Epidemiology and Cost of Falls in Veterans With a Spinal Cord Injury

NCT00119522 | Completed

• 1 other identifier: IIR 03-003
• Study Type: observational
• Target: 702
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Spinal Cord Injury

Keywords

wheelchairs; falls; spinal cord injury; accidental falls; safety

Outcome Measures

Primary Outcomes (1)

• tips and falls from wheelchairs

  one year

Study Arms (1)

Group 1

cohort is of individuals with a spinal cord injury who use a wheelchair as their primary means of mobility

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

spinal cord injury population

You may qualify if:

• Must be a veteran with a spinal cord injury and use a wheelchair as primary means of mobility.

You may not qualify if:

• 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.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (3)

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, 33612, United States

Location

Charlie Norwood VA Medical Center, Augusta, GA

Augusta, Georgia, 30904, United States

Location

VA Boston Healthcare System Brockton Campus, Brockton, MA

Brockton, Massachusetts, 02301, United States

Location

Related Publications (3)

• 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.

  PMID: 15839290 RESULT

• Gavin-Dreschnack D. Effects of wheelchair posture on patient safety. Rehabil Nurs. 2004 Nov-Dec;29(6):221-6.

  PMID: 15598002 RESULT

• 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.

  PMID: 20684896 RESULT

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Audrey L. Nelson, RN PhD FAAN

  James A. Haley Veterans' Hospital, Tampa, FL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2005
• First Posted: July 13, 2005
• Study Start: April 1, 2004
• Primary Completion: March 1, 2006
• Study Completion: March 1, 2008
• Last Updated: April 7, 2015

Record last verified: 2008-07

Locations

US (3)