<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/NCT01669681</url>
  </required_header>
  <id_info>
    <org_study_id>8871</org_study_id>
    <secondary_id>2011-A0156-35</secondary_id>
    <nct_id>NCT01669681</nct_id>
  </id_info>
  <brief_title>Cobra (Severe Asthma)Medical-economic</brief_title>
  <acronym>Cobra</acronym>
  <official_title>Medical Economic Evaluation of the Care of the Severe Asthma : Cohort COBRA</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The severe asthma is a major source of expenses in term of public health, while it concerns&#xD;
      no more than 5 % of the asthmatics. The expenses is direct (medicines, hospitalizations,&#xD;
      care) but especially indirect (absenteeisms, etc.). The forward-looking follow-up of cohort&#xD;
      of more than 500 severe asthmatic patients multicentrique in an already widely established&#xD;
      cohort (COBRA, at present in Visit 9 (one every 6 months) is an once-in-a-lifetime&#xD;
      opportunity, coupled with the data of the CPAM, to identify well the evolution in time of a&#xD;
      real medical economic variable. The possibility of dynamic follow-up of the expenses compared&#xD;
      to the medical data offers perspectives of evaluation cost-efficiency of the informed&#xD;
      therapeutic procedures. It is possible to couple in a forward-looking and dynamic way the&#xD;
      data of health stemming from a cohort with the economic data stemming from the CPAM. This&#xD;
      variable included in a Cluster's algorithm has to allow to identify the interventions the&#xD;
      more and the less cost effective. The main objective of this study is to realize a cost&#xD;
      estimate of care of the severe asthma. The variation of the costs will be also studied. The&#xD;
      recruited patients are patients already included in the cohort COBRA in the centers of&#xD;
      Marseille, Montpelier or Nice, classified GINA 4 and agreeing to participate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The following direct medical costs will be collected according to the point of view of the&#xD;
      Social Security on a duration of 2 years:&#xD;
&#xD;
        -  Hospitalizations (valuation from the GHS + medicines except GHS)· Consultations&#xD;
           (valuation AM)&#xD;
&#xD;
        -  Complementary(additional) examinations except hospitalization (valuation AM)&#xD;
&#xD;
        -  Pharmacy (valuation AM)&#xD;
&#xD;
        -  Transport (valuation AM)The estimate of average costs will be made with a reliable&#xD;
           interval for 95 %.&#xD;
&#xD;
      The average cost by patient of the care will be calculated for every year of the follow-up.&#xD;
      Relationship individual cost-efficiency: by analogy with the studies cost-efficiency&#xD;
      comparative clauses, the investigators shall calculate a relationship cost-efficiency at the&#xD;
      individual level as follows: (cost-year2 - cost-year1) / (efficiency-year2 - efficiency-year&#xD;
      1). Differences in these relationships will be looked for between various groups by tests of&#xD;
      comparisons of averages.The construction of patients' clusters will be made according to the&#xD;
      algorithm of the study SARP but also by using techniques statistics of classification non&#xD;
      supervising to define our own algorithm. Variables used on our algorithm will include the&#xD;
      relationship cost efficiency individual in addition to the clinical variables. The temporal&#xD;
      stability of the relationship cost efficiency will be analyzed. The risk factors of a&#xD;
      modification of this relationship will be looked for.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 20, 2011</start_date>
  <completion_date type="Actual">December 16, 2016</completion_date>
  <primary_completion_date type="Actual">December 16, 2014</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 costs will be updated at the rate recommended by the College of the Economists of the Health. For every year of follow-up will be calculated the individual costs and the annual average cost</measure>
    <time_frame>Baseline</time_frame>
    <description>The costs will be updated at the rate recommended by the College of the Economists of the Health. For every year of follow-up will be calculated the individual costs and the annual average cost (with a reliable interval in 95 %).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The clinical data will allow to measure the efficiency (control, exacerbation, hospitalization, composite score integrating these various variables).</measure>
    <time_frame>Baseline</time_frame>
    <description>The clinical data will allow to measure the efficiency (control, exacerbation, hospitalization, composite score integrating these various variables).&#xD;
The relationship cost efficiency can so be calculated for two years for which we shall have the data.&#xD;
The utility will be measured by means of the validated questionnaire EQ 5D.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">81</enrollment>
  <condition>Allergic Asthma</condition>
  <arm_group>
    <arm_group_label>Included in the cohort COBRA</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The recruited patients are patients already included in the observationnelle cohort COBRA&#xD;
        in the centers of Marseille, Montpelier or Nice, classified GINA 4 and agreeing to&#xD;
        participate.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients included in the observationnal cohort COBRA for at least 6 months&#xD;
&#xD;
          -  Patient members in one of the partner health insurance funds&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patient refusing his participation to the research&#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>Nicolas MOLINARI</last_name>
    <role>Principal Investigator</role>
    <affiliation>Montpellier University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Montpellier University Hospital</name>
      <address>
        <city>Montpellier</city>
        <zip>34090</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>April 3, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <last_update_submitted>April 6, 2017</last_update_submitted>
  <last_update_submitted_qc>April 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Severe asthma</keyword>
  <keyword>Medical economic</keyword>
  <keyword>care</keyword>
  <keyword>Cost efficiency</keyword>
  <keyword>CPAM</keyword>
  <keyword>EQ5D</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <!-- 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/NCT01669681
org study id: 8871
secondary id: 2011-A0156-35
nct id: NCT01669681
lead sponsor: 
has dmc: Yes
The severe asthma is a major source of expenses in term of public health, while it concerns
      no more than 5 % of the asthmatics. The expenses is direct (medicines, hospitalizations,
      care) but especially indirect (absenteeisms, etc.). The forward-looking follow-up of cohort
      of more than 500 severe asthmatic patients multicentrique in an already widely established
      cohort (COBRA, at present in Visit 9 (one every 6 months) is an once-in-a-lifetime
      opportunity, coupled with the data of the CPAM, to identify well the evolution in time of a
      real medical economic variable. The possibility of dynamic follow-up of the expenses compared
      to the medical data offers perspectives of evaluation cost-efficiency of the informed
      therapeutic procedures. It is possible to couple in a forward-looking and dynamic way the
      data of health stemming from a cohort with the economic data stemming from the CPAM. This
      variable included in a Cluster's algorithm has to allow to identify the interventions the
      more and the less cost effective. The main objective of this study is to realize a cost
      estimate of care of the severe asthma. The variation of the costs will be also studied. The
      recruited patients are patients already included in the cohort COBRA in the centers of
      Marseille, Montpelier or Nice, classified GINA 4 and agreeing to participate.
The following direct medical costs will be collected according to the point of view of the
      Social Security on a duration of 2 years:

        -  Hospitalizations (valuation from the GHS + medicines except GHS)· Consultations
           (valuation AM)

        -  Complementary(additional) examinations except hospitalization (valuation AM)

        -  Pharmacy (valuation AM)

        -  Transport (valuation AM)The estimate of average costs will be made with a reliable
           interval for 95 %.

      The average cost by patient of the care will be calculated for every year of the follow-up.
      Relationship individual cost-efficiency: by analogy with the studies cost-efficiency
      comparative clauses, the investigators shall calculate a relationship cost-efficiency at the
      individual level as follows: (cost-year2 - cost-year1) / (efficiency-year2 - efficiency-year
      1). Differences in these relationships will be looked for between various groups by tests of
      comparisons of averages.The construction of patients' clusters will be made according to the
      algorithm of the study SARP but also by using techniques statistics of classification non
      supervising to define our own algorithm. Variables used on our algorithm will include the
      relationship cost efficiency individual in addition to the clinical variables. The temporal
      stability of the relationship cost efficiency will be analyzed. The risk factors of a
      modification of this relationship will be looked for.
observational model: Cohort
time perspective: Prospective
measure: The costs will be updated at the rate recommended by the College of the Economists of the Health. For every year of follow-up will be calculated the individual costs and the annual average cost
time frame: Baseline
description: The costs will be updated at the rate recommended by the College of the Economists of the Health. For every year of follow-up will be calculated the individual costs and the annual average cost (with a reliable interval in 95 %).
measure: The clinical data will allow to measure the efficiency (control, exacerbation, hospitalization, composite score integrating these various variables).
time frame: Baseline
description: The clinical data will allow to measure the efficiency (control, exacerbation, hospitalization, composite score integrating these various variables).
The relationship cost efficiency can so be calculated for two years for which we shall have the data.
The utility will be measured by means of the validated questionnaire EQ 5D.
arm group label: Included in the cohort COBRA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nicolas MOLINARI
role: Principal Investigator
affiliation: Montpellier University Hospital
facility: 
country: France
responsible party type: Sponsor
mesh term: Asthma