the hospital and in the community. An ‘enhanced rehabilitation’ intervention has been developed consisting of a workbook, goal-setting diary and extra therapy sessions, designed to improve self-efficacy and increase the amount and quality of the practice of physical exercise and activities of daily living.Methods/designThis paper describes the design of a phase II study comprising an anonymous cohort of all proximal femoral fracture patients admitted to the three acute hospitals in Betsi Cadwaladr University Health Board over a 6-month period with a randomised feasibility study comparing the enhanced rehabilitation intervention with usual care. These will assess the feasibility of a future definitive randomised controlled trial and concurrent economic evaluation in terms of recruitment, retention, outcome measure completion, compliance with the intervention and fidelity of delivery, health service use data, willingness to be randomised and effect size for a future sample size calculation. Focus groups will provide qualitative data to contribute to the assessment of the acceptability of the intervention amongst patients, carers and rehabilitation professionals and the feasibility of delivering the planned intervention. The primary outcome measure is function assessed by the Barthel Index. Secondary outcomes measure the ability to perform activities of daily living, anxiety and depression, potential mediators of outcomes such as hip pain, self-efficacy and fear of falling, health utility, health service use, objectively assessed physical function and adverse events. Participants’ preference for rehabilitation services will be assessed in a discrete choice experiment.DiscussionPhase II studies are an opportunity to not only assess the feasibility of trial methods but also to compare different methods of outcome measurement and novel methods of obtaining health service use data from routinely collected patient information.Trial registrationCurrent Controlled Trials ISRCTN22464643, UKCRN16677.
机译：股骨近端骨折是老年人常见的主要健康问题，会导致功能独立性丧失和社会负担沉重，估计英国每年的健康和社会护理费用为23亿英镑。康复有可能最大限度地恢复功能并维持独立生活，但缺乏有效性的证据。通常的康复护理由医院和社区的多学科团队提供。已经开发了一种``增强康复''干预措施，包括工作手册，设定目标的日记和额外的治疗课程，旨在提高自我效能并提高体育锻炼和日常生活活动的数量和质量。论文描述了一项II期研究的设计，该研究包括一个匿名队列，对所有在6个月内进入Betsi Cadwaladr大学卫生委员会三所急诊医院的股骨近端骨折患者进行研究，并进行了一项随机可行性研究，比较了加强康复干预与常规护理。这些将评估未来确定性随机对照试验和同时进行的经济评估的可行性，包括招募，保留，结果测量完成，对干预措施的遵从性和交付的忠诚度，卫生服务使用数据，随机化的意愿以及对患者的影响大小。将来的样本量计算。焦点小组将提供定性数据，以帮助评估患者，护理人员和康复专业人员之间的干预措施的可接受性以及提供计划的干预措施的可行性。主要结局指标是通过Barthel指数评估的功能。次要结局指标是进行日常生活活动，焦虑和抑郁活动的能力，可能的结局中介因素，如髋关节疼痛，自我效能感和对跌倒的恐惧，保健效用，保健服务使用，客观评估的身体机能和不良事件。参与者对康复服务的偏好将通过离散选择实验进行评估。讨论阶段II的研究不仅提供了评估试验方法可行性的机会，而且还可以比较不同的结果测量方法以及从常规方法获取卫生服务使用数据的新颖方法收集的患者信息。试验注册当前对照试验ISRCTN22464643，UKCRN16677。

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