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临床试验/NCT00817869
NCT00817869已完成不适用

Pilot Cluster Randomised Controlled Trial of Flooring to Reduce Injuries From Falls in Elderly Care Units

University of Portsmouth8 个研究点 分布在 1 个国家目标入组 571 人开始时间: 2010年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
571
试验地点
8
主要终点
fall-related injury

研究概览

简要总结

In hospitals, older people can fall and hurt themselves. The investigators want to see if a new type of flooring can help stop people hurting themselves as badly, if they accidentally fall.

详细描述

We will carry out the study in eight elderly care wards across England. We will first study the wards for up to 6 months. Then, half of the wards will have the new floor laid. Wards will be chosen to receive the new floor, or remain with a standard floor, by chance. The new floor has 'shock-absorbent' properties. We will study all the wards for another 12 months. This will allow us to compare the new flooring with the normal flooring.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •all patients admitted to the study area on a participating elderly care ward

排除标准

  • 未提供

研究组 & 干预措施

New Flooring

Experimental

Will receive 8.3mm thick floor covering (Omnisports EXCEL) to replace previous floor covering.

干预措施: New flooring (Other)

Standard Flooring

No Intervention

Ward will remain with standard floor covering. The overlay will have a comparable slip resistance rating to the new flooring. The sub-floor will also be comparable.

结局指标

主要结局

fall-related injury

时间窗: Study duration = 18 months. Outcome measured for each patient for duration of stay in ward (approx. 30 days).

次要结局

  • Number of falls(Study duration = 18 months. Outcome measured for each patient for duration of stay in ward (approx. 30 days).)
  • Slip resistance of flooring(Measured at 4 time-points over 1.5 years (1 month; 6 months; 12 months; 18 months))
  • Place of residence (for cost-effectiveness analysis)(Each patient followed-up 3 months post-discharge)
  • Quality of life (for cost-effectiveness analysis)(Each patient followed-up 3 months post-discharge)
  • Unexpected adverse events(Study duration = 18 months. Outcome measured for each patient for duration of stay in ward (approx. 30 days).)
  • Number of hospital re-admissions (for cost-effectiveness analysis)(Each patient followed-up 3 months post-discharge)
  • Shock-absorbency of flooring(Measured at 4 time-points over 1.5 years (1 month; 6 months; 12 months; 18 months))
  • User views (patients and staff)(Collected during 1 year follow-up of intervention sites (months 6 to 18))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Martin Severs

Professor

University of Portsmouth

研究点 (8)

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