The REFORM study protocol: a cohort randomised controlled trial of a multifaceted podiatry intervention for the prevention of falls in older people
The REFORM study protocol: a cohort randomised controlled trial of a multifaceted podiatry intervention for the prevention of falls in older people
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DOI：
10.1136/bmjopen-2014-006977
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发表时间：
2014-01-01
期刊：
影响因子：
2.9
通讯作者：
Torgerson, David
中科院分区：
文献类型：
--
作者：
Cockayne, Sarah;Adamson, Joy;Torgerson, David
简介：福尔斯和与跌倒有关的伤害是一个严重的原因，发病率和社会成本。足部问题和不适当的鞋类可能会增加福尔斯的风险;因此，足病干预可能在减少福尔斯方面发挥作用。两项科克伦系统评价仅确定了一项旨在减少福尔斯跌倒的足病干预研究，该研究在澳大利亚进行。改革试验的目的是评估的临床和成本效益的多方面足病干预措施，减少福尔斯在65岁以上的人在英国和爱尔兰setting.Methods和分析：这多中心，队列随机对照试验将招募2600名参与者从常规足病诊所在英国和爱尔兰的改革队列。为了检测福尔斯从50%降低至40%的10%点，890例受试者将随机接受常规足病护理和福尔斯预防传单或常规足病护理、福尔斯预防传单和多方面足病干预，把握度为80%。主要结局是通过患者自我报告福尔斯日记评估的12个月内的福尔斯发生率（福尔斯/人/时间）。次要自我报告结局指标包括：12个月内单次和多次跌倒者的比例以及首次跌倒的时间;短期福尔斯疗效量表-国际;过去4周内对跌倒的恐惧;弗伦谢活动指数;骨折率;老年抑郁量表; EuroQoL-五维量表3-L; 6个月和12个月时的卫生服务利用率。一项定性研究将审查的可接受性的一揽子护理参与者和足病学家。伦理和传播：该试验已收到了有利的意见，从东英格兰剑桥东研究伦理委员会和高威研究伦理委员会。试验结果将发表在同行评审期刊和会议报告上。
Introduction: Falls and fall-related injuries are a serious cause of morbidity and cost to society. Foot problems and inappropriate footwear may increase the risk of falls; therefore podiatric interventions may play a role in reducing falls. Two Cochrane systematic reviews identified only one study of a podiatry intervention aimed to reduce falls, which was undertaken in Australia. The REFORM trial aims to evaluate the clinical and cost-effectiveness of a multifaceted podiatry intervention in reducing falls in people aged 65 years and over in a UK and Irish setting.Methods and analysis: This multicentre, cohort randomised controlled trial will recruit 2600 participants from routine podiatry clinics in the UK and Ireland to the REFORM cohort. In order to detect a 10% point reduction in falls from 50% to 40%, with 80% power 890 participants will be randomised to receive routine podiatry care and a falls prevention leaflet or routine podiatry care, a falls prevention leaflet and a multifaceted podiatry intervention. The primary outcome is rate of falls (falls/person/time) over 12 months assessed by patient self-report falls diary. Secondary self-report outcome measures include: the proportion of single and multiple fallers and time to first fall over a 12-month period; Short Falls Efficacy Scale-International; fear of falling in the past 4 weeks; Frenchay Activities Index; fracture rate; Geriatric Depression Scale; EuroQoL-five dimensional scale 3-L; health service utilisation at 6 and 12 months. A qualitative study will examine the acceptability of the package of care to participants and podiatrists.Ethics and dissemination: The trial has received a favourable opinion from the East of England-Cambridge East Research Ethics Committee and Galway Research Ethics Committee. The trial results will be published in peer-reviewed journals and at conference presentations.