Spinal Cord Injury Clinical Trial
Official title:
Epidemiology and Cost of Falls in Veterans With Spinal Cord Injury
Verified date | July 2008 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Observational |
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.
Status | Completed |
Enrollment | 702 |
Est. completion date | March 2008 |
Est. primary completion date | March 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Must be a veteran with a spinal cord injury and use a wheelchair as primary means of mobility. Exclusion Criteria: Spinal cord injury less than 2 years. Use of mobility device other than wheelchair as primary means of mobility. Incomplete injury that does not warrant use of a wheelchair. Ventilator dependent. On bedrest for more than 30 days. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Charlie Norwood VA Medical Center, Augusta, GA | Augusta | Georgia |
United States | VA Boston Healthcare System Brockton Campus, Brockton, MA | Brockton | Massachusetts |
United States | James A. Haley Veterans' Hospital, Tampa, FL | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
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. Review. — View Citation
Gavin-Dreschnack D. Effects of wheelchair posture on patient safety. Rehabil Nurs. 2004 Nov-Dec;29(6):221-6. Review. — View Citation
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) — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | tips and falls from wheelchairs | one year | No |
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