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Dane County Safety Assessment for Elders (SAFE) Research Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00205114
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : October 5, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.

Condition or disease Intervention/treatment
Falls Behavioral: Individualized multifactorial intervention for community-living high-risk older adults Behavioral: Health professional education program about fall prevention

Detailed Description:

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Official Title: Dane County Safety Assessment for Elders (SAFE) Research Study
Study Start Date : December 2003
Primary Completion Date : September 2006
Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Rate of falls among high-risk older adults randomized to the individualized multifactorial intervention [ Time Frame: over one year ]

Secondary Outcome Measures :
  1. Rate of fall-related hospitalizations among older adults in the intervention [ Time Frame: one year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00205114


Locations
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Jane E Mahoney, MD University of Wisconsin, Madison
More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00205114     History of Changes
Other Study ID Numbers: 2003-042
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: October 5, 2015
Last Verified: December 2007