NCT00590746

Brief Summary

The purpose of this study is to assess the risk for falls among elderly Emergency Department (ED) patients.This study will use 2 tests of balance, the Bertec Balance Screening Test and the "Up and Go" test. These tests measure how steady a person is while standing, walking, and turning 180 degrees. After patients have returned home, they will be contacted at 7 days, 30 days and 6 months to determine if they have sustained a fall during these intervals in order to find out how predictive the balance tests are in determining the risk of future falls.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2007

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, 2007

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 11, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

February 13, 2014

Status Verified

February 1, 2014

Enrollment Period

10 months

First QC Date

December 26, 2007

Last Update Submit

February 11, 2014

Conditions

Outcome Measures

Primary Outcomes (2)

  • To determine the accuracy of the timed Timed Up-and-go test in the ED

    1 year

  • To determine the accuracy of the Bertec BalanceCheck Screener system in the ED.

    1 year

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 60 and older who present to the Ohio State University Medical Center Emergency Department

You may qualify if:

  • Age \> 59 years
  • Discharge from Emergency Department
  • Self-reported weight \< 300 pounds
  • Patient resides in the community or a personal care home
  • Patients must also confirm that they are able to walk 30 feet without help of another person.They may do this with use of an assistive device.

You may not qualify if:

  • Age \<60 years
  • Subject is incarcerated
  • Non-English speaking
  • Lack of ability of patient to give consent or complete the study tasks
  • Patient resides in a nursing home or rehabilitation facility
  • Primary evaluation by the trauma team
  • Inability to walk 30 feet without assistance from another person

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Medical Center Emergency Department

Columbus, Ohio, 43210, United States

Location

Study Officials

  • Jeffrey M Caterino, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 26, 2007

First Posted

January 11, 2008

Study Start

December 1, 2007

Primary Completion

October 1, 2008

Study Completion

September 1, 2009

Last Updated

February 13, 2014

Record last verified: 2014-02

Locations