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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease; COVID
• Intervention / Treatment: Other: Questionnaire and interview

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 411

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25030
    • Centre Hospitalier Régionale Universitaire de Besançon
  • Lille, France, 59037
    • Centre Hospitalier Universitaire Lille
  • Marseille, France, 13385
    • Centre Hospitalier Universitaire de Marseille
  • Nimes, France, 30029
    • Centre Hospitalier Universitaire de Nîmes - Caremeau
  • Paris, France, 75013
    • Centre Hospitalier Universitaire de la Pitié-Salpêtrière
  • Reims, France, 51100
    • Centre Hospitalier Universitaire de Reims
  • Rouen, France, 76031
    • Centre Hospitalier Universitaire de Rouen
  • Toulouse, France, 31000
    • CHU Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient followed by a doctor from the Parkinson Expert Center with idiopathic Parkinson's disease between 16/03/2020 and 16/05/2020.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
parkinsonian patients; Cohort of parkinsonian patients followed by doctors from the Parkinson Expert Centers in teaching hospitals.	Other: Questionnaire and interview; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of containment related to the Covid-19 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"	6 months after the end of the pandemic

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conditions of containment during the Covid-19 pandemic.	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	Day 1
The number of patients infected or possibly infected with Covid-19	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	6 months after the end of the pandemic
Symptoms modifications	Patients will be asked to list the 3 main symptoms that have changed during the confinement period	6 months after the end of the pandemic

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Fabienne ORY MAGNE, University Hospital, Toulouse

Publications and helpful links

General Publications

• Fabbri M, Leung C, Baille G, Bereau M, Brefel Courbon C, Castelnovo G, Carriere N, Damier P, Defebvre L, Doe de Maindreville A, Fluchere F, Fuzzatti M, Grabli D, Maltete D, Rousseau V, Sommet A A, Thalamas C, Thiriez C, Rascol O, Ory-Magne F. A French survey on the lockdown consequences of COVID-19 pandemic in Parkinson's disease. The ERCOPARK study. Parkinsonism Relat Disord. 2021 Aug;89:128-133. doi: 10.1016/j.parkreldis.2021.07.013. Epub 2021 Jul 13.

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2020
• Primary Completion (Actual): December 18, 2020
• Study Completion (Actual): December 18, 2020

Study Registration Dates

• First Submitted: June 23, 2020
• First Submitted That Met QC Criteria: July 9, 2020
• First Posted (Actual): July 10, 2020

Study Record Updates

• Last Update Posted (Actual): September 14, 2021
• Last Update Submitted That Met QC Criteria: September 6, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: COVID-19; Parkinson Disease,; Confinement
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; COVID-19; Parkinson Disease
• Other Study ID Numbers: RC31/20/0193

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No