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临床试验/NCT00205114
NCT00205114已完成不适用

Dane County Safety Assessment for Elders (SAFE) Research Study

University of Wisconsin, Madison2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2003年12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
500
试验地点
2
主要终点
Rate of falls among high-risk older adults randomized to the individualized multifactorial intervention

研究概览

简要总结

This 3-year collaborative project will develop, implement, and test a comprehensive approach to the prevention of falls among high-risk older adults in Dane County, Wisconsin through two complementary strategies:

  1. a targeted strategy of an individualized multifactorial intervention for community-living high-risk older adults. Older adults are defined as aged 65 and older. High risk is defined as two or more falls in the year prior, one fall with injury, or one fall with gait and balance problems, as per recent guidelines from the American Geriatric Society (AGS). The multifactorial intervention consists of an in-home assessment followed by recommendations to the participant and his/her physician, a prescription for physical therapy, other referrals (optometry, podiatry, occupational therapy, etc.) based on the assessment, monthly phone follow-up for 11 months, and a prescription for long-term exercise after physical therapy.
  2. a program to educate primary care physicians, physician assistants, nurse practitioners, and physical therapists in Dane County in the current diagnosis and treatment recommendations for fall prevention.

详细描述

The purposes of the project are:

  1. To test, in a randomized, controlled, single-blind study design, whether a multifactorial intervention for high-risk older adults will decrease the rate of falls compared to a control group receiving a home safety and nutrition booklet by mail;
  2. To enhance existing health professional knowledge base to support fall prevention;
  3. To test, in a quasi-experimental study design, the ability of a community-wide health professional educational program to decrease the rate of fall-related hospitalizations among older adults (both high and low-risk) in Dane County compared to control counties in Wisconsin.

We hypothesize that:

The rate of falls will be 40% lower over one year among high-risk older adults randomized to the individualized multifactorial intervention (combined with health professional education), compared to those randomized to home safety and nutrition booklets (combined with health professional education) in Dane County.

A health professional education program about fall prevention will decrease the rate of fall-related hospitalizations among older adults (both high and low-risk) in the intervention county by 10%, compared to an anticipated no change from baseline in control counties.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
盲法
Single (Investigator)

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

  • Community-residing in Dane County or surrounding communities.
  • Seniors living in assisted-living senior apartments
  • Aged 65 and older
  • At high risk for falls as defined by AGS criteria (two or more falls in the past year, or one fall with injury, or one fall with abnormal gait or balance)

排除标准

  • Reside in a community-based residential facility (i.e. group home)
  • Are unable to give informed consent and have no related, in-home caregiver

结局指标

主要结局

Rate of falls among high-risk older adults randomized to the individualized multifactorial intervention

时间窗: over one year

次要结局

  • Rate of fall-related hospitalizations among older adults in the intervention(one year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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