NCT02163811

Brief Summary

Lower extremity amputations are a significant cause of morbidity, mortality, loss of function and reduced quality of life. Self-management (defined as the process by which an individual adopts an active role in managing the symptoms, treatment, consequences, and lifestyle changes inherent in living with a chronic condition) is an important mechanism for improving health and reducing disability. This study will evaluate a 5-week group-based self-management intervention for Veterans with lower extremity limb loss (VETPALS) and determine its impact upon physical and psychosocial functioning, patient activation, self-efficacy, problem solving, quality of life and positive affect. This study represents one of the only prospective randomized controlled trials of a behavioral intervention for individuals with limb loss. It is expected that results will be used to inform the integration of self-management interventions into the VA Amputation System of Care. The specific primary hypotheses are:

  1. 1.Individuals randomized to VETPALS will display greater improvements from baseline in physical functioning as measured by the MFA-SF than Veterans in the individual education support condition post-intervention and at a 6 month follow-up.
  2. 2.Individuals randomized to VETPALS will display greater improvements from baseline in psychosocial functioning as measured by the PHQ-9 than Veterans in the individual education support condition post-intervention and at a 6 month follow-up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

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

June 5, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 16, 2014

Completed
15 days until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2019

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

August 5, 2020

Completed
Last Updated

August 5, 2020

Status Verified

July 1, 2020

Enrollment Period

4.7 years

First QC Date

June 5, 2014

Results QC Date

July 1, 2020

Last Update Submit

July 21, 2020

Conditions

Amputation, Limb Loss

Keywords

Self-managementFunctional statusDepression

Outcome Measures

Primary Outcomes (2)

  • Short Musculoskeletal Function Assessment (SMFA)

    Physical functioning will be measured using the Short Musculoskeletal Function Assessment (SMFA) Dysfunction Index. Range = 0 - 100 with higher values reflecting poorer physical function

    6 months

  • Patient Health Questionnaire (PHQ-9)

    Psychosocial functioning will be evaluated by examining depression using the Patient Health Questionnaire Depression Module (PHQ-9). Range = 0-27 with higher scores indicating greater levels of depression

    6 months

Secondary Outcomes (2)

  • World Health Organization Quality of Life Scale (WHOQOL-BREF) Overall Quality of Life

    6 months

  • World Health Organization Quality of Life Scale (WHOQOL-BREF) Satisfaction With Health

    6 months

Other Outcomes (4)

  • Self-Efficacy

    6 month

  • Patient Activation Measure

    6 month

  • Social Problem Solving Inventory

    6 month

  • +1 more other outcomes

Study Arms (2)

VETPALS

EXPERIMENTAL

VETPALS is a five session course utilizing adult learning methods to teach self-management for people with life changes after amputation. The five sessions are held weekly, and are facilitated by a VA Puget Sound clinician in conjunction with a peer facilitator (Veteran with limb loss).

Behavioral: VETPALS

Individual Education Support Program

ACTIVE COMPARATOR

VETPALS facilitator provide post-amputation education materials from the Amputee Coalition, including First Step - A Guide for Adapting to Limb Loss and Side Step - A Guide to Preventing and Managing Diabetes and Its Complications. Veterans receive all usual care.

Behavioral: Individual Education Support Program

Interventions

VETPALSBEHAVIORAL

VETPALS is an adaption of an empirically supported self-management program, PALS (Promoting Amputee Life Skills). The PALS program demonstrated improved physical and psychosocial functioning when delivered in community-based support groups for amputees, but this program has not been adapted for the needs of Veterans and implemented in the VA healthcare system. VETPALS is a five session course for people with life changes after amputation. The five sessions are held weekly, and are facilitated by a VA clinician in conjunction with a peer facilitator (Veteran with limb loss). Veterans receive all usual care.

VETPALS
Individual Education Support ProgramBEHAVIORAL

VETPALS facilitator provide post-amputation education materials from the Amputee Coalition, including First Step - A Guide for Adapting to Limb Loss and Side Step - A Guide to Preventing and Managing Diabetes and Its Complications. Veterans receive all usual care.

Individual Education Support Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 18 or older
  • Has had transmetatarsal amputation (through the foot including Chopart and Lisfranc amputation), transtibial amputation (below the knee), transfemoral amputation (above the knee), knee disarticulation (at knee), or hip disarticulation (at hip) due to dysvascular disease/diabetes. These can all include a revision of an amputation.
  • Participant has a contact address and phone number so that s/he can be reached during the course of the study.\*
  • Enrolled within 6 months of amputation.
  • Speak and comprehend English.

You may not qualify if:

  • Inadequate cognitive or language function to consent or participate defined by greater than or equal to 6 errors on the SPMSQ or diagnosis of dementia or Alzheimer's disease.
  • Active substance use disorder identified by chart review and initial screening. Note: No personnel involved in the study may identify, directly or indirectly, any individual patient or participant in any report of such research or otherwise disclose patient or participant identities in any manner.
  • Major uncontrolled psychiatric illness (bipolar disorder, psychosis, severe suicidality) identified by chart review and confirmed as necessary by discussion with current providers.
  • Spinal Cord Injury

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

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417, United States

Location

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106, United States

Location

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

Location

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

Seattle, Washington, 98108, United States

Location

Related Publications (1)

  • Turner AP, Wegener ST, Williams RM, Ehde DM, Norvell DC, Yanez ND, Czerniecki JM, Study Group V. Self-Management to Improve Function After Amputation: A Randomized Controlled Trial of the VETPALS Intervention. Arch Phys Med Rehabil. 2021 Jul;102(7):1274-1282. doi: 10.1016/j.apmr.2021.02.027. Epub 2021 Apr 1.

    PMID: 33811854DERIVED

Related Links

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Limitations and Caveats

Results based on a sample of individuals with dysvascular disease/diabetes and may not generalize to all amputees.

Results Point of Contact

Title
Dr. Aaron Turner
Organization
VA Puget Sound Health Care System
Aaron.Turner@va.gov
(206) 277-6134

Study Officials

  • Aaron P Turner, PhD

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

    PRINCIPAL INVESTIGATOR

  • Gail Latlief, DO

    James A. Haley Veterans' Hospital, Tampa, FL

    PRINCIPAL INVESTIGATOR

  • Samuel L. Phillips, PhD

    James A. Haley Veterans' Hospital, Tampa, FL

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2014

First Posted

June 16, 2014

Study Start

July 1, 2014

Primary Completion

March 21, 2019

Study Completion

March 21, 2019

Last Updated

August 5, 2020

Results First Posted

August 5, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

US(5)