Clinical trial NCT02163811: Self-management to Improve Function Following Amputation
Official title: Self-management to Improve Function Following Amputation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation, Limb Loss
Keywords: Self-management
Functional status
Depression
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Spectrum Research, Inc.
name: Johns Hopkins University
First posted: 2014-06-16
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Short Musculoskeletal Function Assessment (SMFA)
timeFrame: 6 months
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 6 months
Secondary outcomes:
measure: World Health Organization Quality of Life Scale (WHOQOL-BREF) Overall Quality of Life
timeFrame: 6 months
measure: World Health Organization Quality of Life Scale (WHOQOL-BREF) Satisfaction With Health
timeFrame: 6 months
Other outcomes:
measure: Self-Efficacy
timeFrame: 6 month
measure: Patient Activation Measure
timeFrame: 6 month
measure: Social Problem Solving Inventory
timeFrame: 6 month
measure: Positive and Negative Affect Scale (PANAS) Positive Affect Score
timeFrame: 6 month
Locations:
city: Tampa
country: United States
facility: James A. Haley Veterans' Hospital, Tampa, FL
state: Florida
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System, Minneapolis, MN
state: Minnesota
city: Cleveland
country: United States
facility: Louis Stokes VA Medical Center, Cleveland, OH
state: Ohio
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center, Houston, TX
state: Texas
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
name: Aaron P Turner, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: James A. Haley Veterans' Hospital, Tampa, FL
name: Gail Latlief, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: James A. Haley Veterans' Hospital, Tampa, FL
name: Samuel L. Phillips, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.