<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/NCT03304977</url>
  </required_header>
  <id_info>
    <org_study_id>CACHACA</org_study_id>
    <nct_id>NCT03304977</nct_id>
  </id_info>
  <brief_title>Patient's Knowledge on Their Anticoagulating and Anti Platelet Treatment St Joseph's Hospital)</brief_title>
  <official_title>Current Situation of the Patient's Knowledge on Their Anticoagulating and Anti Platelet Treatment in GHPSJ (St Joseph's Hospital)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Hôpital Saint-Joseph</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondation Hôpital Saint-Joseph</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>
      Oral antigoagulant are used more than 60 years in thrombotic diseases. Even they are&#xD;
      indispensable, the haemorragic risk is high.That's why it's the main reason of&#xD;
      hospitalization for iatrogeny.The complication's reasons are mainly linked to errors of drug&#xD;
      intake, drugs interaction and the lack of understanding the treatment.Moreover, the&#xD;
      antiplatelet agglutening treatment is frequently added to anticoagulant treatment.This&#xD;
      increases the haemorragic risk.Different means were used to minimize the risk , like INR&#xD;
      follow up.&#xD;
&#xD;
      The purpose of the study is to evaluate smartphone use to follow the patients'treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Two questionnaire via smartphone with 15 days gap.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 6, 2016</start_date>
  <completion_date type="Actual">October 30, 2016</completion_date>
  <primary_completion_date type="Actual">July 31, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>smartphone use level</measure>
    <time_frame>15 days</time_frame>
    <description>evaluation of the interest of patient to use their smartphone in the purpose to follow their anticoagulant treatment</description>
  </primary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Coagulation Disorder</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>questionnaire via smartphone</intervention_name>
    <description>questionnaire via smartphone</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient under ant-thrombotic treatment&#xD;
&#xD;
          -  hospitalized in vascular medecine service&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refusing the participation&#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>Pascal PRIOLLET, MD</last_name>
    <role>Study Director</role>
    <affiliation>GHPSJ</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Groupe Hospitalier Paris Saint Joseph</name>
      <address>
        <city>Paris</city>
        <state>Ile-de-France</state>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 29, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>October 3, 2017</last_update_submitted>
  <last_update_submitted_qc>October 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2017</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>Hemostatic Disorders</mesh_term>
    <mesh_term>Blood Coagulation Disorders</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/NCT03304977
org study id: CACHACA
nct id: NCT03304977
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Oral antigoagulant are used more than 60 years in thrombotic diseases. Even they are
      indispensable, the haemorragic risk is high.That's why it's the main reason of
      hospitalization for iatrogeny.The complication's reasons are mainly linked to errors of drug
      intake, drugs interaction and the lack of understanding the treatment.Moreover, the
      antiplatelet agglutening treatment is frequently added to anticoagulant treatment.This
      increases the haemorragic risk.Different means were used to minimize the risk , like INR
      follow up.

      The purpose of the study is to evaluate smartphone use to follow the patients'treatment.
Two questionnaire via smartphone with 15 days gap.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: smartphone use level
time frame: 15 days
description: evaluation of the interest of patient to use their smartphone in the purpose to follow their anticoagulant treatment
intervention type: Other
intervention name: questionnaire via smartphone
description: questionnaire via smartphone
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pascal PRIOLLET, MD
role: Study Director
affiliation: GHPSJ
facility: 
country: France
responsible party type: Sponsor
mesh term: Hemostatic Disorders
mesh term: Blood Coagulation Disorders