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

Sponsor
University Hospital, Toulouse (Other)
Overall Status
Completed
CT.gov ID
NCT04466839
Collaborator
(none)
411
8
5.6
51.4
9.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
411 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Evaluation of the Containment Impact Linked to the Covid-19 Pandemic in a Population of Parkinson Patients
Actual Study Start Date :
Jul 2, 2020
Actual Primary Completion Date :
Dec 18, 2020
Actual Study Completion Date :
Dec 18, 2020

Arms and Interventions

Arm 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).

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Hospitalier Régionale Universitaire de Besançon Besançon France 25030
2 Centre Hospitalier Universitaire Lille Lille France 59037
3 Centre Hospitalier Universitaire de Marseille Marseille France 13385
4 Centre Hospitalier Universitaire de Nîmes - Caremeau Nimes France 30029
5 Centre Hospitalier Universitaire de la Pitié-Salpêtrière Paris France 75013
6 Centre Hospitalier Universitaire de Reims Reims France 51100
7 Centre Hospitalier Universitaire de Rouen Rouen France 76031
8 CHU Toulouse Toulouse France 31000

Sponsors and Collaborators

  • University Hospital, Toulouse

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT04466839
Other Study ID Numbers:
  • RC31/20/0193
First Posted:
Jul 10, 2020
Last Update Posted:
Sep 14, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Toulouse
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 14, 2021