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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00119522
First received: July 1, 2005
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

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.


Condition
Spinal Cord Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epidemiology and Cost of Falls in Veterans With Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • tips and falls from wheelchairs [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 702
Study Start Date: April 2004
Study Completion Date: March 2008
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1
cohort is of individuals with a spinal cord injury who use a wheelchair as their primary means of mobility

Detailed Description:

Of the 702 patients enrolled, 659 subjects provided data for follow up analysis. The primarily male (96%) population was 55 + 13 years old, and had their SCI for an average of 21 + 13 years. 47% of the injury levels were cervical and 46% thoracic. The majority of subjects used manual wheelchairs (62%) an average of 10.9 + 4.3 hours a day. 553 fall events were reported by 204 individuals. 95 (14%) subjects were injured as a result of the fall. Regression models showed that fall occurrence was predicted by increased pain in past two months, increased alcohol use, higher FIM sub-motor scores, having a previous fall, shorter wheelchair length, fewer years of SCI, and not having one's first wheelchair. Injurious falls were predicted by increased pain in past two months, higher FIM sub-motor scores, having a previous fall, non-flat home entrance and a diagnosis of arthritis. In both models, 83% of the variance was explained by the predictors. Additional analysis is planned for completion of manuscripts. In addition, funding was received to develop a risk assessment tool for falls from wheelchairs in SCI.

Final analyses are being conducted and 17 manuscripts are currently in development.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

spinal cord injury population

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00119522

Locations
United States, Florida
James A. Haley VA Hospital
Tampa, Florida, United States, 33637-1022
United States, Georgia
VA Medical Center, Augusta
Augusta, Georgia, United States, 30904-6285
United States, Massachusetts
VA Boston Healthcare System, Brockton
Brockton, Massachusetts, United States, 02301
Sponsors and Collaborators
Investigators
Principal Investigator: Audrey L. Nelson, RN PhD FAAN James A. Haley VA Hospital
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00119522     History of Changes
Other Study ID Numbers: IIR 03-003
Study First Received: July 1, 2005
Last Updated: April 15, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
wheelchairs
falls
spinal cord injury
accidental falls
safety

Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 23, 2014