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Completed

NCT Number: NCT00205114

Dane County Safety Assessment for Elders (SAFE) Research Study

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.

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Key information

Conditions

Falls

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin

Madison, Wisconsin, 53792, United States

About this study

The purposes of the project are:

  • 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;
  • To enhance existing health professional knowledge base to support fall prevention;
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

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

Treatment and study plan

Individualized multifactorial intervention for community-living high-risk older adults

Behavioral

Health professional education program about fall prevention

Behavioral

Primary outcomes

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

    Time frame: over one year

Secondary outcomes

  1. Rate of fall-related hospitalizations among older adults in the intervention

    Time frame: one year

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Sep 20, 2005
Registry last updated
Oct 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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