Parkinson DiseaseERCO-ParkNCT04466839
Evaluation of the Containment Impact Linked to the Covid-19 Pandemic in a Population of Parkinson Patients
An observational study of Parkinson Disease and COVID, run by University Hospital, Toulouse at 8 sites in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease, COVID
- What is being tested?
- Questionnaire and interview
- How many people
- 411 participants
- Where
- 8 sitesFrance
- Study dates
- 2 Jul 2020to 18 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Atypical parkinsonian syndrome
- Patient subject to a legal protection order (tutorship)
- Patient not wishing to answer questions
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Centre Hospitalier Régionale Universitaire de Besançon
Besançon, 25030
Centre Hospitalier Universitaire Lille
Lille, 59037
Centre Hospitalier Universitaire de Marseille
Marseille, 13385
Centre Hospitalier Universitaire de Nîmes - Caremeau
Nîmes, 30029
Centre Hospitalier Universitaire de la Pitié-Salpêtrière
Paris, 75013
Centre Hospitalier Universitaire de Reims
Reims, 51100
Centre Hospitalier Universitaire de Rouen
Rouen, 76031
CHU Toulouse
Toulouse, 31000
About this study
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.
Read the 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.
- Conditions
- Parkinson Disease, COVID
- Being tested
- Questionnaire and interview
- Keywords
- Parkinson Disease,, COVID-19, Confinement
- Medical subject headings
- Parkinson Disease, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and interviewOther
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).
| Study group | Role | What they receive |
|---|---|---|
| parkinsonian patients | Cohort of parkinsonian patients followed by doctors from the Parkinson Expert Centers in teaching hospitals. Receives: Other: Questionnaire and interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: 6 months after the end of the pandemic
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: 6 months after the end of the pandemic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start2 Jul 2020
- Primary completion18 Dec 2020
- Study completion18 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 411 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabienne ORY MAGNE, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04466839
- Sponsor's protocol ID
- RC31/20/0193
- Acronym
- ERCO-Park
- Status last verified
- Sep 2021
- First submitted
- 23 Jun 2020
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34293534
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Containment Impact Linked to the Covid-19 Pandemic in a Population of Parkinson Patients
- ClinicalTrials.gov ID
- NCT04466839
- Acronym / sponsor ID
- ERCO-Park / RC31/20/0193
- Conditions
- Parkinson Disease, COVID
- Keywords
- Parkinson Disease,, COVID-19, Confinement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 411 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- 18 Dec 2020 (actual)
- Study completion
- 18 Dec 2020 (actual)
- First posted
- 10 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| parkinsonian patients | – | Other: Questionnaire and interviewCohort of parkinsonian patients followed by doctors from the Parkinson Expert Centers in teaching hospitals. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Atypical parkinsonian syndrome
- Patient subject to a legal protection order (tutorship)
- Patient not wishing to answer questions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire and interviewThe 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). | Other | parkinsonian patients |
Primary outcome
Impact of containment related to the Covid-19 pandemic.
Time frame: 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"
3 secondary outcomes
Conditions of containment during the Covid-19 pandemic.
Time frame: Day 1
The number of patients infected or possibly infected with Covid-19
Time frame: 6 months after the end of the pandemic
Symptoms modifications
Time frame: 6 months after the end of the pandemic
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Results publication: PubMed 34293534Fabbri 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabienne ORY MAGNE principal investigator
University Hospital, Toulouse
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and COVID, run by University Hospital, Toulouse at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of containment related to the Covid-19 pandemic. (time frame: 6 months after the end of the pandemic). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04466839, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.