Dane County Safety Assessment for Elders (SAFE) Research Study
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|ClinicalTrials.gov Identifier: NCT00205114|
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : October 5, 2015
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 or disease||Intervention/treatment||Phase|
|Falls||Behavioral: Individualized multifactorial intervention for community-living high-risk older adults Behavioral: Health professional education program about fall prevention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Dane County Safety Assessment for Elders (SAFE) Research Study|
|Study Start Date :||December 2003|
|Actual Primary Completion Date :||September 2006|
|Actual Study Completion Date :||September 2006|
- Rate of falls among high-risk older adults randomized to the individualized multifactorial intervention [ Time Frame: over one year ]
- Rate of fall-related hospitalizations among older adults in the intervention [ Time Frame: one year ]
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
|United States, Wisconsin|
|University of Wisconsin|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Jane E Mahoney, MD||University of Wisconsin, Madison|