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临床试验/NCT05538455
NCT05538455已完成不适用

ProCare4Life Pilot 3 Clinical Study: Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases

Casa di Cura Privata del Policlinico SpA1 个研究点 分布在 1 个国家目标入组 558 人开始时间: 2022年9月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
558
试验地点
1
主要终点
EuroQol5D3L

研究概览

简要总结

Personalized Integrated Care Promoting Quality of Life for Elderly People (ProCare4Life, PC4L) project was created to finalize a digital platform with integrated sensors , for monitoring the health status of the elderly subjects with neurodegenerative diseases and comorbidities.

In fact, an integrated care platform - able to establish correlations between comorbidities, investigate the intake of different drugs, mitigate potential health risks, study the social variables and promote unified therapeutic procedures or social services - could help patients, caregivers, healthcare professionals and social health workers to monitor various diseases parameters.

The main contribution of the PC4L project is to propose an integrated, scalable and interactive care system that can be easily adapted to the reality of various chronic diseases, care institutions and end-user needs, for the benefit of all the actors involved. The main expected results are to improve patients' quality of life, enable an active life and better disease management, support professionals in decision making, facilitate efficient communication between all stakeholders and ensure reliable and secure access to data at the within Europe.

详细描述

There is an urgent need to increase the efficiency and sustainability of health and social care systems across Europe, as there is a growing trend in public spending, which is expected to reach 14% of GDP by 2030. The main causes are the aging of the population, and the increase of chronic diseases, including cardiovascular diseases, diabetes, asthma, mental and physical disorders and neurodegenerative conditions. Comorbidities and the confluence of various chronic diseases is increasingly common in the elderly, which increases the need to develop models and tools to improve integrated health systems.

Population aging has also led to major reforms in long-term care policies and systems in many European countries, increasing the need for alternatives. This implies the need for help with housework or other practical errands, transportation by doctors or social visits, social companionship, emotional guidance, or help in organizing professional care. In most European countries, much of the care people over 60 receive is informal care.

Among the most common chronic diseases in the elderly population, neurocognitive deterioration in the stages of dementia associated with Alzheimer's and Parkinson's are the most disabling. Today, more than 10 million Europeans live with neurocognitive disorders in stages of dementia.

This situation can be improved through the creation of an integrated care platform, able to establish correlations between co-morbidities, investigate the use of the intake of different drugs, mitigate potential health risks, study the social variables involved and promote unified therapeutic procedures or social services. This solution could help patients, health professionals and social health workers to monitor various diseases, also considering the social context. In addition, people with chronic diseases face difficulties in their daily life and need specialized care services and care. This situation imposes high burdens on the public budget, which require particular attention to adequately address the sustainability of the social and health system in Europe.

The main contribution of the PC4L project is to propose an integrated, scalable and interactive care system that can be easily adapted to the reality of various chronic diseases, care institutions and end-user needs, for the benefit of all the actors involved (e.g. patients, caregivers and health experts). The main expected results are to improve patients' quality of life, enable an active life and better disease management, support professionals in decision making, facilitate efficient communication between all stakeholders and ensure reliable and secure access to data at the within Europe.This study is part of the European multicenter project Horizon 2020, called Personalized Integrated Care Promoting Quality of Life for Elderly People (ProCare4Life, PC4L), which involves several European partners and was created with the aim of finalizing a digital platform with integrated sensors, aimed at home monitoring of health status and treatment of the elderly patient with Parkinson's disease or Alzheimer's disease and other dementias.The PC4L Project was funded by the European Community Horizon 2020 innovation and research program (grant agreement No 875221), for the development of an international research project aimed at exploring the potential of assistive technologies in monitoring the behavior of elderly subjects. The project involves in fact the elderly population suffering from chronic neurological diseases and other comorbidities such as diabetes mellitus and arthritis. This project also aims to provide home support to the caregivers of subjects affected by these diseases.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with a clinical diagnosis of Parkinson's (Hoehn and Yahr between II and IV) or another parkinsonian syndrome, Alzheimer's disease, or another dementia
  • •65 years of age or more
  • •Willingness to participate in the study
  • •Able and willing to provide informed consent or have a legal representative responsible for the signature

排除标准

  • •Presence of fever and / or acute infection such as COVID19 / flu

研究组 & 干预措施

Experimental group, use of PC4L solutions

Experimental

Participants who will use the PC4L solutions for the estabilished period of time, in the selected scenario (home, neurorehabilitation and daycare centers), and will receive recommendations in the PC4L app

干预措施: PC4L solutions (Device)

Control group, no use of PC4L solutions

No Intervention

Participants who will be monitored for the estabilished period of time, in the selected scenario (home, neurorehabilitation and daycare centers), and will only receive written recommendations

结局指标

主要结局

EuroQol5D3L

时间窗: up to three months

Improvement of the quality of life in the 'experimental' group of patients who use the PC4L platform for a period of three months, compared to the control group, equal to 10% according to the scale EuroQol5D3L: the primary outcome of the study will be the difference in quality of life between groups, measured by the EuroQol5D3L scale at the end of the study. Sample size calculation was based on a previous study (Fan X, et al. Assessment of Health-Related Quality of Life between People with Parkinson's Disease and Non-Parkinson's: Using Data Drawn from the '100 for Parkinson's' Smartphone-Based Prospective Study. Int J Environ Res Public Health. 2018) that compared the quality of life of two groups of patients. It was estimated that a total of 558 patients, 279 per study group, will be necessary to achieve an improvement of 10% in EuroQol5D3L, with 95% power.

次要结局

  • State-Trait-Anxiety-Inventory (STAI)(up to three months)
  • Pittsburgh Sleep quality index (PSQI)(up to three months)
  • MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)(up to three months)
  • Falls Efficacy Scale International (FES-I)(up to three months)
  • CLINICAL DEMENTIA RATING SCALE (CDRS)(up to three months)
  • Patient assessment of chronic illness care (PACIC)(up to three months)
  • Short Assessment of Patient Satisfaction (SAPS)(up to three months)
  • Barthel Index (BI)(up to three months)
  • System Usability Scale (SUS)(up to three months)
  • Cumulative Illness Rating Scale-Geriatric (CIRS-G)(up to three months)

研究者

发起方
Casa di Cura Privata del Policlinico SpA
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elda Judica

Principal Investigator

Casa di Cura Privata del Policlinico SpA

研究点 (1)

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