N/A
N=147
Self-management to Improve Function Following Amputation
Amputation, Limb Loss
Bottom Line
View on ClinicalTrials.gov: NCT02163811 ↗Enrolled (actual)
147
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Short Musculoskeletal Function Assessment (SMFA) — 32.34; 30.19 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- VETPALS (Behavioral); Individual Education Support Program (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Short Musculoskeletal Function Assessment (SMFA) |
32.34; 30.19 | — |
| PRIMARY Patient Health Questionnaire (PHQ-9) |
5.14; 5.87 | — |
| SECONDARY World Health Organization Quality of Life Scale (WHOQOL-BREF) Overall Quality of Life |
3.86; 3.77 | — |
| SECONDARY World Health Organization Quality of Life Scale (WHOQOL-BREF) Satisfaction With Health |
3.69; 3.32 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02163811). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.