Self-Management to Improve Function After Amputation: A Randomized Controlled Trial of the VETPALS Intervention
Abstract
Objective: To (1) evaluate the effects of a group-based self-management treatment intervention (VETPALS) on physical and psychosocial functioning (primary outcomes) and quality of life (secondary outcome) in individuals with amputation and (2) examine the feasibility and acceptability of the intervention in a large national health care system. Design: Randomized controlled trial with masked outcome assessment. Setting: Five Veterans Affairs medical centers geographically dispersed across the United States. Participants: 147 individuals with amputation during the past 2 years due to chronic limb threatening ischemia (N=147). Interventions: Participants were randomized into VETPALS (N =71) or education control (N=76). VETPALS consisted of a 4-hour workshop and 4 additional 2-hour sessions addressing self-management skills, health and activity, managing emotions, communication and social support, and maintaining goals and gains. Education control consisted of the provision of amputation-related educational materials and provider follow-up if requested. Main Outcome Measures: Primary outcomes were physical functioning (Short Musculoskeletal Functional Assessment) and psychosocial functioning (Patient Health Questionnaire-9). Secondary outcomes were quality of life (global) and quality of life (satisfaction with health) from the World Health Organization Quality of Life Scale (brief). Assessment was conducted at baseline, 6 weeks (treatment completion), and 6 months (follow-up).…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 147 participants or records.
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