NCT03733054

Brief Summary

The proportion of US Veterans who are women is currently at its highest point in history and is projected to continue increasing. Nonetheless, the literature regarding prosthetic and functional outcomes in women Veterans with lower extremity amputation (LEA) is nearly non-existent. Research in other healthcare systems indicates the presence of concerning gender differences in both prosthetic outcomes and functional mobility, with women being less likely to be prescribed a prosthesis, less likely to use it, and more likely to be dissatisfied than men. This mixed-methods study will use VA administrative data, qualitative interviews, and a patient survey to characterize women Veterans' outcomes as well as compare them to those of male Veterans, resulting in the largest study to date on women Veterans with LEA. Data from this rigorous evaluation will inform clinical care by identifying intervention targets to improve prosthetic and functional outcomes for this understudied population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
324

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

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 5, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2018

Completed
11 months until next milestone

Study Start

First participant enrolled

September 24, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

February 16, 2023

Status Verified

February 1, 2023

Enrollment Period

2.5 years

First QC Date

November 5, 2018

Last Update Submit

February 15, 2023

Conditions

Amputation

Keywords

femaleVeteransQuality of lifeProsthesesLower extremity amputationSurveys and questionnaireselectronic health records

Outcome Measures

Primary Outcomes (2)

  • Prosthetic prescription rate

    Prosthetic prescription determined based on data in VA electronic medical records Sample will include those with an amputation between October 2004 (start of FY2005) and September 2018 (end of FY2018)

    12-months post first major amputation

  • Use of prosthesis

    Orthotics and Prosthetics Users' Survey (OPUS) - 2 items Item 1: Hours per day of wear time for prosthesis Item 2: Hours per day of walking on prosthesis

    July 2020-December 2021

Secondary Outcomes (5)

  • Functional satisfaction with prosthesis

    July 2020-December 2021

  • Overall satisfaction with prosthesis

    July 2020-December 2021

  • Aesthetic satisfaction with prosthesis

    July 2020-December 2021

  • Functional mobility

    July 2020-December 2021

  • Health-related quality of life

    July 2020-December 2021

Other Outcomes (1)

  • Amputee Single Item Mobility Measure (AMPSIMM)

    July 2020-December 2021

Study Arms (2)

Men

Men with lower limb amputation

Women

Women with lower limb amputation

Eligibility Criteria

Sexall(Gender-based eligibility)
Gender Eligibility DetailsSpecified above. However, gender-based criteria ONLY applies to Aim 2 interviews. For Aim 1 administrative data and Aim 3 surveys, both men and women will be included.
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

VHA patients - national sample

You may qualify if:

  • Aim 1 (prosthetic prescription, device types, and time to prescription using administrative data):
  • Male or female Veteran with a first major lower extremity amputation performed in VA Medical Center between FY05 and FY18, regardless of etiology.
  • Amputation will be determined based on having an inpatient or outpatient procedure code for a major lower extremity amputation (ICD-9 CM 84.13-84.19; ICD-10 codes and CPT codes also assessed but not detailed here because of space limitations).
  • Patients will need to have had at least one VHA outpatient encounter in the 24 months prior to their amputation.
  • Aim 2 (qualitative interviews with women):
  • Women Veteran VHA patients who have had a major lower extremity amputation, self-reported receiving a prescription for a prosthesis at least 12 months prior, and alive.
  • Aim 3 (prosthetic use, satisfaction, and functional mobility using survey data):
  • Men and women Veteran VHA patients who have had a major lower extremity amputation, self-reported prescription for a prosthesis at least 12 months prior, and be alive.

You may not qualify if:

  • Aim 1 (prosthetic prescription, device types, and time to prescription using administrative data):
  • prior major amputation
  • unable to ambulate prior to amputation , including spinal cord injury, paraplegia, hemiplegia, or quadriplegia
  • dementia
  • hemipelvectomy or hip disarticulation
  • ankle disarticulation
  • bilateral amputation or not definitive
  • death in the 3 weeks after index amputation
  • Aim 2 (Qualitative interviews with women):
  • Specified based on eligibility criteria above.
  • Aim 3 (prosthetic use, satisfaction, and functional mobility using survey data):
  • Specified based on eligibility criteria above.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108, United States

Location

Related Publications (1)

  • Lehavot K, Young JP, Thomas RM, Williams RM, Turner AP, Norvell DC, Czerniecki JM, Korpak A, Littman AJ. Voices of Women Veterans with Lower Limb Prostheses: a Qualitative Study. J Gen Intern Med. 2022 Sep;37(Suppl 3):799-805. doi: 10.1007/s11606-022-07572-8. Epub 2022 Sep 1.

    PMID: 36050521RESULT

Biospecimen

Retention: NONE RETAINED

No biospecimens are being collected.

Study Officials

  • Alyson J. Littman, PhD MPH

    VA Puget Sound Health Care System Seattle Division, Seattle, WA

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 5, 2018

First Posted

November 7, 2018

Study Start

September 24, 2019

Primary Completion

March 31, 2022

Study Completion

December 1, 2022

Last Updated

February 16, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

A de-identified, anonymized dataset will be created and shared.

Shared Documents
STUDY PROTOCOL, ICF
Access Criteria
Subject to IRB approval, de-identified data will be released to a local VAPSHCS and/or national VA research data repository for release to non-VA protocols. The VA research data repository administrator will be responsible for reviewing and responding to requests to release data to non-VA requesters. A data use agreement compliant with VHA Handbooks 1200.12 and 1605.1 will be required between VHA and the requester. Review and approval by VA privacy officer is required prior to disclosure.

Locations

US(1)