Lower extremity amputations in the Veterans Administration Health Care System (VA) are a significant cause of morbidity, mortality, loss of function and reduced quality of life. The health care burden of limb loss is projected to rise over time as the increasing prevalence of diabetes and dysvascular disease result in a greater numbers of amputations. Consequently, the care of Veterans with amputation results in significant health care utilization and costs, and optimization of the VA Amputation System of Care remains an important priority. Adaptation to limb loss is a long-term process. There is increasing awareness that models of chronic illness care that facilitate an ongoing partnership between providers and patients offer an important framework to guide improvements in health and reductions in disability over time. One key ingredient of this partnership is self-management, the process by which an individual adopts an active role in managing the symptoms, treatment, physical and psychosocial consequences, and lifestyle changes inherent in living with a chronic condition. The overall objective of this study is to evaluate the efficacy of a 6-week group-based self- management intervention for Veterans with lower extremity limb loss (VETPALS). VETPALS is an adaptation of an empirically-supported self-management program (Promoting Amputee Life Skills: PALS) developed by members of the current study team. The PALS program has been shown to improve physical and psychosocial functioning when delivered in existing community- based support groups for amputees. However, the efficacy of this program, when adapted for the needs of Veterans and when delivered within the VA healthcare system, remains to be established.
The first aim of this study is to determine the impact of VETPALS upon the physical and psychosocial functioning of Veterans within the first 6 months of lower extremity limb loss.
The second aim i s to determine the impact upon the outcomes of patient activation, self-efficacy, problem solving, quality of life and positive affect.
The third aim examines factors that impact treatment fidelity and implementation. Sequential cohorts of 8 participants will be randomized to receive the intervention or enhanced usual care. A total of 408 participants will be recruited. Outcome assessment for both groups will be conducted at baseline, post-intervention, and at 6 month follow-up. The VA Amputation System of Care has already committed support to the future implementation of a self-management program for individuals with limb loss. However, this study is a necessary preliminary component of this roll-out effort and is expected to provide the specific empirical foundation for ensuring this program is effective and that it can be disseminated and implemented within VA in a way that provides maximal benefit and access to Veterans with limb loss.
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 6-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 ad 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 o inform the integration of self-management interventions into the VA Amputation System of Care.
