Dane County Safety Assessment for Elders (SAFE) Research Study
1 other identifier
interventional
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2003
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedOctober 5, 2015
December 1, 2007
2.8 years
September 13, 2005
October 1, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of falls among high-risk older adults randomized to the individualized multifactorial intervention
over one year
Secondary Outcomes (1)
Rate of fall-related hospitalizations among older adults in the intervention
one year
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Reside in a community-based residential facility (i.e. group home)
- Are unable to give informed consent and have no related, in-home caregiver
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Wisconsin
Madison, Wisconsin, 53792, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Jane E Mahoney, MD
University of Wisconsin, Madison
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 20, 2005
Study Start
December 1, 2003
Primary Completion
September 1, 2006
Study Completion
September 1, 2006
Last Updated
October 5, 2015
Record last verified: 2007-12