CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 702 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT00119522
NCT00119522N/ACompleted

Epidemiology and Cost of Falls in Veterans With Spinal Cord Injury

US Department of Veterans Affairs·observational·Posted Jul 13, 2005·Updated Apr 7, 2015

In Brief

An observational study for Spinal Cord Injury. Completed, enrolled 702 participants across 3 sites.

Detailed Summary

Brief Summary Detailed Description Background: A multitude of risk factors for falling has been reported for the elderly, however many of these risk factors are not applicable to persons with a spinal cord injury, who use a wheelchair for mobility. The objectives of this study are to: (1) describe the incidence and prevalence of tips, falls, and fall-related injuries in SCI; (2) describe the epidemiology of the fall event (person, time, place, and activity); (3) describe any injuries associated with a fall, including the mechanism and nature of the injury, severity of injury, as well as treatment required; (4) determine the risk factors related to falls and fall-related injuries in SCI, and develop a model for predicting falls and fall-related injuries in SCI; (5) determine healthcare utilization as well as direct and indirect costs associated with fall-related injuries in SCI; and (6) describe patient-perceived short- and long-term consequences of falls in SCI. The data collection for this study was completed on March 31, 2007, and data analysis is in final phase. Objectives: The objectives of the study are to describe: (1) the incidence and prevalence of wheelchair tips, falls, and fall-related injuries; (2) epidemiology of event; (3) injuries associated with event, including mechanism, nature, severity of injury and treatment required; (4) determine risk factors and develop a model for predicting tips and falls; (5) determine healthcare utilization and direct and indirect costs; and (6) describe perceived short- and long-term consequences of falls in SCI. Methods: This is a prospective cohort study. Data was collected through patient surveys, medical records, and VA databases. Baseline information includes risk factors (e.g., user characteristics, wheelchair features, wheelchair activities, etc.) and physical environmental data. Monthly follow-up calls tracked tips, falls, and injuries. Status: Recruitment ended on April 1, 2006 with a total of 702 subjects, and data collection was completed on March 31, 2007. The Data Safety Monitoring Board for this study conducted its final meeting on September 17, 2007. Data has been analyzed and 17 manuscripts are currently in development. Impact: While much is known about falls in elderly, there is a lack of understanding of the epidemiology of wheelchair-related falls. Our project is expected to identify previously unaccounted for factors that predispose persons with SCI to falls and fall-related injuries. This study will result in the creation of a model for predicting falls and fall-related injuries in SCI. The predictive model will be used to develop intervention strategies targeting modifiable risk factors. Eventually, we will test this predictive model with other vulnerable veteran populations. Findings from this study wil be used to develop an instrument to identify fall risk in persons with SCI.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 13, 2005
Enrollment StartApr 1, 2004
Primary CompletionMar 1, 2006
Study CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 21.0 years ago