<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/NCT01728714</url>
  </required_header>
  <id_info>
    <org_study_id>NIS-CPO-XXX-2012/1</org_study_id>
    <secondary_id>CV/No drug/NIS-CPO-XXX-2012/1</secondary_id>
    <nct_id>NCT01728714</nct_id>
  </id_info>
  <brief_title>Better Diabetes Control, Quality - Educate to Achieve Compliance.</brief_title>
  <acronym>MINERVA</acronym>
  <official_title>Prospective Study to Evaluate Impact of an Educational Programme About Diabetes, Comparing to Normal Clinical Practice, on Treatment Compliance and Disease Control of People With Type 2 Diabetes Followed in Primary Care Units in Portugal</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective study to evaluate the impact of an educational programme about diabetes,&#xD;
      comparing to normal clinical practice, on treatment compliance and disease control of people&#xD;
      with type 2 diabetes followed in the primary care units in Portugal&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective study to evaluate the impact of an educational programme about diabetes focusing&#xD;
      on treatment compliance, exercise and nutrition, comparing to normal clinical practice, on&#xD;
      treatment compliance and disease control of people with type 2 diabetes followed in the&#xD;
      primary care units in Portugal.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 19, 2014</start_date>
  <completion_date type="Actual">December 5, 2018</completion_date>
  <primary_completion_date type="Actual">December 5, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of people with type 2 diabetes treated with oral antidiabetics assessed as compliant with treatment after 1 year educational programme on diabetes, compared with normal clinical practice.</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of people with type 2 diabetes treated with oral antidiabetics assessed as compliant with diet and physical exercise after 1 year educational programme on diabetes, compared with normal clinical practice.</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of people with type 2 diabetes treated with oral antidiabetics assessed as compliant with treatment with oral antidiabetics;after 1 year educational programme on diabetes, compared with normal clinical practice.</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure impact on quality of life, perceived by the patient, following 1 year educational programme on diabetes, compared with normal clinical practice.</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure the impact of compliance with treatment on glucose control following 1 year educational programme on diabetes, compared with normal clinical practice.</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure level of satisfaction of the patient with treatment and medical care following 1 year educational programme on diabetes, compared with normal clinical practice.</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">227</enrollment>
  <condition>Diabetes Type 2</condition>
  <arm_group>
    <arm_group_label>Adults over 18 years old</arm_group_label>
    <description>Adults over 18 years old, with type 2 diabetes, HbA1c &lt;= 8,5%, treated with oral antidiabetics at least for 6 months submitted to an educational programme during 1 year</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adults with HbA1c &lt;= 8,5%</arm_group_label>
    <description>Adults over 18 years old, with type 2 diabetes, HbA1c &lt;= 8,5%, treated with oral antidiabetics at least for 6 months followed according to normal clinical practice during 1 year</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        primary care setting patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals with type 2 diabetes&#xD;
&#xD;
          -  HbA1c &lt;= 8,5%&#xD;
&#xD;
          -  Treated with oral antidiabetics for at least 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Treatment with insulin&#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>Cláudia Antão</last_name>
    <role>Principal Investigator</role>
    <affiliation>Research Site 01</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pedro Carriço</last_name>
    <role>Principal Investigator</role>
    <affiliation>Research site 02</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Carla Gouveia</last_name>
    <role>Principal Investigator</role>
    <affiliation>Research site 03</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jorge Vinagre</last_name>
    <role>Principal Investigator</role>
    <affiliation>Research site 04</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Almada</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Espinho</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Loures</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Oeiras</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Santo Antonio Dos Cavaleiros</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>November 14, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>February 5, 2019</last_update_submitted>
  <last_update_submitted_qc>February 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diabetes; compliance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</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/NCT01728714
org study id: NIS-CPO-XXX-2012/1
secondary id: CV/No drug/NIS-CPO-XXX-2012/1
nct id: NCT01728714
lead sponsor: 
has dmc: No
Prospective study to evaluate the impact of an educational programme about diabetes,
      comparing to normal clinical practice, on treatment compliance and disease control of people
      with type 2 diabetes followed in the primary care units in Portugal
Prospective study to evaluate the impact of an educational programme about diabetes focusing
      on treatment compliance, exercise and nutrition, comparing to normal clinical practice, on
      treatment compliance and disease control of people with type 2 diabetes followed in the
      primary care units in Portugal.
observational model: Case-Control
time perspective: Prospective
measure: Number of people with type 2 diabetes treated with oral antidiabetics assessed as compliant with treatment after 1 year educational programme on diabetes, compared with normal clinical practice.
time frame: 1 year
measure: Number of people with type 2 diabetes treated with oral antidiabetics assessed as compliant with diet and physical exercise after 1 year educational programme on diabetes, compared with normal clinical practice.
time frame: 1 year
measure: Number of people with type 2 diabetes treated with oral antidiabetics assessed as compliant with treatment with oral antidiabetics;after 1 year educational programme on diabetes, compared with normal clinical practice.
time frame: 1 year
measure: Measure impact on quality of life, perceived by the patient, following 1 year educational programme on diabetes, compared with normal clinical practice.
time frame: 1 year
measure: Measure the impact of compliance with treatment on glucose control following 1 year educational programme on diabetes, compared with normal clinical practice.
time frame: 1 year
measure: Measure level of satisfaction of the patient with treatment and medical care following 1 year educational programme on diabetes, compared with normal clinical practice.
time frame: 1 year
arm group label: Adults over 18 years old
description: Adults over 18 years old, with type 2 diabetes, HbA1c <= 8,5%, treated with oral antidiabetics at least for 6 months submitted to an educational programme during 1 year
arm group label: Adults with HbA1c <= 8,5%
description: Adults over 18 years old, with type 2 diabetes, HbA1c <= 8,5%, treated with oral antidiabetics at least for 6 months followed according to normal clinical practice during 1 year
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Cláudia Antão
role: Principal Investigator
affiliation: Research Site 01
last name: Pedro Carriço
role: Principal Investigator
affiliation: Research site 02
last name: Carla Gouveia
role: Principal Investigator
affiliation: Research site 03
last name: Jorge Vinagre
role: Principal Investigator
affiliation: Research site 04
facility: 
facility: 
facility: 
facility: 
facility: 
country: Portugal
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2