Dane County Safety Assessment (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: NCT00140322
• Other study ID #: CDC-NCIPC-3954
• Secondary ID: U17/CCU522465
• Status: Completed
• Phase: N/A
• First received: August 30, 2005
• Last updated: February 2, 2016
• Start date: October 2002
• Est. completion date: August 2005

Study information

• Verified date: February 2016
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

A randomized controlled trial to assess the effectiveness of an at-home comprehensive approach to preventing falls among adults 65 years and older at high risk for falls.

Description:

A randomized controlled trial to assess the effectiveness of a comprehensive approach to preventing falls among adults 65 years and older at high risk for falls. This intervention includes a comprehensive health assessment in each participant's home combined with tailored risk reduction strategies such as individualized strength and balance exercises. The study is also conducting a community-based program to engage and educate physicians about fall prevention.

The goal of the study is to demonstrate a 40% decrease in fall rates. Other expected outcomes include decreased hospital and nursing home stays, improved physical function, and a decreased fear of falling.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 455
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria: Adults age 65+, at high risk for falls, -

Exclusion Criteria: Adults <65 years

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Falls

Intervention

Behavioral:
• Exercise, fall risk reduction

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	University of Wisconsin, Madison, Wisconsin Department of Health and Family Services

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decreased fall rates
Secondary	decreased hospital and nursing home stays
Secondary	improved physical function
Secondary	decreased fear of falling