ParkProReakt——帕金森病医疗主动干预方法的评估：一项随机对照试验的研究方案
ParkProReakt-evaluation of a proactive approach to healthcare in Parkinson's disease: a study protocol for a randomised controlled trial.
作者信息
van Munster Marlena, Stümpel Johanne, Pedrosa Anna J, Niemand Kati, Wellach Ingmar, Becker Dirk, Doblinger Isabel, Schmidt Kristina, Reiners René, Wolferts Daniel, Martin Anika, Nisslmüller Marius, Sohrabi Keywan, Groß Volker, Samans Birgit, Fischer Patrick, Ashraf Mohammed Osman, Wichartz Rebecca, Grzegorzek Marcin, Huang Xinyu, Piet Artur, Irsfeld Mona, Trense Christian, Olgemöller Paulina M, Seven Ümran, Folkerts Ann-Kristin, Kalbe Elke, Böbinger Hannes, Dapper Jens, Wohlfahrt Lars, Geraedts Max, Altschuck Natalie, Kerkemeyer Linda, Eggers Carsten, Pedrosa David J
机构信息
Department of Neurology, Philipps-Universität Marburg, Marburg, Germany.
Department of International Health, CAPHRI Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands.
出版信息
BMJ Public Health. 2025 Jul 21;3(2):e002265. doi: 10.1136/bmjph-2024-002265. eCollection 2025.
INTRODUCTION
The complexity of Parkinson's disease (PD) symptoms and the necessity for individualised, multidisciplinary and digital health technology-based care are widely acknowledged; however, access to specialist care remains limited, particularly in rural areas. Current healthcare systems are frequently ill-equipped to deliver timely, personalised interventions. In response to these challenges, the ParkProReakt project aims to enhance PD care through a proactive, technology-enabled, multidisciplinary approach designed to improve patient health-related quality of life (HRQoL) and alleviate caregiver burden.
METHODS AND ANALYSIS
A randomised controlled trial will assess the efficacy and cost-effectiveness of ParkProReakt-a proactive, multidisciplinary, digitally supported care model for community-dwelling people with Parkinson's disease (PwPD)-compared with standard care. We will recruit a total of 292 PwPD and their informal caregivers living in two diverse regions in Germany. The primary outcome measure will be patients' HRQoL as measured by the Parkinson's Disease Questionnaire, obtained at baseline, monthly and at completion of participation. Secondary outcomes comprise patients' subjective well-being, incidence or change of long-term care needs, global cognition and disease progression, utilisation of healthcare services, including hospitalisations, caregiver burden and healthcare costs. Statistical analysis will include t-tests for HRQoL changes, general linear model for confounders and multilevel models for centre effects. Secondary outcomes and cost-effectiveness (incremental cost-effectiveness ratio) will be analysed similarly using R and SPSS.
ETHICS AND DISSEMINATION
The study protocol has been approved by the Ethics Committees of the Medical Associations of Hesse and Hamburg. The results of our study will be reported to the funding body and disseminated through scientific publications and presentations at national and international conferences.
TRIAL REGISTRATION NUMBER
This study was registered with the German Registry for Clinical Studies (DRKS) in both German and English; number: DRKS00031092.
引言
帕金森病（PD）症状的复杂性以及基于个性化、多学科和数字健康技术的护理的必要性已得到广泛认可；然而，获得专科护理的机会仍然有限，尤其是在农村地区。当前的医疗保健系统往往缺乏提供及时、个性化干预措施的能力。为应对这些挑战，ParkProReakt项目旨在通过一种积极主动、技术支持的多学科方法来加强帕金森病护理，该方法旨在改善患者的健康相关生活质量（HRQoL）并减轻护理人员负担。
方法与分析
一项随机对照试验将评估ParkProReakt（一种针对社区居住的帕金森病患者（PwPD）的积极主动、多学科、数字支持的护理模式）与标准护理相比的疗效和成本效益。我们将招募总共292名居住在德国两个不同地区的PwPD及其非正式护理人员。主要结局指标将是通过帕金森病问卷测量的患者HRQoL，在基线、每月以及参与结束时获取。次要结局包括患者的主观幸福感、长期护理需求的发生率或变化、整体认知和疾病进展、医疗服务的使用情况，包括住院治疗、护理人员负担和医疗成本。统计分析将包括用于HRQoL变化的t检验、用于混杂因素的一般线性模型以及用于中心效应的多水平模型。次要结局和成本效益（增量成本效益比）将使用R和SPSS进行类似分析。
伦理与传播
该研究方案已获得黑森州和汉堡医学协会伦理委员会的批准。我们研究的结果将报告给资助机构，并通过科学出版物以及在国内和国际会议上的报告进行传播。
试验注册号
本研究已在德国临床研究注册中心（DRKS）以德语和英语注册；编号：DRKS00031092。
Zotero 插件