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

Parkinson Disease Clinical Trial

— ERCO-Park  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04466839
• Other study ID #: RC31/20/0193
• Status: Completed
• Start date: July 2, 2020
• Est. completion date: December 18, 2020

Study information

• Verified date: September 2021
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 411
• Est. completion date: December 18, 2020
• Est. primary completion date: December 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COVID
• Parkinson Disease

Intervention

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).

Locations

Country	Name	City	State
France	Centre Hospitalier Régionale Universitaire de Besançon	Besançon
France	Centre Hospitalier Universitaire Lille	Lille
France	Centre Hospitalier Universitaire de Marseille	Marseille
France	Centre Hospitalier Universitaire de Nîmes - Caremeau	Nimes
France	Centre Hospitalier Universitaire de la Pitié-Salpêtrière	Paris
France	Centre Hospitalier Universitaire de Reims	Reims
France	Centre Hospitalier Universitaire de Rouen	Rouen
France	CHU Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (1)

Fabbri M, Leung C, Baille G, Béreau 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 sur — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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