Dane County Safety Assessment for Elders (SAFE) Research Study - Full Text View

Sponsored by:	University of Wisconsin, Madison
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00205114

Purpose

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:

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.
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	Intervention
Falls	Behavioral: Individualized multifactorial intervention for community-living high-risk older adults Behavioral: Health professional education program about fall prevention

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Single Blind (Investigator), Active Control, Single Group Assignment
Official Title:	Dane County Safety Assessment for Elders (SAFE) Research Study

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:

Rate of falls among high-risk older adults randomized to the individualized multifactorial intervention [ Time Frame: over one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Rate of fall-related hospitalizations among older adults in the intervention [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment:	500
Study Start Date:	December 2003
Study Completion Date:	September 2006
Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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 ( Jane E. Mahoney, M.D. )
Study ID Numbers:	2003-042
Study First Received:	September 13, 2005
Last Updated:	December 26, 2007
ClinicalTrials.gov Identifier:	NCT00205114
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on January 16, 2009