Self-management to Improve Function Following Amputation

Overview

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.

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.