NCT00554437

Brief Summary

Intensive falls prevention programs have been shown to be effective in reducing falls; however, a number of practical programs, based in community setting have not been successful at reducing rate of falls. The purpose of this study was to test, in a randomized, controlled trial, the efficacy of this intermediate-intensity, individual, multifactorial model to reduce falls. It was hypothesized that more contacts would lead to greater adherence and efficacy in reducing falls.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
349

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2002

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

November 2, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 6, 2007

Completed
Last Updated

July 14, 2023

Status Verified

November 1, 2008

First QC Date

November 2, 2007

Last Update Submit

July 12, 2023

Conditions

Keywords

Accidental FallsRCTAge 65 and oldernoninstitualized populations

Outcome Measures

Primary Outcomes (1)

  • rate of falls

    one year

Secondary Outcomes (3)

  • all-cause hospitalizations

    one year

  • nursing home utilizations: number of days and number of admissions

    one year

  • change in ADL function from baseline to one year

    one year

Study Arms (2)

1

EXPERIMENTAL

Intermediate-intensity, community-based, multifactorial falls intervention

Behavioral: UW Falls Prevention Program

2

ACTIVE COMPARATOR

Occupational therapist home safety evaluation

Behavioral: UW Falls Prevention Program

Interventions

The intervention model is of a community-based multifactorial intervention that links participants to existing medical care and service networks. The intervention used an algorithm based on the University of Wisconsin Falls Prevention Clinic, designed to identify predisposing factors for falls; induce risk reduction changes in medical conditions, medications, behavior, physical status, and home environment through recommendations to participants and their physicians; and make sure these changes are long-lasting through follow-up and linkages to other care networks.

12

Eligibility Criteria

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

You may qualify if:

  • aged 65 and older
  • a history of two falls in the previous year or one fall in the previous two years with injury or gait and balance problems
  • independently living in Kenosha County

You may not qualify if:

  • unable to give informed consent with no related caregiver in the home
  • enrolled in hospice
  • living in an assisted-living facility
  • expecting to move away permanently from the area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Mahoney JE, Shea TA, Przybelski R, Jaros L, Gangnon R, Cech S, Schwalbe A. Kenosha County falls prevention study: a randomized, controlled trial of an intermediate-intensity, community-based multifactorial falls intervention. J Am Geriatr Soc. 2007 Apr;55(4):489-98. doi: 10.1111/j.1532-5415.2007.01144.x.

Study Officials

  • Jane E Mahoney, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2007

First Posted

November 6, 2007

Study Start

May 1, 2002

Study Completion

June 1, 2004

Last Updated

July 14, 2023

Record last verified: 2008-11