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Sponsor study identifier
observational
702
1 country
3
Study Start
April 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2006
Actual (reported)Study Completion
March 2008
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2008
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2004
Date type not reportedThis date has not been verified as actual or estimated.
July 1, 2005
Actual (reported)July 13, 2005
Actual (reported)March 2006
Actual (reported)March 2008
Actual (reported)tips and falls from wheelchairs
one year
cohort is of individuals with a spinal cord injury who use a wheelchair as their primary means of mobility
spinal cord injury population
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, 33612, United States
Charlie Norwood VA Medical Center, Augusta, GA
Augusta, Georgia, 30904, United States
VA Boston Healthcare System Brockton Campus, Brockton, MA
Brockton, Massachusetts, 02301, United States
Gavin-Dreschnack D, Nelson A, Fitzgerald S, Harrow J, Sanchez-Anguiano A, Ahmed S, Powell-Cope G. Wheelchair-related falls: current evidence and directions for improved quality care. J Nurs Care Qual. 2005 Apr-Jun;20(2):119-27. doi: 10.1097/00001786-200504000-00006.
Gavin-Dreschnack D. Effects of wheelchair posture on patient safety. Rehabil Nurs. 2004 Nov-Dec;29(6):221-6.
Nelson AL, Groer S, Palacios P, Mitchell D, Sabharwal S, Kirby RL, Gavin-Dreschnack D, Powell-Cope G. Wheelchair-related falls in veterans with spinal cord injury residing in the community: a prospective cohort study. Arch Phys Med Rehabil. 2010 Aug;91(8):1166-73. doi: 10.1016/j.apmr.2010.05.008.
Audrey L. Nelson, RN PhD FAAN
James A. Haley Veterans' Hospital, Tampa, FL
702 participants (actual enrollment reported by the registry).
First Submitted
July 1, 2005
First Posted
July 13, 2005
Study Start
April 2004
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
March 2006
Actual (reported)Study Completion
March 2008
Actual (reported)Last Updated
April 7, 2015
Record last verified: 2008-07
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Source: ClinicalTrials.gov.
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