Trial Outcomes & Findings for Characterizing Wheelchair-Related Falls in Elderly Veterans (NCT NCT00363246)

NCT ID: NCT00363246

Last Updated: 2015-07-29

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 766 participants
• Primary outcome timeframe: one year follow-up period
• Results posted on: 2015-07-29

Participant Flow

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.

Participant milestones

Measure	Group 1 Older veterans who use a wheelchair for their primary means of mobility.
Overall Study STARTED	766
Overall Study COMPLETED	669
Overall Study NOT COMPLETED	97

Reasons for withdrawal

Measure	Group 1 Older veterans who use a wheelchair for their primary means of mobility.
Overall Study Death	40
Overall Study Withdrawal by Subject	19
Overall Study Lost to Follow-up	14
Overall Study Bad health	6
Overall Study Stopped using wheelchair	11
Overall Study Subject expressed security concerns	2
Overall Study Eligibility changed due to Hospice move	5

Baseline Characteristics

Characterizing Wheelchair-Related Falls in Elderly Veterans

Baseline characteristics by cohort

Measure	Group 1 n=766 Participants Older veterans who use a wheelchair for their primary means of mobility.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	92 Participants n=5 Participants
Age, Categorical >=65 years	674 Participants n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	738 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	231 participants n=5 Participants
Race/Ethnicity, Customized American Indian	1 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	40 participants n=5 Participants
Race/Ethnicity, Customized White	492 participants n=5 Participants
Race/Ethnicity, Customized Unknown or Not Reported	2 participants n=5 Participants
Region of Enrollment United States	766 participants n=5 Participants
Health Excellent/Very Good/Good	283 participants n=5 Participants
Health Fair/Poor	427 participants n=5 Participants
Health Insufficient data to analyze	56 participants n=5 Participants
Pain in last 4 weeks (interference with daily activities) None/Mild	210 participants n=5 Participants
Pain in last 4 weeks (interference with daily activities) Moderate/Severe	499 participants n=5 Participants
Pain in last 4 weeks (interference with daily activities) Missing	1 participants n=5 Participants
Pain in last 4 weeks (interference with daily activities) Insufficient data to analyze	56 participants n=5 Participants
Pain when transfer Mild	315 participants n=5 Participants
Pain when transfer Moderate	180 participants n=5 Participants
Pain when transfer Severe	213 participants n=5 Participants
Pain when transfer Missing	2 participants n=5 Participants
Pain when transfer Insufficient data to analyze	56 participants n=5 Participants
Energy levels	11.9 units on a scale STANDARD_DEVIATION 4.5 • n=5 Participants

PRIMARY outcome

Timeframe: one year follow-up period

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

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

Outcome measures

Measure	Wheelchair-using Veterans n=710 Participants Older veterans who use a wheelchair for their primary means of mobility. 1 year follow-up period.
Wheelchair-related Falls No Wheelchair-related Fall	545 participants
Wheelchair-related Falls Wheelchair-related Fall	165 participants

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Wheelchair-using Veterans n=710 Participants Older veterans who use a wheelchair for their primary means of mobility. 1 year follow-up period.
Injuries From Wheelchair-related Falls No Wheelchair-related fall injuries	607 participants
Injuries From Wheelchair-related Falls Wheelchair-related fall injuries	103 participants

Adverse Events

Elderly Veterans Using Wheelchairs for Mobility

Serious events: 40 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure

Elderly Veterans Using Wheelchairs for Mobility n=762 participants at risk Older veterans who use a wheelchair for their primary means of mobility. This was an observational study. There was no intervention and thus no adverse events were collected as part of the study. Sometimes we learned of a death from a relative when we called monthly.

General disorders Death

5.2% 40/762 • The original study (PI: Dr. Nelson, Co-PI: Dr. Groer) was approved by the affiliate University of South Florida Institutional Review Board (IRB) on 06/09/2006. Subject recruitment ended November 30, 2008. Data collection ended in December 2009. This was a non-interventional, observational study of elderly veterans who regularly used a wheelchair for mobility. Adverse events other than death were not collected. Sometimes we were told of a death by a relative when we called. Any serious adverse events were unrelated to the study, which did not involve an intervention.

Other adverse events

Adverse event data not reported

Additional Information

Andrea M. Spehar, DVM, MPH, JD

James A. Haley Veterans' Hospital

Phone: 813-558-3947

Email: Andrea.Spehar@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place