NCT04466839

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
411

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2020

Completed
9 days until next milestone

Study Start

First participant enrolled

July 2, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 10, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2020

Completed
Last Updated

September 14, 2021

Status Verified

September 1, 2021

Enrollment Period

6 months

First QC Date

June 23, 2020

Last Update Submit

September 6, 2021

Conditions

Keywords

Parkinson Disease,COVID-19Confinement

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Conditions of containment during the Covid-19 pandemic.

    Day 1

  • 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

Study Arms (1)

parkinsonian patients

Cohort of parkinsonian patients followed by doctors from the Parkinson Expert Centers in teaching hospitals.

Other: Questionnaire and interview

Interventions

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).

parkinsonian patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Centre Hospitalier Régionale Universitaire de Besançon

Besançon, 25030, France

Location

Centre Hospitalier Universitaire Lille

Lille, 59037, France

Location

Centre Hospitalier Universitaire de Marseille

Marseille, 13385, France

Location

Centre Hospitalier Universitaire de Nîmes - Caremeau

Nîmes, 30029, France

Location

Centre Hospitalier Universitaire de la Pitié-Salpêtrière

Paris, 75013, France

Location

Centre Hospitalier Universitaire de Reims

Reims, 51100, France

Location

Centre Hospitalier Universitaire de Rouen

Rouen, 76031, France

Location

CHU Toulouse

Toulouse, 31000, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Parkinson DiseaseCOVID-19

Interventions

Surveys and QuestionnairesInterviews as Topic

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Fabienne ORY MAGNE

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2020

First Posted

July 10, 2020

Study Start

July 2, 2020

Primary Completion

December 18, 2020

Study Completion

December 18, 2020

Last Updated

September 14, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations