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临床试验/NCT04466839
NCT04466839已完成不适用

Evaluation of the Containment Impact Linked to the Covid-19 Pandemic in a Population of Parkinson Patients

University Hospital, Toulouse8 个研究点 分布在 1 个国家目标入组 411 人开始时间: 2020年7月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
411
试验地点
8
主要终点
Impact of containment related to the Covid-19 pandemic.

研究概览

简要总结

The consequences of COVID-19 in these already fragile patients should be evaluated. It will be important to appreciate the confinement consequences imposed on the patient on the course and impact of the disease.

These consequences can be assessed by the end of confinement and 6 months after the latter is lifted.

详细描述

Adaptation capacities are necessary to cope with the brutal and drastic changes imposed by the pandemic and its consequences. In Parkinson's disease, where there are routine situations with difficulties adjusting to newness, patients in the current situation may be particularly affected and present anxiety due to great difficulties in adaptation.

The repercussions in terms of symptoms (motor and non-motor) of the disease could be very significant. In this population already widely exposed to anxio-depressive symptoms (depression being a common symptom of Parkinson's disease, affecting up to 30 to 40% of patients outside of crisis periods), we can expect a risk increased psychiatric decompensation. The psychiatric consequences could not be limited to the current period but also concern long-term patients, in particular if there is decompensation of other symptoms of the disease (motors, complications linked to treatment, etc.).

The consequences of COVID-19 in these already fragile patients should be evaluated. It will be important to appreciate the confinement consequences imposed on the patient on the course and impact of the disease.

These consequences can be assessed by the end of confinement and 6 months after the latter is lifted.

This is an observational, French multicenter study, of an uncontrolled cohort of parkinsonian patients followed by doctors from Parkinson Expert Centers in hospitals.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patient followed by a doctor from the Parkinson Expert Center of the Toulouse University Hospital, Lille, Paris, Rouen, Nimes, Reims, Besancon, Marseille
  • And with idiopathic Parkinson's disease
  • Patients hospitalized or in consultation between 16/03/2020 and 16/05/2020.

排除标准

  • Atypical parkinsonian syndrome
  • Patient subject to a legal protection order (tutorship)
  • Patient not wishing to answer questions

结局指标

主要结局

Impact of containment related to the Covid-19 pandemic.

时间窗: 6 months after the end of the pandemic

To compare quality of life using Parkinson Disease Questionnaire-8 Items (PDQ-8 ), during the period of confinement linked to the Covid-19 pandemic and 6 months after the end of the pandemic in patients with idiopathic Parkinson's disease. The minimum value is "never" and maximum value is "always"

次要结局

  • The number of patients infected or possibly infected with Covid-19(6 months after the end of the pandemic)
  • Symptoms modifications(6 months after the end of the pandemic)
  • Conditions of containment during the Covid-19 pandemic.(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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