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).

Results

Participants randomized to VETPALS reported significantly improved psychosocial functioning and quality of life (satisfaction with health) relative to controls at 6 months (B=1.84; 95% confidence interval, 0.37,3.31 and B=−0.61; 95% confidence interval, −1.11,-0.12, respectively). There were no differences in physical functioning over time between VETPALS and education control at either time point. Follow-up multiple imputation sensitivity analyses produced an identical pattern of results. Among VETPALS participants, treatment initiation was low (56%), but treatment retention (93% attended 4 of 5 classes) and overall satisfaction (100% reported very helpful or better and would recommend to a friend) were high.

Conclusions

Group-based self-management improves psychosocial functioning for individuals with amputation due to chronic limb threatening ischemia. In-person participation is challenging for this population, but individuals who successfully initiate treatment typically persist and are highly satisfied.

中文翻译：

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截肢后自我管理以改善功能：VETPALS 干预的随机对照试验

客观的

(1) 评估基于团体的自我管理治疗干预 (VETPALS) 对截肢患者的身体和心理社会功能（主要结果）和生活质量（次要结果）的影响，以及 (2) 检查可行性和可接受性对大型国家医疗保健系统的干预。

设计

具有隐蔽结果评估的随机对照试验。

环境

五个退伍军人事务部医疗中心分布在美国各地。

参与者

147 人在过去 2 年内因慢性肢体威胁缺血而截肢（N = 147）。

干预

参与者被随机分配到 VETPALS (N = 71) 或教育控制组 (N = 76)。VETPALS 包括一个 4 小时的研讨会和另外 4 个 2 小时的课程，内容涉及自我管理技能、健康和活动、管理情绪、沟通和社会支持，以及保持目标和收益。教育控制包括提供与截肢相关的教育材料，并在需要时对提供者进行跟进。

主要观察指标

主要结果是身体功能（短期肌肉骨骼功能评估）和社会心理功能（患者健康问卷 9）。次要结果是来自世界卫生组织生活质量量表（简要）的生活质量（全球）和生活质量（对健康的满意度）。在基线、6 周（治疗完成）和 6 个月（随访）时进行评估。

结果

随机分配到 VETPALS 的参与者在 6 个月时报告了相对于对照组的心理社会功能和生活质量（对健康的满意度）显着改善（B =1.84；95% 置信区间，0.37、3.31 和B =-0.61；95% 置信区间，-1.11 ,-0.12，分别）。在任一时间点，VETPALS 和教育控制之间的身体机能随着时间的推移没有差异。后续多重插补敏感性分析产生了相同的结果模式。在 VETPALS 参与者中，治疗开始率低 (56%)，但治疗保留率 (93% 参加了 5 节课中的 4 节课) 和总体满意度(100% 报告非常有帮助或更好并会推荐给朋友) 很高。

结论

基于团体的自我管理可改善因慢性肢体威胁缺血而截肢的个体的心理社会功能。对于这一人群来说，亲自参与具有挑战性，但成功开始治疗的个人通常会坚持下去并且非常满意。