NCT00205114

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. 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. 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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2003

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

October 5, 2015

Status Verified

December 1, 2007

Enrollment Period

2.8 years

First QC Date

September 13, 2005

Last Update Submit

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

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

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

Location

Study Officials

  • Jane E Mahoney, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

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

Locations