<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/NCT02214056</url>
  </required_header>
  <id_info>
    <org_study_id>LOCAL/2013/DC-02</org_study_id>
    <secondary_id>2013-A01703-42</secondary_id>
    <nct_id>NCT02214056</nct_id>
  </id_info>
  <brief_title>Mobile Unit Screening of Pathologies Associated With Chronic Diseases - Feasibility</brief_title>
  <acronym>DéProPAss</acronym>
  <official_title>Mobile Unit Screening of Pathologies Associated With Chronic Diseases - Part I Feasibility</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nīmes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nīmes</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective of this study is to assess the feasibility of standardized screening for&#xD;
      comorbidities among patients with one or more of three chronic diseases (diabetes, COPD,&#xD;
      atherosclerosis) by a mobile unit at times and localities under-served by health actors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators secondary objectives include assessing patient and GP satisfaction in&#xD;
      relation to the mobile screening team.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2015</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</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>Percentage of eligible patients who actually received the mobile team exam</measure>
    <time_frame>Day of mobile team exam (day 0)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Observance: percentage of patients included that actually received the balance sheet</measure>
    <time_frame>Day of mobile team exam (day 0)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time in days between making the appointment by the general practitioner and the mobile team exam</measure>
    <time_frame>Day of mobile team exam (day 0)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average per patient time necessary to carry out the mobile team exam</measure>
    <time_frame>Day of mobile team exam (day 0)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average time required for the patient to fill out questionnaires</measure>
    <time_frame>Day of mobile team exam (day 0)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of complete mobile team exams, that is to say in which all the data and all the variables have been collected and interpreted</measure>
    <time_frame>Day of mobile team exam (day 0)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of GPs who participated in the study</measure>
    <time_frame>Day of mobile team exam (day 0)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of mobile team exams in which one or more comorbidities was discovered</measure>
    <time_frame>Day of mobile team exam (day 0)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GP and patient acceptability of the mobile team exam</measure>
    <time_frame>Day of mobile team exam (day 0)</time_frame>
    <description>Visual analog scales (ranging from 0 to 10) for access, delays, organization and satisfaction.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">27</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <condition>Type II Diabetes</condition>
  <condition>Atherosclerosis</condition>
  <arm_group>
    <arm_group_label>The study population</arm_group_label>
    <description>There is only one group in this study. Please see the inclusion/exclusion criteria.&#xD;
Intervention: Patient recruitment Intervention: Mobile team exam</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patient recruitment</intervention_name>
    <description>Participating general practitioners (GPs) will inform and recruit participants from among regular patient consults. Using the provided web tools, GPs will organize a visit with the mobile team that fits the needs of the patient.</description>
    <arm_group_label>The study population</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Mobile team exam</intervention_name>
    <description>Each patient enrolled will receive a standardized assessment in one locality, made in about two hours, and comprising:&#xD;
questionnaire responses, a complete physical exam, a 12-lead ECG, spirometry before and after administration of β2-agonists, an arterial Doppler ultrasound (carotid and abdominal), ankle-brachial index (systolic pressure at the toe).&#xD;
At the end of two hours, each patient will evaluate their satisfaction using a survey of acceptability and leave with a full report to the attention of their general practitioner (copy sent to Physician if needed) detailing the results of the different examinations.</description>
    <arm_group_label>The study population</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population consists of patients at least 50 years of age with a chronic disease&#xD;
        (COPD, Type II diabetes, atherosclerosis) recruited by one of the GP investigators.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient must have given his/her informed and signed consent&#xD;
&#xD;
          -  The patient must be insured or beneficiary of a health insurance plan&#xD;
&#xD;
          -  The patient has one or more of the following three diseases: (1) chronic obstructive&#xD;
             pulmonary disease (COPD); (2) type II diabetes; (3) atherosclerosis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patient is participating in another study&#xD;
&#xD;
          -  The patient is in an exclusion period determined by a previous study&#xD;
&#xD;
          -  The patient is under judicial protection, under tutorship or curatorship&#xD;
&#xD;
          -  The patient refuses to sign the consent&#xD;
&#xD;
          -  It is impossible to correctly inform the patient&#xD;
&#xD;
          -  There is a need to take urgent therapeutic care in the opinion of the general&#xD;
             practitioner&#xD;
&#xD;
          -  The patient has received within the past year, a full examination including Doppler&#xD;
             assessment of supra-aortic arteries, abdominal aorta and lower limbs; the patient has&#xD;
             received a measure of the ankle-brachial index at the toe.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Costa, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Universitaire de Nîmes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cabinet Médical - 47 rue de la République</name>
      <address>
        <city>Besseges</city>
        <zip>30160</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre de Santé Médical</name>
      <address>
        <city>Besseges</city>
        <zip>30160</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre médical des Olivettes</name>
      <address>
        <city>Ganges</city>
        <zip>34190</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cabinet Médical - 5 rue Abbé Masson</name>
      <address>
        <city>La Grand Combe</city>
        <zip>30110</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cabinet Médical - 154 Place de la Poste</name>
      <address>
        <city>Lasalle</city>
        <zip>30460</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cabinet Médical - Les Glycines</name>
      <address>
        <city>Lasalle</city>
        <zip>30460</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cabinet Médical - Pont de Grammal</name>
      <address>
        <city>Molières-sur-Cèze</city>
        <zip>30410</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cabinet Médical - 9 rue Racine</name>
      <address>
        <city>Nîmes</city>
        <zip>30000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cabinet Médical - 15 rue du Lac</name>
      <address>
        <city>Quissac</city>
        <zip>30260</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cabinet Médical - 7 bis avenue Rhin Danube</name>
      <address>
        <city>Sauve</city>
        <zip>30610</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cabinet Médical - 36 place de l'Esplanade</name>
      <address>
        <city>St Ambroix</city>
        <zip>30500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Médical La Cantonnade</name>
      <address>
        <city>St Florent sur Auzonnet</city>
        <zip>30960</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cabinét Médical - 9 rue Villeneuve</name>
      <address>
        <city>St Jean du Gard</city>
        <zip>30270</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>May 5, 2015</last_update_submitted>
  <last_update_submitted_qc>May 5, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 6, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mobile screening team</keyword>
  <keyword>feasibility</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    <mesh_term>Atherosclerosis</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Chronic Disease</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/NCT02214056
org study id: LOCAL/2013/DC-02
secondary id: 2013-A01703-42
nct id: NCT02214056
lead sponsor: 
has dmc: No
The main objective of this study is to assess the feasibility of standardized screening for
      comorbidities among patients with one or more of three chronic diseases (diabetes, COPD,
      atherosclerosis) by a mobile unit at times and localities under-served by health actors.
The investigators secondary objectives include assessing patient and GP satisfaction in
      relation to the mobile screening team.
observational model: Cohort
time perspective: Prospective
measure: Percentage of eligible patients who actually received the mobile team exam
time frame: Day of mobile team exam (day 0)
measure: Observance: percentage of patients included that actually received the balance sheet
time frame: Day of mobile team exam (day 0)
measure: Time in days between making the appointment by the general practitioner and the mobile team exam
time frame: Day of mobile team exam (day 0)
measure: Average per patient time necessary to carry out the mobile team exam
time frame: Day of mobile team exam (day 0)
measure: Average time required for the patient to fill out questionnaires
time frame: Day of mobile team exam (day 0)
measure: Percentage of complete mobile team exams, that is to say in which all the data and all the variables have been collected and interpreted
time frame: Day of mobile team exam (day 0)
measure: Percentage of GPs who participated in the study
time frame: Day of mobile team exam (day 0)
measure: Percentage of mobile team exams in which one or more comorbidities was discovered
time frame: Day of mobile team exam (day 0)
measure: GP and patient acceptability of the mobile team exam
time frame: Day of mobile team exam (day 0)
description: Visual analog scales (ranging from 0 to 10) for access, delays, organization and satisfaction.
arm group label: The study population
description: There is only one group in this study. Please see the inclusion/exclusion criteria.
Intervention: Patient recruitment Intervention: Mobile team exam
intervention type: Other
intervention name: Patient recruitment
description: Participating general practitioners (GPs) will inform and recruit participants from among regular patient consults. Using the provided web tools, GPs will organize a visit with the mobile team that fits the needs of the patient.
arm group label: The study population
intervention type: Procedure
intervention name: Mobile team exam
description: Each patient enrolled will receive a standardized assessment in one locality, made in about two hours, and comprising:
questionnaire responses, a complete physical exam, a 12-lead ECG, spirometry before and after administration of β2-agonists, an arterial Doppler ultrasound (carotid and abdominal), ankle-brachial index (systolic pressure at the toe).
At the end of two hours, each patient will evaluate their satisfaction using a survey of acceptability and leave with a full report to the attention of their general practitioner (copy sent to Physician if needed) detailing the results of the different examinations.
arm group label: The study population
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: David Costa, MD
role: Principal Investigator
affiliation: Centre Hospitalier Universitaire de Nîmes
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Atherosclerosis
mesh term: Diabetes Mellitus, Type 2
mesh term: Chronic Disease