Home-Based Titration with Duodenal Infusion of Levodopa-Carbidopa Intestinal Gel in People with Parkinson’s Disease: An Observational Feasibility Study

IF 2.1 4区 医学 Q3 CLINICAL NEUROLOGY
Trine Hørmann Thomsen, Nick Schou Nielsen, Asher Lou Isenberg, Michael Hougaard Møller, Jesper Bøje Clausen, Inge Mona Schack Frederiksen, Louise Olsen, Mahsa Javidi, Jeanet Vilhelmsen, Marc Klee Olsen, Bo Biering-Sørensen
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Abstract

Background. Testing and titration of the right levodopa equivalent dose are usually performed during a hospital admission. However, optimal dose titration in people with Parkinson’s disease (PwPs) may depend on home environment, emotional stress, and physical activity of everyday life. Objective. Firstly, to evaluate the feasibility and safety of a home-based LCIG titration program and patients’/caregivers’ satisfaction. Secondly, to identify barriers and facilitators for home-based titration. Method. This study assesses the feasibility and safety of home-based titration of levodopa duodenal infusions with the use of self-reported evaluation questionnaires with open-ended questions included, registration of total time used, and number of contacts/visits. A telemedicine solution was used to remotely monitor the patients, adjust treatment, and provide support and guidance to patients and caregivers. Results. Ten of 12 PwPs (5 females and 7 males) completed the total titration program. Eight of the 12 PwPs were dependent on help. These 8 PwPs also had a high burden of nonmotor symptoms (NMS). Cognitive impairments varied in severity (range 16–30). Time spent with home visits was on average 93.4 minutes (ranging from 35 to 180 minutes), and the length of the total titration (LCIG initiation to termination of titration) was on average 3.4 days with 2–5 (mean 3.2) contacts/visits with PD team members. The average score on the satisfaction evaluation questionnaires was lower in the caregiver group (mean 31.8) than the PwP outcome (mean 36.2). Conclusions. Telehealth-assisted home-based titration programs are feasible due to the length of the titration period, number of contacts, and time spent in PwPs’ private homes, are rated satisfactory and safe by PwPs and caregivers, and may be a substitute for in-hospital treatment. Clinical recommendations including facilitators and barriers from a patient/caregiver perspective are displayed. This trial is registered with NCT4196647.
帕金森病患者在家中通过十二指肠输注左旋多巴-卡比多巴肠凝胶进行滴定:观察性可行性研究
背景。测试和滴定合适的左旋多巴等效剂量通常在入院时进行。然而,帕金森病患者的最佳剂量滴定可能取决于家庭环境、情绪压力和日常生活中的体力活动。研究目的首先,评估基于家庭的 LCIG 滴定计划的可行性和安全性,以及患者/护理人员的满意度。其次,确定居家滴定的障碍和促进因素。方法。本研究通过使用自我报告评估问卷(包括开放式问题)、登记所用总时间和联系/访问次数,评估左旋多巴十二指肠输液居家滴注的可行性和安全性。远程医疗解决方案用于远程监控患者、调整治疗方案以及为患者和护理人员提供支持和指导。结果。12 名患者中有 10 名(5 名女性和 7 名男性)完成了整个滴定计划。在这 12 名患者中,有 8 名需要依赖他人的帮助。这 8 名患者的非运动症状(NMS)负担也很重。认知障碍的严重程度各不相同(范围在 16-30 之间)。家访时间平均为 93.4 分钟(从 35 分钟到 180 分钟不等),整个滴定过程(从开始使用 LCIG 到终止滴定)平均为 3.4 天,与 PD 小组成员接触/家访 2-5 次(平均 3.2 次)。护理人员组满意度评估问卷的平均得分(平均 31.8 分)低于患者组(平均 36.2 分)。结论远程医疗辅助家庭滴定项目是可行的,因为滴定时间长、接触次数多、在患者私人家中花费的时间少,患者和护理人员对其满意度和安全性的评价也很高,可以替代院内治疗。临床建议包括从患者/护理者角度出发的促进因素和障碍。该试验已在 NCT4196647 上注册。
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来源期刊
Parkinson's Disease
Parkinson's Disease CLINICAL NEUROLOGY-
CiteScore
5.80
自引率
3.10%
发文量
0
审稿时长
18 weeks
期刊介绍: Parkinson’s Disease is a peer-reviewed, Open Access journal that publishes original research articles, review articles, and clinical studies related to the epidemiology, etiology, pathogenesis, genetics, cellular, molecular and neurophysiology, as well as the diagnosis and treatment of Parkinson’s disease.
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