<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/NCT03286790</url>
  </required_header>
  <id_info>
    <org_study_id>11 280 03</org_study_id>
    <nct_id>NCT03286790</nct_id>
  </id_info>
  <brief_title>Incidence of pNeumonia and Related ConseqUences in Nursing Home Residents</brief_title>
  <acronym>INCUR</acronym>
  <official_title>Incidence of pNeumonia and Related ConseqUences in Nursing Home</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>
      In the present proposal, we hypothesize that specifically targeting pneumonia events with&#xD;
      preventive interventions in the French EHPAD (Etablissements d'Hébergement pour Personnes&#xD;
      Agées Dépendantes) setting (thus, improving the health status and quality of life of&#xD;
      patients) may simultaneously produce relevant reductions in the healthcare costs. In fact,&#xD;
      although the number of pneumonia cases may be numerically limited, the consequences of each&#xD;
      event are potentially catastrophic for both the patient and the healthcare system.&#xD;
      Unfortunately, to date, information about the incidence and economical effects of pneumonia&#xD;
      in the older population living in the French EHPAD are extremely scare. To adequately&#xD;
      evaluate whether there is room to implement preventive interventions aimed at reducing the&#xD;
      onset of pneumonia in a cost-effective fashion on a large scale, preliminary data from this&#xD;
      specific population are needed. This first step is crucial towards the appropriate design and&#xD;
      conduction of possible future large-scale intervention trials in the EHPAD setting.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2012</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</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>Incidence of pneumonia</measure>
    <time_frame>months 12</time_frame>
    <description>Estimate the incidence of pneumonia events in a sample of 800 older patients living in 30 EHPADs over a period of 12 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>healthcare costs</measure>
    <time_frame>months 12</time_frame>
    <description>To compare the healthcare costs of participants experiencing a pneumonia event versus those who will not in a random sample of 800 older patients living in 30 EHPADs over a period of 12 month</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality risk</measure>
    <time_frame>Months 12</time_frame>
    <description>To calculate the mortality risk in a random sample of 800 EHPAD older patients according to the presence/absence of a pneumonia event occurred during a follow-up period of 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Function</measure>
    <time_frame>Months 12</time_frame>
    <description>To measure the physical function modifications experienced by a random sample of 800 EHPAD older patients according to the presence/absence of a pneumonia event occurred during a follow-up period of 12 months</description>
  </secondary_outcome>
  <enrollment type="Actual">800</enrollment>
  <condition>Pneumonia</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Data collection on pneumonia events</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients living in the participating EHPAD for more than 30 days since the baseline study&#xD;
        visit&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Groups Iso-Resources (GIR) ranging between 5 (included) and 2 (included)&#xD;
&#xD;
          -  Ability and willingness to participate to the study and to provide informed consent&#xD;
&#xD;
          -  Agreement with the patient's physician about the enrolment to the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal of the EHPAD to participate&#xD;
&#xD;
          -  Patients with severe disability (GIR 1)&#xD;
&#xD;
          -  Patients with no evidence of functional impairment (GIR 6)&#xD;
&#xD;
          -  Patients living in the participating EHPAD for less than 30 days since the baseline&#xD;
             study visit&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mateo Cesari, MD</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital, Toulouse</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Toulouse</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>September 14, 2017</last_update_submitted>
  <last_update_submitted_qc>September 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>elderly</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</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/NCT03286790
org study id: 11 280 03
nct id: NCT03286790
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In the present proposal, we hypothesize that specifically targeting pneumonia events with
      preventive interventions in the French EHPAD (Etablissements d'Hébergement pour Personnes
      Agées Dépendantes) setting (thus, improving the health status and quality of life of
      patients) may simultaneously produce relevant reductions in the healthcare costs. In fact,
      although the number of pneumonia cases may be numerically limited, the consequences of each
      event are potentially catastrophic for both the patient and the healthcare system.
      Unfortunately, to date, information about the incidence and economical effects of pneumonia
      in the older population living in the French EHPAD are extremely scare. To adequately
      evaluate whether there is room to implement preventive interventions aimed at reducing the
      onset of pneumonia in a cost-effective fashion on a large scale, preliminary data from this
      specific population are needed. This first step is crucial towards the appropriate design and
      conduction of possible future large-scale intervention trials in the EHPAD setting.
observational model: Cohort
time perspective: Prospective
measure: Incidence of pneumonia
time frame: months 12
description: Estimate the incidence of pneumonia events in a sample of 800 older patients living in 30 EHPADs over a period of 12 months
measure: healthcare costs
time frame: months 12
description: To compare the healthcare costs of participants experiencing a pneumonia event versus those who will not in a random sample of 800 older patients living in 30 EHPADs over a period of 12 month
measure: Mortality risk
time frame: Months 12
description: To calculate the mortality risk in a random sample of 800 EHPAD older patients according to the presence/absence of a pneumonia event occurred during a follow-up period of 12 months
measure: Physical Function
time frame: Months 12
description: To measure the physical function modifications experienced by a random sample of 800 EHPAD older patients according to the presence/absence of a pneumonia event occurred during a follow-up period of 12 months
intervention type: Other
intervention name: Data collection on pneumonia events
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Mateo Cesari, MD
role: Study Director
affiliation: University Hospital, Toulouse
facility: 
country: France
responsible party type: Sponsor
mesh term: Pneumonia
sharing ipd: No