Self-management to Improve Function Following Amputation

Completed · Not applicable

Conditions studied: Amputation, Limb Loss

In brief

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. 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. 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.

Key facts

Study ID: NCT02163811
Run by: VA Office of Research and Development
People needed: 182
Starts: 2014-07-01
Expected to finish: 2019-03-21
Last updated by the study team: 2020-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
The investigators will ask a participant who does not meet eligibility criteria because of inclusion criteria item 3 if s/he will have one in the near future, and if yes, permission to contact them again at that time. This allows the participant to be included, if interested and eligible, at a later date.

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

Where it is running

James A. Haley Veterans' Hospital, Tampa, FL — Tampa, Florida, United States
Minneapolis VA Health Care System, Minneapolis, MN — Minneapolis, Minnesota, United States
Louis Stokes VA Medical Center, Cleveland, OH — Cleveland, Ohio, United States
Michael E. DeBakey VA Medical Center, Houston, TX — Houston, Texas, United States
VA Puget Sound Health Care System Seattle Division, Seattle, WA — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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