<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/NCT04485468</url>
  </required_header>
  <id_info>
    <org_study_id>RC31/20/0184</org_study_id>
    <nct_id>NCT04485468</nct_id>
  </id_info>
  <brief_title>Integrated Parkinson Care Networks: Assessment of Economics and Socials Barriers</brief_title>
  <acronym>ECOSO-ICAREPD</acronym>
  <official_title>Integrated Parkinson Care Networks: Assessment of Economics and Socials Barriers to the Optimal Care Pathway for Parkinson Disease 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>
      According to the latest public health report in France, Parkinson's disease (PD) affects&#xD;
      around 160,000 patients.&#xD;
&#xD;
      It is therefore essential to estimate the overall consumption of medical and non-medical&#xD;
      resources by patients with PD in order to characterize the share of medical and non-medical&#xD;
      care reimbursed by health insurance, the share of medical and non-medical care not&#xD;
      reimbursed. by health insurance, as well as the share of formal and informal care in order to&#xD;
      identify potential economic barriers to an optimal care path for patients with PD. It is also&#xD;
      necessary to have information on the socio-economic characteristics and the place of&#xD;
      residence of the resident in order to estimate the impact of these determinants on an optimal&#xD;
      course of care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      According to the latest public health report in France, Parkinson's disease (PD) affects&#xD;
      around 160,000 patients&#xD;
&#xD;
      The coordination of the care pathway for patients with Parkinson disease has been improved&#xD;
      since the implementation on the national territory of 7 interregional coordination centers&#xD;
      and 25 regional expert centers in 2012.&#xD;
&#xD;
      Health insurance reimburses 100% of direct medical and non-medical care as soon as patients&#xD;
      are registered in Long-Term Condition n°16. However, we currently have little information&#xD;
      about care that is not recognized for financial coverage by health insurance.&#xD;
&#xD;
      It is therefore essential to estimate the overall consumption of medical and non-medical&#xD;
      resources by patients with PD in order to characterize the share of medical and non-medical&#xD;
      care reimbursed by health insurance, the share of medical and non-medical care not&#xD;
      reimbursed. by health insurance, as well as the share of formal and informal care in order to&#xD;
      identify potential economic barriers to an optimal care path for patients with PD. It is also&#xD;
      necessary to have information on the socio-economic characteristics and the place of&#xD;
      residence of the resident in order to estimate the impact of these determinants on an optimal&#xD;
      course of care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 12, 2021</start_date>
  <completion_date type="Actual">July 2, 2021</completion_date>
  <primary_completion_date type="Actual">July 2, 2021</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>Identify the economic barriers to an optimal care path</measure>
    <time_frame>Day 0</time_frame>
    <description>It is the collection of the number of resources consumed and the remainder to be borne by the patient as well as the number of hours of informal help that will be valued using the replacement cost approach.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Identify and quantify the cost of the care pathway for patients with Parkinson's disease</measure>
    <time_frame>Day 0</time_frame>
    <description>it is the quantification of the number of resources consumed and identification of the unit costs for each type of resources consumed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>identify socio-economic determinants</measure>
    <time_frame>Day 0</time_frame>
    <description>identify the socio-economic and territorial determinants that could have an impact on an optimal care path.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">72</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Parkinson's disease patients</arm_group_label>
    <description>Parkinson's disease patients and over 18 years old</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>The patient answers the questionnaire directly following his consultation or teleconsultation or may arrange a telephone appointment with the clinical research associate a little later.</description>
    <arm_group_label>Parkinson's disease patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Parkinson's disease patients and over 18 years old&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with Parkinson's disease of any stage of severity&#xD;
&#xD;
          -  Patients over 18 years of age&#xD;
&#xD;
          -  Patients living at home&#xD;
&#xD;
          -  Patient consultant at the expert center Parkinson's at Toulouse University Hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant and lactating woman&#xD;
&#xD;
          -  Patient under guardianship, curatorship or safeguard of justice&#xD;
&#xD;
          -  Person who does not understand French to be able to answer the questionnaire&#xD;
&#xD;
          -  Patient who participated or participated in the iCare PD project&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Olivier Rascol</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Toulouse</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Toulouse</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>June 19, 2023</last_update_submitted>
  <last_update_submitted_qc>June 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Parkinson Disease,</keyword>
  <keyword>Socio-economic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT04485468
org study id: RC31/20/0184
nct id: NCT04485468
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
According to the latest public health report in France, Parkinson's disease (PD) affects
      around 160,000 patients.

      It is therefore essential to estimate the overall consumption of medical and non-medical
      resources by patients with PD in order to characterize the share of medical and non-medical
      care reimbursed by health insurance, the share of medical and non-medical care not
      reimbursed. by health insurance, as well as the share of formal and informal care in order to
      identify potential economic barriers to an optimal care path for patients with PD. It is also
      necessary to have information on the socio-economic characteristics and the place of
      residence of the resident in order to estimate the impact of these determinants on an optimal
      course of care.
According to the latest public health report in France, Parkinson's disease (PD) affects
      around 160,000 patients

      The coordination of the care pathway for patients with Parkinson disease has been improved
      since the implementation on the national territory of 7 interregional coordination centers
      and 25 regional expert centers in 2012.

      Health insurance reimburses 100% of direct medical and non-medical care as soon as patients
      are registered in Long-Term Condition n°16. However, we currently have little information
      about care that is not recognized for financial coverage by health insurance.

      It is therefore essential to estimate the overall consumption of medical and non-medical
      resources by patients with PD in order to characterize the share of medical and non-medical
      care reimbursed by health insurance, the share of medical and non-medical care not
      reimbursed. by health insurance, as well as the share of formal and informal care in order to
      identify potential economic barriers to an optimal care path for patients with PD. It is also
      necessary to have information on the socio-economic characteristics and the place of
      residence of the resident in order to estimate the impact of these determinants on an optimal
      course of care.
observational model: Case-Only
time perspective: Prospective
measure: Identify the economic barriers to an optimal care path
time frame: Day 0
description: It is the collection of the number of resources consumed and the remainder to be borne by the patient as well as the number of hours of informal help that will be valued using the replacement cost approach.
measure: Identify and quantify the cost of the care pathway for patients with Parkinson's disease
time frame: Day 0
description: it is the quantification of the number of resources consumed and identification of the unit costs for each type of resources consumed.
measure: identify socio-economic determinants
time frame: Day 0
description: identify the socio-economic and territorial determinants that could have an impact on an optimal care path.
arm group label: Parkinson's disease patients
description: Parkinson's disease patients and over 18 years old
intervention type: Other
intervention name: Questionnaire
description: The patient answers the questionnaire directly following his consultation or teleconsultation or may arrange a telephone appointment with the clinical research associate a little later.
arm group label: Parkinson's disease patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Olivier Rascol
role: Principal Investigator
affiliation: University Hospital, Toulouse
facility: 
country: France
responsible party type: Sponsor
mesh term: Parkinson Disease
sharing ipd: No