Roberto Cilia, Fabiana Colucci, Antonio Suppa, Francesca Valentino, Carmen Terranova, Catia Leuzzi, Jessica Cordasco, Giulia Fusi, Simona Floridia, Francesca De Giorgi, Roberta Telese, Arianna Braccia, Alessandro Zampogna, Giulia Pinola, Martina Patera, Giorgio Belluscio, Sara Crivellari, Elisa Antoniazzi, Simona Cascino, Antonio Giaco, Alessio Masaracchio, Giacomina Clara Moreschi, Marisa Catotti, Roberto Eleopra
{"title":"非典型帕金森病的综合管理：基于远程护理的以患者为中心的家庭医疗服务--IMPACT 研究方案。","authors":"Roberto Cilia, Fabiana Colucci, Antonio Suppa, Francesca Valentino, Carmen Terranova, Catia Leuzzi, Jessica Cordasco, Giulia Fusi, Simona Floridia, Francesca De Giorgi, Roberta Telese, Arianna Braccia, Alessandro Zampogna, Giulia Pinola, Martina Patera, Giorgio Belluscio, Sara Crivellari, Elisa Antoniazzi, Simona Cascino, Antonio Giaco, Alessio Masaracchio, Giacomina Clara Moreschi, Marisa Catotti, Roberto Eleopra","doi":"10.1177/17562864241299347","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Objectives: </strong>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.</p><p><strong>Design: </strong>Multicenter, randomized, single-blind, controlled clinical trial involving 164 individuals with atypical parkinsonism.</p><p><strong>Methods and analysis: </strong>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.</p><p><strong>Ethic: </strong>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.</p><p><strong>Discussion: </strong>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.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier NCT05792332.</p>","PeriodicalId":22980,"journal":{"name":"Therapeutic Advances in Neurological Disorders","volume":"18 ","pages":"17562864241299347"},"PeriodicalIF":4.7000,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11970091/pdf/","citationCount":"0","resultStr":"{\"title\":\"Integrated management of atypical parkinsonism: a home-based patient-centered healthcare delivery based on telenursing-the IMPACT study protocol.\",\"authors\":\"Roberto Cilia, Fabiana Colucci, Antonio Suppa, Francesca Valentino, Carmen Terranova, Catia Leuzzi, Jessica Cordasco, Giulia Fusi, Simona Floridia, Francesca De Giorgi, Roberta Telese, Arianna Braccia, Alessandro Zampogna, Giulia Pinola, Martina Patera, Giorgio Belluscio, Sara Crivellari, Elisa Antoniazzi, Simona Cascino, Antonio Giaco, Alessio Masaracchio, Giacomina Clara Moreschi, Marisa Catotti, Roberto Eleopra\",\"doi\":\"10.1177/17562864241299347\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Objectives: </strong>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.</p><p><strong>Design: </strong>Multicenter, randomized, single-blind, controlled clinical trial involving 164 individuals with atypical parkinsonism.</p><p><strong>Methods and analysis: </strong>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.</p><p><strong>Ethic: </strong>Study protocol has been approved by the ethics committee of all participating centers. 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Integrated management of atypical parkinsonism: a home-based patient-centered healthcare delivery based on telenursing-the IMPACT study protocol.
Background: 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.
Objectives: 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.
Methods and analysis: 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.
Ethic: 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.
Discussion: 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.
期刊介绍：
Therapeutic Advances in Neurological Disorders is a peer-reviewed, open access journal delivering the highest quality articles, reviews, and scholarly comment on pioneering efforts and innovative studies across all areas of neurology. The journal has a strong clinical and pharmacological focus and is aimed at clinicians and researchers in neurology, providing a forum in print and online for publishing the highest quality articles in this area.
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