<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04466839</url>
  </required_header>
  <id_info>
    <org_study_id>RC31/20/0193</org_study_id>
    <nct_id>NCT04466839</nct_id>
  </id_info>
  <brief_title>Evaluation of the Containment Impact Linked to the Covid-19 Pandemic in a Population of Parkinson Patients</brief_title>
  <acronym>ERCO-Park</acronym>
  <official_title>Evaluation of the Containment Impact Linked to the Covid-19 Pandemic in a Population of Parkinson Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Toulouse</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The consequences of COVID-19 in these already fragile patients should be evaluated. It will&#xD;
      be important to appreciate the confinement consequences imposed on the patient on the course&#xD;
      and impact of the disease.&#xD;
&#xD;
      These consequences can be assessed by the end of confinement and 6 months after the latter is&#xD;
      lifted.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adaptation capacities are necessary to cope with the brutal and drastic changes imposed by&#xD;
      the pandemic and its consequences. In Parkinson's disease, where there are routine situations&#xD;
      with difficulties adjusting to newness, patients in the current situation may be particularly&#xD;
      affected and present anxiety due to great difficulties in adaptation.&#xD;
&#xD;
      The repercussions in terms of symptoms (motor and non-motor) of the disease could be very&#xD;
      significant. In this population already widely exposed to anxio-depressive symptoms&#xD;
      (depression being a common symptom of Parkinson's disease, affecting up to 30 to 40% of&#xD;
      patients outside of crisis periods), we can expect a risk increased psychiatric&#xD;
      decompensation. The psychiatric consequences could not be limited to the current period but&#xD;
      also concern long-term patients, in particular if there is decompensation of other symptoms&#xD;
      of the disease (motors, complications linked to treatment, etc.).&#xD;
&#xD;
      The consequences of COVID-19 in these already fragile patients should be evaluated. It will&#xD;
      be important to appreciate the confinement consequences imposed on the patient on the course&#xD;
      and impact of the disease.&#xD;
&#xD;
      These consequences can be assessed by the end of confinement and 6 months after the latter is&#xD;
      lifted.&#xD;
&#xD;
      This is an observational, French multicenter study, of an uncontrolled cohort of parkinsonian&#xD;
      patients followed by doctors from Parkinson Expert Centers in hospitals.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2, 2020</start_date>
  <completion_date type="Actual">December 18, 2020</completion_date>
  <primary_completion_date type="Actual">December 18, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Impact of containment related to the Covid-19 pandemic.</measure>
    <time_frame>6 months after the end of the pandemic</time_frame>
    <description>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.&#xD;
The minimum value is &quot;never&quot; and maximum value is &quot;always&quot;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Conditions of containment during the Covid-19 pandemic.</measure>
    <time_frame>Day 1</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of patients infected or possibly infected with Covid-19</measure>
    <time_frame>6 months after the end of the pandemic</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms modifications</measure>
    <time_frame>6 months after the end of the pandemic</time_frame>
    <description>Patients will be asked to list the 3 main symptoms that have changed during the confinement period</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">411</enrollment>
  <condition>Parkinson Disease</condition>
  <condition>COVID</condition>
  <arm_group>
    <arm_group_label>parkinsonian patients</arm_group_label>
    <description>Cohort of parkinsonian patients followed by doctors from the Parkinson Expert Centers in teaching hospitals.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire and interview</intervention_name>
    <description>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).</description>
    <arm_group_label>parkinsonian patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient followed by a doctor from the Parkinson Expert Center with idiopathic Parkinson's&#xD;
        disease between 16/03/2020 and 16/05/2020.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient followed by a doctor from the Parkinson Expert Center of the Toulouse&#xD;
             University Hospital, Lille, Paris, Rouen, Nimes, Reims, Besancon, Marseille&#xD;
&#xD;
          -  And with idiopathic Parkinson's disease&#xD;
&#xD;
          -  Patients hospitalized or in consultation between 16/03/2020 and 16/05/2020.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Atypical parkinsonian syndrome&#xD;
&#xD;
          -  Patient subject to a legal protection order (tutorship)&#xD;
&#xD;
          -  Patient not wishing to answer questions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fabienne ORY MAGNE</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Toulouse</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier Régionale Universitaire de Besançon</name>
      <address>
        <city>Besançon</city>
        <zip>25030</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Lille</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Marseille</name>
      <address>
        <city>Marseille</city>
        <zip>13385</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Nîmes - Caremeau</name>
      <address>
        <city>Nimes</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de la Pitié-Salpêtrière</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Reims</name>
      <address>
        <city>Reims</city>
        <zip>51100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Rouen</name>
      <address>
        <city>Rouen</city>
        <zip>76031</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Toulouse</name>
      <address>
        <city>Toulouse</city>
        <zip>31000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <results_reference>
    <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.</citation>
    <PMID>34293534</PMID>
  </results_reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>September 6, 2021</last_update_submitted>
  <last_update_submitted_qc>September 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Parkinson Disease,</keyword>
  <keyword>COVID-19</keyword>
  <keyword>Confinement</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04466839
org study id: RC31/20/0193
nct id: NCT04466839
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Case-Only
time perspective: Prospective
measure: Impact of containment related to the Covid-19 pandemic.
time frame: 6 months after the end of the pandemic
description: 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"
measure: Conditions of containment during the Covid-19 pandemic.
time frame: Day 1
description: 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
measure: The number of patients infected or possibly infected with Covid-19
time frame: 6 months after the end of the pandemic
description: 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
measure: Symptoms modifications
time frame: 6 months after the end of the pandemic
description: Patients will be asked to list the 3 main symptoms that have changed during the confinement period
arm group label: parkinsonian patients
description: Cohort of parkinsonian patients followed by doctors from the Parkinson Expert Centers in teaching hospitals.
intervention type: Other
intervention name: Questionnaire and interview
description: 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).
arm group label: parkinsonian patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Fabienne ORY MAGNE
role: Principal Investigator
affiliation: University Hospital, Toulouse
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
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.
PMID: 34293534
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Parkinson Disease
sharing ipd: No