Dane County Safety Assessment for Elders (SAFE) Research Study

Falls Clinical Trial

Official title:

Dane County Safety Assessment for Elders (SAFE) Research Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00205114
• Other study ID #: 2003-042
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: October 1, 2015
• Start date: December 2003
• Est. completion date: September 2006

Study information

• Verified date: December 2007
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Falls

Intervention

Behavioral:
• Individualized multifactorial intervention for community-living high-risk older adults

• Health professional education program about fall prevention

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of falls among high-risk older adults randomized to the individualized multifactorial intervention		over one year	No
Secondary	Rate of fall-related hospitalizations among older adults in the intervention		one year	No