Self-management to Improve Function Following Amputation

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. 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.

Conditions

• Amputation, Limb Loss

Interventions

BEHAVIORAL

VETPALS

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.

BEHAVIORAL

Individual Education Support Program

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.

Sponsors & Collaborators

• Spectrum Research, Inc.

  collaborator INDUSTRY

• Johns Hopkins University

  collaborator OTHER

• VA Office of Research and Development

  lead FED

Principal Investigators

• Aaron P Turner, PhD · VA Puget Sound Health Care System Seattle Division, Seattle, WA

• Gail Latlief, DO · James A. Haley Veterans' Hospital, Tampa, FL

• Samuel L. Phillips, PhD · James A. Haley Veterans' Hospital, Tampa, FL

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-07-01

Primary Completion

2019-03-21

Completion

2019-03-21

Countries

• United States

Study Locations