Importance The travel required to receive deep brain stimulation (DBS) programming causes substantial burden on patients and limits who can access DBS therapy. Objective To evaluate the efficacy of home health DBS postoperative management in an effort to reduce travel burden and improve access. Design, Settings, and Participants This open-label randomized clinical trial was conducted at University of Florida Health from November 2017 to April 2020. Eligible participants had a diagnosis of Parkinson disease (PD) and were scheduled to receive DBS independently of the study. Consenting participants were randomized 1:1 to receive either standard of care or home health postoperative DBS management for 6 months after surgery. Primary caregivers, usually spouses, were also enrolled to assess caregiver strain. Interventions The home health postoperative management was conducted by a home health nurse who chose DBS settings with the aid of the iPad-based Mobile Application for PD DBS system. Prior to the study, the home health nurse had no experience providing DBS care. Main Outcomes and Measures The primary outcome was the number of times each patient traveled to the movement disorders clinic during the study period. Secondary outcomes included changes from baseline on the Unified Parkinson's Disease Rating Scale part III. Results Approximately 75 patients per year were scheduled for DBS. Of the patients who met inclusion criteria over the entire study duration, 45 either declined or were excluded for various reasons. Of the 44 patients enrolled, 19 of 21 randomized patients receiving the standard of care (mean [SD] age, 64.1 [10.0] years; 11 men) and 23 of 23 randomized patients receiving home health who underwent a minimum of 1 postoperative management visit (mean [SD] age, 65.0 [10.9] years; 13 men) were included in analysis. The primary outcome revealed that patients randomized to home health had significantly fewer clinic visits than the patients in the standard of care arm (mean [SD], 0.4 [0.8] visits vs 4.8 [0.4] visits; P < .001). We found no significant differences between the groups in the secondary outcomes measuring the efficacy of DBS. No adverse events occurred in association with the study procedure or devices. Conclusions and Relevance This study provides evidence supporting the safety and feasibility of postoperative home health DBS management. Trial Registration ClinicalTrials.gov Identifier: NCT02474459.

中文翻译：

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帕金森病深部脑刺激的家庭健康管理：一项随机临床试验。

重要性 接受深部脑刺激 (DBS) 编程所需的旅行给患者带来了巨大的负担，并限制了能够接受 DBS 治疗的人。目的评估家庭健康 DBS 术后管理在减轻旅行负担和改善访问方面的效果。设计、设置和参与者这项开放标签的随机临床试验于 2017 年 11 月至 2020 年 4 月在佛罗里达大学健康中心进行。符合条件的参与者被诊断为帕金森病 (PD)，并计划独立于研究接受 DBS。同意的参与者以 1:1 的比例随机接受术后 6 个月的标准护理或家庭健康术后 DBS 管理。主要照顾者，通常是配偶，也被纳入评估照顾者压力。干预 家庭健康术后管理由一名家庭健康护士进行，该护士借助基于 iPad 的移动应用程序为 PD DBS 系统选择 DBS 设置。在研究之前，家庭保健护士没有提供 DBS 护理的经验。主要结果和措施 主要结果是研究期间每位患者前往运动障碍诊所的次数。次要结果包括统一帕金森病评定量表第三部分基线的变化。结果 每年约有 75 名患者被安排接受 DBS。在整个研究期间符合纳入标准的患者中，有 45 人因各种原因拒绝或被排除在外。在入组的 44 名患者中，21 名随机接受标准治疗的患者中有 19 名（平均 [SD] 年龄，64.1 [10.0] 岁；11 名男性）和 23 名接受家庭保健的随机患者中的 23 名接受了至少 1 次术后管理访问（平均 [SD] 年龄，65.0 [10.9] 岁；13 名男性）被纳入分析。主要结果显示，随机分配到家庭健康组的患者就诊次数明显少于标准护理组的患者（平均 [SD]，0.4 [0.8] 次就诊 vs 4.8 [0.4] 次就诊；P < .001）。我们发现，在衡量 DBS 疗效的次要结果中，各组之间没有显着差异。没有发生与研究程序或设备相关的不良事件。结论和相关性 本研究提供了支持术后家庭健康 DBS 管理的安全性和可行性的证据。试验注册 ClinicalTrials.gov 标识符：NCT02474459。