NCT01236170

Brief Summary

The Department of Veterans Affairs (VA) provides wheelchairs to about 42,000 Veterans with SCI and more than 40,000 Veterans with amputated limbs (AL). Despite VA's efforts to remove financial and other barriers to the provision of wheelchairs to all Veterans who need them, preliminary evidence suggests that disparities exist in the quality of wheelchairs prescribed to racial minorities and low income Veterans with SCI or AL. The proposed project will provide important information to the VA about the quality and equity of wheelchairs provided to Veterans with SCI or AL, and it will identify the patient and provider factors associated with wheelchair provision. Because Veterans with SCI and AL are considered special disability populations, identifying and understanding these factors is a critical first step to developing interventions to increase the quality and equity of wheelchairs provided to all disabled Veterans.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
497

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2011

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 8, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

December 31, 2014

Completed
Last Updated

June 27, 2019

Status Verified

June 1, 2019

Enrollment Period

2.4 years

First QC Date

November 4, 2010

Results QC Date

December 3, 2014

Last Update Submit

June 21, 2019

Conditions

Keywords

Amputeesspinal cord injuriesquality of lifesatisfactionhealthcare disparitieswheelchairs

Outcome Measures

Primary Outcomes (1)

  • Quality of Life Assessed With the Veterans RAND 12 Item Health Survey (VR-12)

    The investigators will assess QOL with the Veterans RAND 12 Item Health Survey (VR-12) and two additional physical function items designed for patients with SCI. Eight QOL domains are assessed, including physical functioning, vitality, role limitations due to physical problems, role limitations due to emotional problems, bodily pain, general health, social functioning, and mental health. The VR-12 has been used extensively with Veterans in a variety of health domains and has shown to be reliable and valid in ambulatory care populations (Cronbach's alpha= .83-.85). The additional two items were added because previous research demonstrated that existing measures of physical function in the VR12 are not appropriate to patients with SCI and are not able to reveal differences in physical function among SCI patients. The investigators assessed physical QOL and mental QOL, both scales range from 0 (worst possible outcome) to 100 (best possible outcome).

    Measured at baseline

Secondary Outcomes (4)

  • Satisfaction With Wheelchair Service Delivery

    one time use, at baseline

  • Satisfaction With Prescribed Wheelchair

    one time use, at baseline

  • Participation in Society

    Measured at baseline

  • Wheelchair Activity

    over a two week period following baseline

Study Arms (1)

Group 1

Veterans with spinal cord injury or amputated limbs who use a wheelchair as their primary source of mobility

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants will be recruited from the following four VA Medical Centers: the Philadelphia VA Medical Center in Philadelphia, PA; the Louis Stokes VA Medical Center in Cleveland, OH; The Hunter Holmes McGuire VA Medical Center in Richmond, VA; and the James J. Peters VA Medical Center in Bronx, NY. Recruitment will occur at SCI clinics, amputee clinics, wheelchair clinics, and patient registries.

You may qualify if:

  • Veterans
  • age \>18 years
  • must have SCI with discernible neurological impairments or an amputated lower limb which results in the use of a wheelchair
  • must be in power or manual wheelchair \>1 year and treated at the participating VAMC
  • participants must use a manual or power wheelchair as their primary means of mobility (e.g., use wheelchair \> 40 hours/week
  • and be non-ambulatory except for exercise purposes

You may not qualify if:

  • In wheelchair less than 1 year
  • Able to ambulate without the use of a wheelchair
  • Other disorders requiring the use of a wheelchair (e.g., MS)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, 33612, United States

Location

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468, United States

Location

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106, United States

Location

Center for Health Equity Research and Promotion

Pittsburgh, Pennsylvania, 15206, United States

Location

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Richmond, Virginia, 23249, United States

Location

Related Publications (3)

  • Hart-Hughes S, Highsmith MJ, Phillips SL, Groer S. A review of clinical outcome assessment instruments for gait, balance, and fall rish in persons with lower level extremity amputation. Topics in Geriatric Rehabilitation. 2014 Mar 31; 30(1):70-76.

    RESULT
  • Myaskovsky L, Gao S, Hausmann LRM, Bornemann KR, Burkitt KH, Switzer GE, Fine MJ, Phillips SL, Gater D, Spungen AM, Boninger ML. How Are Race, Cultural, and Psychosocial Factors Associated With Outcomes in Veterans With Spinal Cord Injury? Arch Phys Med Rehabil. 2017 Sep;98(9):1812-1820.e3. doi: 10.1016/j.apmr.2016.12.015. Epub 2017 Jan 25.

  • Myaskovsky L, Gao S, Hausmann LRM, Bornemann KR, Burkitt KH, Switzer GE, Fine MJ, Phillips SL, Gater D, Spungen AM, Worobey L, Boninger ML. Quality and Equity in Wheelchairs Used by Veterans. Arch Phys Med Rehabil. 2017 Mar;98(3):442-449. doi: 10.1016/j.apmr.2016.09.116. Epub 2016 Oct 3.

MeSH Terms

Conditions

Spinal Cord InjuriesPersonal Satisfaction

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesBehavior

Results Point of Contact

Title
Dr. Larissa Myaskovsky
Organization
VA Pittsburgh Healthcare System

Study Officials

  • Larissa Myaskovsky, PhD

    Center for Health Equity Research and Promotion

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2010

First Posted

November 8, 2010

Study Start

March 1, 2011

Primary Completion

August 1, 2013

Study Completion

September 1, 2013

Last Updated

June 27, 2019

Results First Posted

December 31, 2014

Record last verified: 2019-06

Locations