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Characterizing Wheelchair-Related Falls in Elderly Veterans

Characterizing Wheelchair-Related Falls in Elderly Veterans

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00363246
Enrollment
766
Registered
2006-08-15
Start date
2007-06-30
Completion date
2012-12-31
Last updated
2015-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Accidental Falls

Keywords

Elderly, Fall risk, Veterans, WheelChairs, Injury

Brief summary

The purpose of this study is to find out about the risk factors for wheelchair-related falls among elderly veterans, and to find out about the costs and consequences of those falls.

Detailed description

Rationale and Objectives. A multitude of risk factors for falls has been reported, however many of these risk factors are not applicable to persons who use a wheelchair for mobility. Specific objectives include: (1) Describe the incidence and prevalence of wheelchair tips (near falls), falls, and fall-related injuries, (2) Describe the epidemiology of the wheelchair tip or fall event. (3) Create models for predicting wheelchair tips, falls, and fall-related injuries for elderly persons who use a wheelchair for mobility. (4) Determine healthcare utilization and direct costs associated with wheelchair-related fall injuries. (5) Describe patient perceived short- and long-term consequences of wheelchair-related falls. Research Design. This 3-year prospective cohort study includes qualitative and quantitative data collected at baseline data and through monthly follow-up phone interviews over a 12-month period. Data Source. Baseline data on demographics, intrinsic risk factors, and extrinsic risk factors will be collected through interviews. We will assess functional status, cognition, and home management skills through standardized tools. Administrative databases will be used to gather data regarding comorbidities, Veterans Health Administration (VHA) health care utilization and direct costs. A physical therapy assistant will also conduct a wheelchair inventory and wheelchair skills test. Monthly follow-up phone interviews will include number of falls, description of the fall event/mechanism and nature of the injury, changes in modifiable risk factors, and description of injury and treatment. A separate phone interview will be conducted with a subset of subjects at 6 months post fall, using open-ended questions to gather data about patient-perceived long-term consequences of falls. At the end of the 12-month data collection, we will reassess patient's functional status and cognition. Sample. Inclusion criterion includes all veterans who (1) are aged 62 and older, (2) use a wheelchair for their primary means of mobility, (3) have used a wheelchair for at least 12 months previous to enrollment, and (4) will be using a wheelchair for at least the next 12 months. Exclusion criteria (1) no longer living in a community-based setting (e.g., admitted to nursing home), (2) do not have a telephone. We will over sample women and minorities. A total of 882 subjects are needed for a power of 0.8 and an alpha of 0.05 with an anticipated drop out rate of 30%. Analysis. Bivariate analysis will be performed to determine relationships between outcomes and risk factors. Logistic regression models for predicting wheelchair-related tips, falls and fall-related injuries will be developed based on the most important intrinsic and extrinsic risk factors, controlling for possible confounders. Falls will also be analyzed according to a survival-analysis technique. Univariate and multiple Cox regression will be used to assess the associations of different independent variables with the injurious fall. The cost analysis estimates the net or marginal costs of wheelchair users who experience a wheelchair fall accident and seek medical advice or treatment. We use a dichotomous fall (generating medical expense) variable for a with or without analysis to compare the average cost of medical care for wheelchair users without a fall involving medical observation or care to the average cost of those that did have a serious fall (including death). The difference between these two groups is a proxy of the cost of utilization due to the fall. Multivariate regression analysis will be used to gauge the net effects of a fall on costs, controlling for the wider array of factors that drive cost of treatment and thereby potentially confound univariate analysis. The control variables are demographic including co-morbid conditions and healthcare related. Anticipated Impact. Our project is expected to identify previously unaccounted for factors that predispose persons who use a wheelchair to falls and fall-related injuries. We will create models for predicting wheelchair tips, falls, and fall-related injuries. These models will be used to develop an evidence-based, patient centered wheelchair falls prevention program targeting modifiable risk factors. Findings from this study will be so used to develop an instrument to identify fall risk in elderly wheelchair users as well as an evidenced-based prevention program. We will partner with the VA National Center for Patient Safety to disseminate these products nationally in the VHA.

Interventions

None listed

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
62 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* veteran * aged 62 and older * use a wheelchair for their primary means of mobility * have used a wheelchair for at least 12 months previous to enrollment * will be using a wheelchair for at least the next 12 months

Exclusion criteria

* not living in a community-based setting * no access to a telephone

Design outcomes

Primary

MeasureTime frameDescription
Wheelchair-related Fallsone year follow-up periodWheelchair-related falls in 1 year follow-up period.

Secondary

MeasureTime frameDescription
Injuries From Wheelchair-related Fallsone year follow-up periodWheelchair-related falls that resulted in an injury in the one year follow up period

Countries

Puerto Rico, United States

Participant flow

Recruitment details

Recruitment began 06/01/2007; recruitment ended 11/30/2008. Data collection ended in December 2009. Subjects were approached in a VA medical clinic and given list of qualifying criteria on our flyer. After consent, a Mini-Mental State Examination (MMSE) is administered to all potential subjects; a score of at least 24 is required to participate.

Participants by arm

ArmCount
Group 1
Older veterans who use a wheelchair for their primary means of mobility.
766
Total766

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyBad health6
Overall StudyDeath40
Overall StudyEligibility changed due to Hospice move5
Overall StudyLost to Follow-up14
Overall StudyStopped using wheelchair11
Overall StudySubject expressed security concerns2
Overall StudyWithdrawal by Subject19

Baseline characteristics

CharacteristicGroup 1
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
674 Participants
Age, Categorical
Between 18 and 65 years
92 Participants
Energy levels11.9 units on a scale
STANDARD_DEVIATION 4.5
Health
Excellent/Very Good/Good
283 participants
Health
Fair/Poor
427 participants
Health
Insufficient data to analyze
56 participants
Pain in last 4 weeks (interference with daily activities)
Insufficient data to analyze
56 participants
Pain in last 4 weeks (interference with daily activities)
Missing
1 participants
Pain in last 4 weeks (interference with daily activities)
Moderate/Severe
499 participants
Pain in last 4 weeks (interference with daily activities)
None/Mild
210 participants
Pain when transfer
Insufficient data to analyze
56 participants
Pain when transfer
Mild
315 participants
Pain when transfer
Missing
2 participants
Pain when transfer
Moderate
180 participants
Pain when transfer
Severe
213 participants
Race/Ethnicity, Customized
American Indian
1 participants
Race/Ethnicity, Customized
Black or African American
40 participants
Race/Ethnicity, Customized
Hispanic
231 participants
Race/Ethnicity, Customized
Unknown or Not Reported
2 participants
Race/Ethnicity, Customized
White
492 participants
Region of Enrollment
United States
766 participants
Sex: Female, Male
Female
28 Participants
Sex: Female, Male
Male
738 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
40 / 762

Outcome results

Primary

Wheelchair-related Falls

Wheelchair-related falls in 1 year follow-up period.

Time frame: one year follow-up period

Population: Older veterans who use a wheelchair for their primary means of mobility.

ArmMeasureGroupValue (NUMBER)
Wheelchair-using VeteransWheelchair-related FallsNo Wheelchair-related Fall545 participants
Wheelchair-using VeteransWheelchair-related FallsWheelchair-related Fall165 participants
Comparison: Health Status. No Wheelchair-related Falls vs. Wheelchair-related Falls.p-value: 0.033Chi-squared
Comparison: Pain in last 4 weeks (interference with daily activities). No Wheelchair-related Falls vs. Wheelchair-related Falls.p-value: 0.013Chi-squared
Comparison: Pain when transfer. No Wheelchair-related Falls vs. Wheelchair-related Falls.p-value: <0.001Chi-squared
Comparison: Energy level. No Wheelchair-related Falls vs. Wheelchair-related Falls.p-value: 0.007t-test, 2 sided
Secondary

Injuries From Wheelchair-related Falls

Wheelchair-related falls that resulted in an injury in the one year follow up period

Time frame: one year follow-up period

Population: Older veterans who use a wheelchair for their primary means of mobility. Analyzed for wheelchair-related fall injury during 1-year follow-up period.

ArmMeasureGroupValue (NUMBER)
Wheelchair-using VeteransInjuries From Wheelchair-related FallsNo Wheelchair-related fall injuries607 participants
Wheelchair-using VeteransInjuries From Wheelchair-related FallsWheelchair-related fall injuries103 participants
Comparison: Health Status. No Wheelchair-related Fall Injuries vs. Wheelchair-related Fall Injuries.p-value: 0.049Chi-squared
Comparison: Pain in last 4 weeks (interference with daily activities). No Wheelchair-related Fall Injuries vs. Wheelchair-related Fall Injuries.p-value: 0.013Chi-squared
Comparison: Pain when transfer. No Wheelchair-related Fall Injuries vs. Wheelchair-related Fall Injuries.p-value: 0.0001Chi-squared
Comparison: Energy level. No Wheelchair-related Fall Injuries vs. Wheelchair-related Fall Injuries.p-value: 0.009t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026