Skip to main content
OpenTrials
Completed

NCT Number: NCT04466839

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

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Questionnaire and interview

Other

The questionnaires are Parkinson Disease Questionnaire-8 Items (PDQ-8) Visual Analog Scale (VAS) is visual analog scale visual numeric from 0 to 100, Neuropsychiatric Inventory-Questionnaire-Reduced (NPI-R) and Clinical Global Impression-Impairment (CGI-I).

Primary outcomes

  1. Impact of containment related to the Covid-19 pandemic.

    Time frame: 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"

Secondary outcomes

  1. Conditions of containment during the Covid-19 pandemic.

    Time frame: Day 1

    Describe in a cohort of Parkinson's patients the conditions of confinement during the confinement period linked to the Covid-19 pandemic such as lifestyle (patient living alone, patient living with a caregiver, patient living in nursing home) and continuing paramedical care (physiotherapist, speech therapist), thanks to a psychosocial assessment

  2. The number of patients infected or possibly infected with Covid-19

    Time frame: 6 months after the end of the pandemic

    Infected patients will be defined as having had a positive polymerase chain reaction (PCR) or compatible chest scanner. Patients potentially infected: patients who presented symptoms during the period which could suggest an infection by the Covid-19 virus: cough, fever and dyspnea

  3. Symptoms modifications

    Time frame: 6 months after the end of the pandemic

    Patients will be asked to list the 3 main symptoms that have changed during the confinement period

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: ERCO-Park

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 10, 2020
Registry last updated
Sep 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.