Self-management to Improve Function Following Amputation (VETPALS)

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.

Study Overview

• Status: Completed
• Conditions: Amputation, Limb Loss
• Intervention / Treatment: Behavioral: VETPALS; Behavioral: Individual Education Support Program

Detailed Description

Self-management interventions have been successful in improving outcomes across a broad variety of chronic illnesses including arthritis, asthma, diabetes, and hypertension. Initial evidence of the effectiveness of self-management following limb loss is promising, but limited. Only one published trial to date has examined self-management for amputees. The Promoting Amputee Life Skills (PALS) project, conducted by members of the current study team, designed and implemented an 8-week group-based intervention to improve self-management following limb loss. The current proposal builds upon previous research that has demonstrated the efficacy of the PALS self-management intervention, but addresses important next questions:

1. Is the PALS self-management intervention appropriate for Veterans, specifically considering the very high prevalence of diabetes and vascular disease?
2. Can it be housed and delivered within a health care system as opposed to existing community support groups?
3. Will the intervention be more effective for individuals who are new amputees?
4. Will a shorter format that also incorporates an option for video teleconferencing retain the efficacy of the original PALS intervention?

This study is a two-arm randomized controlled trial (RCT) to determine the efficacy of VETPALS. Study staff will screen and enroll Veterans with recent lower extremity limb loss within the last 6 months. Each participant will complete a baseline interview and then is sequentially placed into a cohort of 6-10 participants; each cohort will be randomized to the VETPALS group based self-management program (intervention) or an individual education support program (control). Once participants complete the randomized arm and follow-up assessments, they are free to participate in the other group. This ensures participants are offered both programs and are not deprived of a potentially valuable healthcare service.

• Study Type: Interventional
• Enrollment (Actual): 182
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • James A. Haley Veterans' Hospital, Tampa, FL
  • Minnesota
    • Minneapolis, Minnesota, United States, 55417
      • Minneapolis VA Health Care System, Minneapolis, MN
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Louis Stokes VA Medical Center, Cleveland, OH
  • Texas
    • Houston, Texas, United States, 77030
      • Michael E. DeBakey VA Medical Center, Houston, TX
  • Washington
    • Seattle, Washington, United States, 98108
      • VA Puget Sound Health Care System Seattle Division, Seattle, WA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: VETPALS; 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; 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.
ACTIVE_COMPARATOR: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
World Health Organization Quality of Life Scale (WHOQOL-BREF) Overall Quality of Life	Overall Quality of Life Scale. Range = 1-5 with higher values reflecting better quality of life.	6 months
World Health Organization Quality of Life Scale (WHOQOL-BREF) Satisfaction With Health	Satisfaction with Health Scale. Range = 1 to 5. Higher values represented better satisfaction with health	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Efficacy	Self-Efficacy for self-management of limb loss. Range = 0 to 10. Higher values reflect greater self-efficacy	6 month
Patient Activation Measure	Participant Active Engagement in Self-Care. Range = 1 to 5. Higher values reflect greater active engagement.	6 month
Social Problem Solving Inventory	Active Problem Solving. Range = 0 to 100. Higher values represent greater problem solving	6 month
Positive and Negative Affect Scale (PANAS) Positive Affect Score	Positive Affect Subscale. Range = 10 to 50. Higher values represent greater positive affect.	6 month

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: Johns Hopkins University; Spectrum Research, Inc.
• Investigators: Principal Investigator: Gail Latlief, DO, James A. Haley Veterans' Hospital, Tampa, FL

Publications and helpful links

General Publications

• 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.

Helpful Links

• Click here for more information about this study: Self-management to Improve Function Following Amputation

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2014
• Primary Completion (ACTUAL): March 21, 2019
• Study Completion (ACTUAL): March 21, 2019

Study Registration Dates

• First Submitted: June 5, 2014
• First Submitted That Met QC Criteria: June 11, 2014
• First Posted (ESTIMATE): June 16, 2014

Study Record Updates

• Last Update Posted (ACTUAL): August 5, 2020
• Last Update Submitted That Met QC Criteria: July 21, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Depression; Functional status; Self-management
• Other Study ID Numbers: D1143-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No