Clinical trial NCT04466839: Evaluation of the Containment Impact Linked to the Covid-19 Pandemic in a Population of Parkinson Patients
Official title: Evaluation of the Containment Impact Linked to the Covid-19 Pandemic in a Population of Parkinson Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
COVID
Keywords: Parkinson Disease,
COVID-19
Confinement
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2020-07-10
Enrollment: 411
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Impact of containment related to the Covid-19 pandemic.
timeFrame: 6 months after the end of the pandemic
Secondary outcomes:
measure: Conditions of containment during the Covid-19 pandemic.
timeFrame: Day 1
measure: The number of patients infected or possibly infected with Covid-19
timeFrame: 6 months after the end of the pandemic
measure: Symptoms modifications
timeFrame: 6 months after the end of the pandemic
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre Hospitalier Régionale Universitaire de Besançon
city: Lille
country: France
facility: Centre Hospitalier Universitaire Lille
city: Marseille
country: France
facility: Centre Hospitalier Universitaire de Marseille
city: Nimes
country: France
facility: Centre Hospitalier Universitaire de Nîmes - Caremeau
city: Paris
country: France
facility: Centre Hospitalier Universitaire de la Pitié-Salpêtrière
city: Reims
country: France
facility: Centre Hospitalier Universitaire de Reims
city: Rouen
country: France
facility: Centre Hospitalier Universitaire de Rouen
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Fabienne ORY MAGNE
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.