Judica Elda, Tropea Peppino, Bouça-Machado Raquel, Marín Mayca, Calarota Elisa, Cozma Liviu, Badea Raluca, Ahmed Mona, Brach Michael, Ferreira Joaquim J, Corbo Massimo
Department of Neurorehabilitation Sciences, Casa di Cura Igea, Milan, Italy.
Campus Neurológico Sénior, Torres Vedras, Portugal.
JMIR Res Protoc. 2023 Jul 24;12:e47916. doi: 10.2196/47916.
Alzheimer disease (AD) and Parkinson disease (PD) are the 2 most common neurodegenerative diseases affecting millions of people worldwide. The Personalized Integrated Care Promoting Quality of Life for Older People (PC4L) project proposes an integrated, scalable, and interactive care ecosystem that can be easily adapted to the needs of several neurodegenerative and chronic diseases, care institutions, and end user requirements.
The study protocol developed within the framework of the PC4L project aims to iteratively test the integrated platform and its modules, and focuses primarily on assessing the impact of the proposed solution (ie, the PC4L platform) on patients' quality of life, as well as its usability and feasibility on a large-scale sample size in 3 different scenarios (home, neurorehabilitation, and day care centers).
A prospective multicenter clinical study is conducted in 5 European countries (Germany, Italy, Portugal, Romania, and Spain) at 6 different pilot centers, for 3 months, in patients with PD, Parkinsonism, AD, and other dementias (ODs). Patients were randomized in a ratio of 1:1 to the intervention group (use of the PC4L system) or the control group (no intervention). The PC4L system consists mainly of a wristband for monitoring parameters such as steps and levels of physical activity, and the PC4L app, which includes different engaging functionalities. Both groups are assessed through baseline and end-of-study clinical evaluations, including assessment of quality of life through the EQ-5D-3L scale.
The study protocol is part of a project approved and funded by the European Commission Horizon 2020 (grant agreement number 875221). The ethics committees of all involved centers reviewed and approved the study protocol. The study began with the recruitment phase in September 2022, and enrollment ended in February 2023. Recruitment is now closed (April 2023). The results of this study are expected to be published in summer 2023. A total of 558 patients, 279 per study group, were recruited. The results will allow to clarify the impact of PC4L on quality of life, will assess the empowerment of patients and the medical resources use, as well as the usability of the final version of the PC4L system. It will also provide information on the support of the system as a tool to facilitate the decision-making process.
The PC4L project intends to test a technology-based, integrated, scalable, and interactive care platform on patients with neurodegenerative diseases and proposes a good coordinated care model between all involved actors. Future developments of the PC4L solution may involve caregivers and socio-health professionals in the decision-making process in order to facilitate efficient communication between all stakeholders and ensure reliable and protected access to data within Europe.
ClinicalTrials.gov NCT05538455; https://clinicaltrials.gov/study/NCT05538455.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47916.
阿尔茨海默病（AD）和帕金森病（PD）是全球影响数百万人的两种最常见的神经退行性疾病。老年人个性化综合护理促进生活质量（PC4L）项目提出了一种综合、可扩展且交互式的护理生态系统，该系统可轻松适应多种神经退行性疾病和慢性疾病、护理机构以及最终用户的需求。
在PC4L项目框架内制定的研究方案旨在对集成平台及其模块进行迭代测试，主要侧重于评估所提出的解决方案（即PC4L平台）对患者生活质量的影响，以及其在3种不同场景（家庭、神经康复和日间护理中心）下对大规模样本的可用性和可行性。
在5个欧洲国家（德国、意大利、葡萄牙、罗马尼亚和西班牙）的6个不同试点中心，对帕金森病、帕金森综合征、阿尔茨海默病和其他痴呆症（OD）患者进行为期3个月的前瞻性多中心临床研究。患者按1:1的比例随机分为干预组（使用PC4L系统）或对照组（无干预）。PC4L系统主要由一个用于监测步数和身体活动水平等参数的腕带以及包含不同参与功能的PC4L应用程序组成。两组均通过基线和研究结束时的临床评估进行评估，包括通过EQ-5D-3L量表评估生活质量。
该研究方案是由欧盟委员会“地平线2020”批准并资助的项目（资助协议编号875221）的一部分。所有参与中心的伦理委员会均审查并批准了该研究方案。该研究于2022年9月开始招募阶段，2023年2月结束招募。目前招募已结束（2023年4月）。本研究结果预计将于2023年夏季发表。共招募了558名患者，每个研究组279名。研究结果将有助于阐明PC4L对生活质量的影响，评估患者的自主能力和医疗资源使用情况，以及PC4L系统最终版本的可用性。它还将提供有关该系统作为促进决策过程工具的支持信息。
PC4L项目旨在对神经退行性疾病患者测试一个基于技术的、综合的、可扩展的和交互式的护理平台，并提出所有相关参与者之间良好协调的护理模式。PC4L解决方案的未来发展可能会让护理人员和社会卫生专业人员参与决策过程，以促进所有利益相关者之间的高效沟通，并确保在欧洲范围内可靠且受保护地访问数据。
ClinicalTrials.gov NCT05538455；https://clinicaltrials.gov/study/NCT05538455。
国际注册报告识别码（IRRID）：DERR1-10.2196/47916。
