<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/NCT04403841</url>
  </required_header>
  <id_info>
    <org_study_id>HMU16227</org_study_id>
    <nct_id>NCT04403841</nct_id>
  </id_info>
  <brief_title>Effect of Group Patient Education on Glycemic Control Among People Living With Type 2 Diabetes in Vietnam</brief_title>
  <official_title>Effect of Group Patient Education on Glycemic Control Among People Living With Type 2 Diabetes in Vietnam: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hanoi Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hanoi Medical 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>
      This study measures the effect of a 3-month patient education and self-management&#xD;
      intervention in a low-resource setting, on diabetes knowledge and levels of blood glucose&#xD;
      control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In Vietnam, there is a low level of diabetes knowledge among the general population, and&#xD;
      significantly lower awareness in rural areas compared with urban areas. This highlights the&#xD;
      urgent need for communication and education to improve the knowledge of the Vietnamese&#xD;
      population of patients with type 2 diabetes on risk factors, complications, prevention and&#xD;
      treatment. The main goal of this study is to evaluate the effects of a patient education and&#xD;
      self-management intervention as add-on to usual diabetes care in a low-resource setting on&#xD;
      diabetes knowledge and blood glucose control parameters in Vietnamese patients with type 2&#xD;
      diabetes.&#xD;
&#xD;
      This is a single-center, randomized, controlled study among adult out-patients with type 2&#xD;
      diabetes. Patients meeting the inclusion criteria are randomly assigned to a community&#xD;
      intervention or to usual diabetes care alone (control group) for a period of 3 months. The&#xD;
      intervention consists of group education on type 2 diabetes, including, in addition to usual&#xD;
      diabetes care: information on diet, exercise, drug therapy, and adherence. Each patient&#xD;
      should attend the group education monthly over 3 consecutive months. Usual diabetes care is&#xD;
      consistent with the ADA guidelines and comprises standard dietary and exercise advice in&#xD;
      addition to antidiabetes treatment. Diabetes knowledge is measured with a modified Michigan&#xD;
      University Diabetes Knowledge Test (MDKT). Other study outcomes includes change in mean&#xD;
      HbA1c, fasting blood glucose, and systolic blood pressure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">July 30, 2018</completion_date>
  <primary_completion_date type="Actual">July 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Disease awareness</measure>
    <time_frame>3-month</time_frame>
    <description>All patients complete a modified Michigan University Diabetes Knowledge Test (MDKT) (16) at baseline and at the end of the 3-month trial. The MDKT is a quick and low-cost method of assessing general knowledge of diabetes and diabetes self-care. The 23-item original questionnaire was translated into Vietnamese and adapted as required based on a pilot test performed in 10 people with type 2 diabetes, which resulted in one question being removed. The modified questionnaire therefore consist of 22 statements with multiple choice answers with 1 point awarded for each correct answer (Appendix 1). Patients who answer &gt;50% of the questions correctly considered to pass the knowledge test, and patients who answer &lt;50% of the questions correctly considered to fail. The proportion of successful patients (i.e. with MDKT total score ≥11) the study primary outcome.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">405</enrollment>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The intervention of group education on type 2 diabetes, including, in addition to usual diabetes care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients meeting the inclusion criteria assigned to usual diabetes care alone</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>patient education and self-management intervention in a low-resource setting on diabetes knowledge and levels of blood glucose control</intervention_name>
    <description>The intervention consisted group education on type 2 diabetes, including, in addition to usual diabetes care: information on diet, exercise, drug therapy, and adherence</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual diabetes care alone</intervention_name>
    <description>Usual diabetes care was consistent with the ADA guidelines (15) and comprised standard dietary and exercise advice in addition to antidiabetes treatment</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with type 2 diabetes as defined above&#xD;
&#xD;
          -  Aged 40-80 years old&#xD;
&#xD;
          -  Ability to attend monthly clinic visits and signed informed consent&#xD;
&#xD;
          -  All antidiabetes treatments were permitted including insulin&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A diagnosis of mental or neurological diseases that could interfere with the ability&#xD;
             to comply with study procedures&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Known drug or alcohol dependence&#xD;
&#xD;
          -  Requirement for a change in antidiabetes treatment over the study period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hanoi Medical University</name>
      <address>
        <city>Hanoi</city>
        <zip>10000</zip>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Vietnam</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 14, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>May 27, 2020</last_update_submitted>
  <last_update_submitted_qc>May 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hanoi Medical University</investigator_affiliation>
    <investigator_full_name>Ho Thi Kim Thanh</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Type 2 diabetes</keyword>
  <keyword>education</keyword>
  <keyword>glycemic</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>
  <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/NCT04403841
org study id: HMU16227
nct id: NCT04403841
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study measures the effect of a 3-month patient education and self-management
      intervention in a low-resource setting, on diabetes knowledge and levels of blood glucose
      control.
In Vietnam, there is a low level of diabetes knowledge among the general population, and
      significantly lower awareness in rural areas compared with urban areas. This highlights the
      urgent need for communication and education to improve the knowledge of the Vietnamese
      population of patients with type 2 diabetes on risk factors, complications, prevention and
      treatment. The main goal of this study is to evaluate the effects of a patient education and
      self-management intervention as add-on to usual diabetes care in a low-resource setting on
      diabetes knowledge and blood glucose control parameters in Vietnamese patients with type 2
      diabetes.

      This is a single-center, randomized, controlled study among adult out-patients with type 2
      diabetes. Patients meeting the inclusion criteria are randomly assigned to a community
      intervention or to usual diabetes care alone (control group) for a period of 3 months. The
      intervention consists of group education on type 2 diabetes, including, in addition to usual
      diabetes care: information on diet, exercise, drug therapy, and adherence. Each patient
      should attend the group education monthly over 3 consecutive months. Usual diabetes care is
      consistent with the ADA guidelines and comprises standard dietary and exercise advice in
      addition to antidiabetes treatment. Diabetes knowledge is measured with a modified Michigan
      University Diabetes Knowledge Test (MDKT). Other study outcomes includes change in mean
      HbA1c, fasting blood glucose, and systolic blood pressure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Disease awareness
time frame: 3-month
description: All patients complete a modified Michigan University Diabetes Knowledge Test (MDKT) (16) at baseline and at the end of the 3-month trial. The MDKT is a quick and low-cost method of assessing general knowledge of diabetes and diabetes self-care. The 23-item original questionnaire was translated into Vietnamese and adapted as required based on a pilot test performed in 10 people with type 2 diabetes, which resulted in one question being removed. The modified questionnaire therefore consist of 22 statements with multiple choice answers with 1 point awarded for each correct answer (Appendix 1). Patients who answer >50% of the questions correctly considered to pass the knowledge test, and patients who answer <50% of the questions correctly considered to fail. The proportion of successful patients (i.e. with MDKT total score ≥11) the study primary outcome.
arm group label: Intervention
arm group type: Other
description: The intervention of group education on type 2 diabetes, including, in addition to usual diabetes care
arm group label: Control
arm group type: Other
description: Patients meeting the inclusion criteria assigned to usual diabetes care alone
intervention type: Other
intervention name: patient education and self-management intervention in a low-resource setting on diabetes knowledge and levels of blood glucose control
description: The intervention consisted group education on type 2 diabetes, including, in addition to usual diabetes care: information on diet, exercise, drug therapy, and adherence
arm group label: Intervention
intervention type: Other
intervention name: Usual diabetes care alone
description: Usual diabetes care was consistent with the ADA guidelines (15) and comprised standard dietary and exercise advice in addition to antidiabetes treatment
arm group label: Control
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Vietnam
responsible party type: Principal Investigator
investigator affiliation: Hanoi Medical University
investigator full name: Ho Thi Kim Thanh
investigator title: Associate Professor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No