A Podiatry Intervention to Reduce Falls in Care Home Residents: Development, Feasibility and Acceptability Study With Exploratory Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- NHS Tayside
- 入组人数
- 47
- 试验地点
- 18
- 主要终点
- Change in falls rate
研究概览
简要总结
This is an exploratory pilot Randomised Controlled Trial (RCT) to investigate the effects of a multifaceted podiatry intervention designed to reduce falls in care homes. The investigators hypothesise that the intervention will reduce the high falls rates present in care homes for older people, compared to usual care.
The results will inform the sample size calculation for a full-scale definitive RCT
详细描述
Background: Falls are a problem in care homes where it is estimated that half of all residents will fall at least once in a year. There is now strong empirical evidence that weakness of the foot muscles and painful foot problems such as corns and/or callus are a contributing factor to falls in this population. These problems are common and reversible; however there have been no trials of podiatry interventions that address these problems to establish whether or not this approach can be effective at reducing falls in care home populations.
Methods: Care home residents meeting the inclusion criteria will be assigned to receive either the intervention (specific foot and ankle exercises, orthoses, footwear). We will then conduct an exploratory randomised controlled trial (RCT) with the aim of acquiring data that will inform the design of a subsequent full scale RCT. The groups will then be compared on a number of balance and falls related outcomes.
Main Outcome: The results will indicate the effect size to allow a sample size calculation for a later definitive trial to be conducted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •65 Years or older permanently living in care homes for older people
- •One or more falls in the previous year.
- •Foot problem that is within the scope of podiatry care
排除标准
- •Residents who are terminally unwell or too frail to be included
- •Residents who are only able to mobilise with the use of a wheelchair
- •Temporary residents (for example, those in respite care)
- •Unable to provide informed consent
- •Lower limb Amputees
结局指标
主要结局
Change in falls rate
时间窗: 3 months from baseline measures, 6 months from baseline, 9 months from baseline
A fall will be defined as "an unexpected event in which the participant comes to rest on the ground, floor, or lower level"
次要结局
- Physical Functioning: Barthel Index(Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline)
- Foot and Ankle Strength(Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline)
- Functional Balance: Berg Balance Scale(Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline)
- Mobility: Timed up and go test(Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline)
- Health Related Quality of Life: EQ-5D(Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline)
- Falls efficacy: Nursing home falls self efficacy scale(Baseline, 3 months from baseline measures, 6 months from baseline, 9 months from baseline)
研究者
Gavin Wylie
Principle Investigator
NHS Tayside