<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/NCT02988479</url>
  </required_header>
  <id_info>
    <org_study_id>9638</org_study_id>
    <nct_id>NCT02988479</nct_id>
  </id_info>
  <brief_title>Out-of Pocket Payments in Patients With Lymphedema</brief_title>
  <acronym>Lymphorac2</acronym>
  <official_title>Out-of Pocket Payments in Patients With Primary Lymphedema in France and Inequities of Access to Healthcare</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary lymphedema is a chronic condition posing a high burden on patients. Clinical&#xD;
      guidelines emphasize the role of compression therapy by prescription medical devices. Even in&#xD;
      a mandatory publicly funded health insurance system, out-of-pocket payments (OOPP) may exist&#xD;
      due to the price and reimbursement setting processes. OOPP may threaten the equity of care&#xD;
      and drive patients to forgo care. The investigators aim was to analyze the distributive&#xD;
      effects of OOPP for primary lymphedema patients in France.&#xD;
&#xD;
      A prospective, multicenter study will be conducted in France in 2015 on patients with primary&#xD;
      lymphedema. Household ability to pay will be specified by net income and OOPP will be&#xD;
      assessed prospectively over 6 months for outpatient care (visits, drugs, medical devices,&#xD;
      nursing care, biological tests, imaging, physiotherapy and transportations). Both mandatory&#xD;
      and voluntary health insurance reimbursements will be considered. The investigators will&#xD;
      combine concentration curves and concentration indices to assess the distributive effects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2016</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">October 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The mean monthly out-of-pocket payment as assessed by an online self-questionnaire</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <enrollment type="Actual">108</enrollment>
  <condition>Primary Lymphedema</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Out of pocket payments in patients</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All consecutive patients meeting the inclusion criteria will be included in each&#xD;
        participating centre during the inclusion phase&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Patient aged over six years, with primary lymphedema, regardless of the severity of&#xD;
             the disease;&#xD;
&#xD;
          -  Patient treated in one of the centres participating in the study;&#xD;
&#xD;
          -  Patient (and her legal representative for minors) who gave her written consent [or did&#xD;
             not refuse to participate, according to local Law];&#xD;
&#xD;
          -  Patient with Internet access and an active email address.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Patients with concomitant chronic venous insufficiency;&#xD;
&#xD;
          -  Patient not covered by any health care insurance scheme;&#xD;
&#xD;
          -  People protected under the law.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gregoire MERCIER, MD, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>September 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>February 26, 2019</last_update_submitted>
  <last_update_submitted_qc>February 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphedema</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/NCT02988479
org study id: 9638
nct id: NCT02988479
lead sponsor: 
has dmc: No
Primary lymphedema is a chronic condition posing a high burden on patients. Clinical
      guidelines emphasize the role of compression therapy by prescription medical devices. Even in
      a mandatory publicly funded health insurance system, out-of-pocket payments (OOPP) may exist
      due to the price and reimbursement setting processes. OOPP may threaten the equity of care
      and drive patients to forgo care. The investigators aim was to analyze the distributive
      effects of OOPP for primary lymphedema patients in France.

      A prospective, multicenter study will be conducted in France in 2015 on patients with primary
      lymphedema. Household ability to pay will be specified by net income and OOPP will be
      assessed prospectively over 6 months for outpatient care (visits, drugs, medical devices,
      nursing care, biological tests, imaging, physiotherapy and transportations). Both mandatory
      and voluntary health insurance reimbursements will be considered. The investigators will
      combine concentration curves and concentration indices to assess the distributive effects.
observational model: Cohort
time perspective: Prospective
measure: The mean monthly out-of-pocket payment as assessed by an online self-questionnaire
time frame: 6 months
intervention type: Other
intervention name: Out of pocket payments in patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 80 Years
healthy volunteers: No
last name: Gregoire MERCIER, MD, PHD
role: Principal Investigator
affiliation: University Hospital, Montpellier
facility: 
country: France
responsible party type: Sponsor
mesh term: Lymphedema
sharing ipd: No