Cilia Roberto, Colucci Fabiana, Suppa Antonio, Valentino Francesca, Terranova Carmen, Leuzzi Catia, Cordasco Jessica, Fusi Giulia, Floridia Simona, De Giorgi Francesca, Telese Roberta, Braccia Arianna, Zampogna Alessandro, Pinola Giulia, Patera Martina, Belluscio Giorgio, Crivellari Sara, Antoniazzi Elisa, Cascino Simona, Giaco Antonio, Masaracchio Alessio, Moreschi Giacomina Clara, Catotti Marisa, Eleopra Roberto
Department of Clinical Neurosciences, Parkinson and Movement Disorders Unit, Fondazione IRCCS Istituto Neurologico Carlo Besta, via Celoria 11, Milano 20133, Italy.
Department of Clinical Neurosciences, Parkinson and Movement Disorders Unit, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milano, Italy.
Ther Adv Neurol Disord. 2025 Apr 3;18:17562864241299347. doi: 10.1177/17562864241299347. eCollection 2025.
People with atypical parkinsonism, such as multiple system atrophy and progressive supranuclear palsy, experience a wide range of motor and non-motor symptoms associated with the increasing complexity of care delivery and the increased risk of complications and hospital admissions.
To investigate the efficacy and cost-effectiveness of a 12-month remote home-based integrated program aiming to improve healthcare delivery coordinated by a nurse specialized in the management of individuals with atypical parkinsonism (parkinsonism nurse specialist, PKNS) compared to the standard-of-care model.
Multicenter, randomized, single-blind, controlled clinical trial involving 164 individuals with atypical parkinsonism.
Participants will be randomized 1:1 in intervention (PKNS) and control (standard-of-care) arms. Assessments will be undertaken at baseline and after 6 and 12 months. Primary outcome measure is the Parkinson's Disease Questionnaire 39-items scale total score. Secondary measures include the clinical scales testing motor and non-motor symptoms, caregiver burden, adherence to therapy, cumulative disease burden and the number of unplanned hospital visits/admissions during the study period. The cost-effectiveness of this method will be evaluated by using the EuroQoL-5, which estimates the incremental cost per quality-adjusted life-years gain. Real-life motor autonomy will be objectively measured by collecting waist-worn wearable data on gait parameters (automatically detecting motor patterns indicative of freezing of gait and falls) in all subjects for five consecutive days each month during the 12-month duration of the study.
Study protocol has been approved by the ethics committee of all participating centers. The study is conducted according to good clinical practice and the Declaration of Helsinki.
An integrated remote care model at home coordinated by a specialized nurse in the management of parkinsonism (Telenursing) could offer significant benefits to patients and healthcare professionals through better health education, continuity of care, and careful monitoring of complications.
ClinicalTrials.gov identifier NCT05792332.
患有非典型帕金森症（如多系统萎缩和进行性核上性麻痹）的患者会经历各种各样的运动和非运动症状，这与护理服务的复杂性增加以及并发症和住院风险的上升有关。
研究一项为期12个月的基于家庭的远程综合项目的有效性和成本效益，该项目旨在改善由专门管理非典型帕金森症患者的护士（帕金森症护士专家，PKNS）协调的医疗服务，并与标准护理模式进行比较。
多中心、随机、单盲、对照临床试验，涉及164名非典型帕金森症患者。
参与者将按1:1随机分为干预组（PKNS）和对照组（标准护理组）。在基线、6个月和12个月后进行评估。主要结局指标是帕金森病问卷39项量表总分。次要指标包括测试运动和非运动症状的临床量表、照顾者负担、治疗依从性、累积疾病负担以及研究期间非计划住院就诊/入院次数。将使用欧洲五维健康量表评估该方法的成本效益，该量表估计每获得一个质量调整生命年的增量成本。在为期12个月的研究期间，每月连续5天收集所有受试者腰部佩戴的可穿戴设备的步态参数数据（自动检测表明步态冻结和跌倒的运动模式），以客观测量现实生活中的运动自主性。
研究方案已获得所有参与中心伦理委员会的批准。本研究按照良好临床实践和《赫尔辛基宣言》进行。
由专门管理帕金森症的护士协调的家庭综合远程护理模式（远程护理），通过更好的健康教育、护理连续性和对并发症的密切监测，可为患者和医疗专业人员带来显著益处。
ClinicalTrials.gov标识符NCT05792332。
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