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临床试验/NCT00350389
NCT00350389已完成不适用

Randomised Controlled Falls Prevention Trial of Plain Distance Glasses in Elderly Multifocal Wearers.

The University of New South Wales2 个研究点 分布在 1 个国家目标入组 606 人开始时间: 2005年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
606
试验地点
2
主要终点
Falls rates, Falls diaries

研究概览

简要总结

The purpose of this study is to determine whether the provision of supplementary plain distance glasses for outdoor use to older users multifocal glasses will reduce falls rates over a 12 month period.

详细描述

Background: Bi-, tri- and multi- focal ('multifocal') glasses have been associated with increased rates of falls in older people (Lord et al 2002).

Study Aim: To determine whether the provision of supplementary plain distance glasses for outdoor use to older users multifocal glasses will reduce falls rates over a 12 month period.

Study Design: A randomised controlled assessor-blinded trial with two parallel groups in 580 participants. Study inclusion criteria are: outdoor use of multifocal glasses 3 or more times per week, community-dwelling persons aged 65+ years with a recent fall OR persons aged 80+ years regardless of falls history, Folstein Mini Mental score of 24+, and adequate visual contrast sensitivity (Melbourne Edge Test score of 16+dB). All participants will receive an optometry assessment and updated multifocal glasses (if required) at baseline. Intervention group subjects will receive a pair of plain distance glasses and counselling for their use in predominantly outdoor situations. Control group participants will use their multifocal glasses in their usual manner. Falls rates and compliance with the intervention will be recorded on monthly falls diaries returned by the participants.

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
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

入选标准

  • outdoor use of multifocal glasses 3 or more times per week
  • community-dwelling persons aged 65+ years with a recent fall OR persons aged 80+ years regardless of falls history
  • Folstein Mini Mental score of 24+
  • adequate visual contrast sensitivity (Melbourne Edge Test score of 16+dB)

排除标准

  • nursing home residents

结局指标

主要结局

Falls rates, Falls diaries

时间窗: 12 months

次要结局

  • Modified Falls Efficacy Scale(12 months)
  • Quality of life, SF-36(12 months)
  • Instrumental Activities of Daily Living, Adelaide Activities Profile(12 months)

研究者

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

Stephen Lord

Senior Principal Research Fellow

The University of New South Wales

研究点 (2)

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