Self-management to Improve Function Following Amputation

Not Applicable

Completed

• Conditions: Amputation, Limb Loss
• Interventions: Behavioral: VETPALS; Behavioral: Individual Education Support Program

• Registration Number: NCT02163811
• Lead Sponsor: VA Office of Research and Development

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. 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.

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 Timeline

• Study First Submitted: 2014-06-05
• Study First Submitted QC: 2014-06-11
• Study First Posted: 2014-06-16
• Study Start: 2014-07-01
• Primary Completion: 2019-03-21
• Study Completion: 2019-03-21
• Status Verified: 2020-07
• Results First Submitted: 2020-07-01
• Results First Submitted QC: 2020-07-21
• Last Update Submitted: 2020-07-21
• Results First Posted: 2020-08-05
• Last Update Posted: 2020-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VETPALS	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).
Individual Education Support Program	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.

Primary Outcome Measures

Name	Time	Method
Short Musculoskeletal Function Assessment (SMFA)	6 months	Physical functioning will be measured using the Short Musculoskeletal Function Assessment (SMFA) Dysfunction Index. Range = 0 - 100 with higher values reflecting poorer physical function
Patient Health Questionnaire (PHQ-9)	6 months	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

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Louis Stokes VA Medical Center, Cleveland, OH; 🇺🇸 Cleveland, Ohio, United States

Michael E. DeBakey VA Medical Center, Houston, TX; 🇺🇸 Houston, Texas, United States

Minneapolis VA Health Care System, Minneapolis, MN; 🇺🇸 Minneapolis, Minnesota, United States

VA Puget Sound Health Care System Seattle Division, Seattle, WA; 🇺🇸 Seattle, Washington, United States

James A. Haley Veterans' Hospital, Tampa, FL; 🇺🇸 Tampa, Florida, United States