<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/NCT04499846</url>
  </required_header>
  <id_info>
    <org_study_id>RC-P0096</org_study_id>
    <secondary_id>2020-A00402-37</secondary_id>
    <nct_id>NCT04499846</nct_id>
  </id_info>
  <brief_title>Educational Intervention Targeting Statin Therapy and Compliance in Diabetic Patients</brief_title>
  <acronym>STADIA</acronym>
  <official_title>Can Educational Intervention Targeting Statin Therapy Improve Compliance in Diabetic Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lille Catholic University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lille Catholic University</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>
      The objective of the study is to measure changes in compliance to statin therapy in patients&#xD;
      with type 2 diabetes after an educational intervention. This intervention is part of the&#xD;
      therapeutic education of the diabetic patient, carried out throughout the follow-up of&#xD;
      his/her diabetes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 11, 2020</start_date>
  <completion_date type="Actual">May 7, 2021</completion_date>
  <primary_completion_date type="Actual">May 7, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Compliance rate to the statin treatment</measure>
    <time_frame>3 months</time_frame>
    <description>Compliance is estimated with the compliance evaluation Test of Girerd based on a score from 0 to 6. Six questions are asked to the patient.&#xD;
For the interpretation of the test:&#xD;
Total YES = 0, Score = 0: Good compliance Total YES = 1 or 2, Score = 1 or 2: Minimal compliance Total YES ≥ 3, Score ≥ 3: Poor compliance Lack of completion of the questionnaire is considered as &quot;poor compliance&quot;.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compliance rate to the statin treatment according to schedule of drug intake</measure>
    <time_frame>3 months</time_frame>
    <description>Compliance is estimated with the compliance evaluation Test of Girerd based on a score from 0 to 6. Six questions are asked to the patient.&#xD;
For the interpretation of the test:&#xD;
Total YES = 0, Score = 0: Good compliance Total YES = 1 or 2, Score = 1 or 2: Minimal compliance Total YES ≥ 3, Score ≥ 3: Poor compliance Lack of completion of the questionnaire is considered as &quot;poor compliance&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance rate to the statin treatment according to treatment duration.</measure>
    <time_frame>3 months</time_frame>
    <description>Compliance is estimated with the compliance evaluation Test of Girerd based on a score from 0 to 6. Six questions are asked to the patient.&#xD;
For the interpretation of the test:&#xD;
Total YES = 0, Score = 0: Good compliance Total YES = 1 or 2, Score = 1 or 2: Minimal compliance Total YES ≥ 3, Score ≥ 3: Poor compliance Lack of completion of the questionnaire is considered as &quot;poor compliance&quot;.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">96</enrollment>
  <condition>Type II Diabetes</condition>
  <arm_group>
    <arm_group_label>Diabetic patients following education</arm_group_label>
    <description>Patients will followed an educational intervention about physiopathology of diabetes and mechanisms of action of statins. A questionnaire will allow to measure compliance to the treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Therapeutic education</intervention_name>
    <description>Patients will follow a therapeutic education in order to inform them about the mechanism of action of statins. After this intervention a questionnaire will use to measure compliance.</description>
    <arm_group_label>Diabetic patients following education</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Diabetic patients hospitalized in the diabetes day hospitals of the Saint Philibert or&#xD;
        Saint-Vincent hospitals (Lille, France)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years old or more&#xD;
&#xD;
          -  Type 2 diabetes&#xD;
&#xD;
          -  Following treatment with statins&#xD;
&#xD;
          -  Hospitalization in the diabetes day hospitals of the Saint Philibert or Saint Vincent&#xD;
             Hospitals (Lille, France).&#xD;
&#xD;
          -  Ability to answer the Girerd test in both interviews (in the individual interview and&#xD;
             by phone)&#xD;
&#xD;
          -  Patient informed to participate in the study&#xD;
&#xD;
          -  Signed patient's consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under guardianship&#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>François Delecourt, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>GHICL</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Saint-philibert</name>
      <address>
        <city>Lomme</city>
        <state>Nord Pas De Calais</state>
        <zip>59462</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>October 12, 2021</last_update_submitted>
  <last_update_submitted_qc>October 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diabetes</keyword>
  <keyword>Compliance</keyword>
  <keyword>Statin</keyword>
  <keyword>Education</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</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/NCT04499846
org study id: RC-P0096
secondary id: 2020-A00402-37
nct id: NCT04499846
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of the study is to measure changes in compliance to statin therapy in patients
      with type 2 diabetes after an educational intervention. This intervention is part of the
      therapeutic education of the diabetic patient, carried out throughout the follow-up of
      his/her diabetes.
observational model: Case-Only
time perspective: Prospective
measure: Compliance rate to the statin treatment
time frame: 3 months
description: Compliance is estimated with the compliance evaluation Test of Girerd based on a score from 0 to 6. Six questions are asked to the patient.
For the interpretation of the test:
Total YES = 0, Score = 0: Good compliance Total YES = 1 or 2, Score = 1 or 2: Minimal compliance Total YES ≥ 3, Score ≥ 3: Poor compliance Lack of completion of the questionnaire is considered as "poor compliance".
measure: Compliance rate to the statin treatment according to schedule of drug intake
time frame: 3 months
description: Compliance is estimated with the compliance evaluation Test of Girerd based on a score from 0 to 6. Six questions are asked to the patient.
For the interpretation of the test:
Total YES = 0, Score = 0: Good compliance Total YES = 1 or 2, Score = 1 or 2: Minimal compliance Total YES ≥ 3, Score ≥ 3: Poor compliance Lack of completion of the questionnaire is considered as "poor compliance".
measure: Compliance rate to the statin treatment according to treatment duration.
time frame: 3 months
description: Compliance is estimated with the compliance evaluation Test of Girerd based on a score from 0 to 6. Six questions are asked to the patient.
For the interpretation of the test:
Total YES = 0, Score = 0: Good compliance Total YES = 1 or 2, Score = 1 or 2: Minimal compliance Total YES ≥ 3, Score ≥ 3: Poor compliance Lack of completion of the questionnaire is considered as "poor compliance".
arm group label: Diabetic patients following education
description: Patients will followed an educational intervention about physiopathology of diabetes and mechanisms of action of statins. A questionnaire will allow to measure compliance to the treatment.
intervention type: Other
intervention name: Therapeutic education
description: Patients will follow a therapeutic education in order to inform them about the mechanism of action of statins. After this intervention a questionnaire will use to measure compliance.
arm group label: Diabetic patients following education
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: François Delecourt, MD
role: Principal Investigator
affiliation: GHICL
facility: 
country: France
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No