<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/NCT02977130</url>
  </required_header>
  <id_info>
    <org_study_id>201404062RINB</org_study_id>
    <nct_id>NCT02977130</nct_id>
  </id_info>
  <brief_title>The Influence of Conversation Map on the Health Behaviors of Diabetes Patients</brief_title>
  <official_title>The Influence of Conversation Map on the Health Behaviors of Diabetes Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Science and Technology, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The American Diabetes Association indicates that diabetes self-management is a skill that&#xD;
      diabetic patients must learn in the Diabetes Self-Management Education; thus, this&#xD;
      contributes to shared care for diabetes, in which teams of physicians, professional nurses,&#xD;
      and dietitians offer shared care to patients. However, according to the statistical analysis&#xD;
      of the conditions of glycemic control in diabetic patients in 28 countries across 4&#xD;
      continents (Asia, Africa, Europe, and South America), the mean glycated hemoglobin (HbA1c) of&#xD;
      the 12,727 patients was 9.5% by Litwak et al. in 2013. In Taiwan, a national survey among&#xD;
      diabetic patients in a shared-care program found that the percentage of patients with HbA1c&#xD;
      lower than 7% increased by 6.5% from 2006 to 2011; yet, among the 720 patients who completed&#xD;
      both surveys in 2006 and 2011, the percentage with HbA1c lower than 7% decreased by 2.1%&#xD;
      during that period. These results suggest that despite the increase in the proportion of&#xD;
      patients who successfully managed their diabetes, some patients still encountered difficulty&#xD;
      in glycemic control.Therefore, numerous health education tools on diabetes continue to be&#xD;
      developed. In 2011,JoAnn et al. determined that the mode of health care had a substantial&#xD;
      influence on the dietary habits of diabetic patients, and that individual health education&#xD;
      had the largest effect on diabetes control. In addition, using the conversation map for&#xD;
      diabetes control also had a substantial influence on improving health behaviors. Among&#xD;
      existing studies that have adopted the conversation map, no large-scale research has been&#xD;
      conducted, the research samples and relevant studies in Taiwan have been scant, and no&#xD;
      theoretical foundation has been applied in evaluating the effects of the conversation map.&#xD;
      Accordingly, the investigators aimed to enhance the mutual experience exchange and learning&#xD;
      among diabetic patients through adopting the conversation map to observe its influence on&#xD;
      their health behaviors by incorporating it into existing health education modalities.&#xD;
      Furthermore, on the basis of the Health Belief Model, a relevant questionnaire was designed&#xD;
      for assessing the effectiveness of glycemic control in diabetic patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</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>Diet- and exercise-related health behaviors</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Glycated hemoglobin (HbA1c)</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">615</enrollment>
  <condition>Diabetes Mellitus</condition>
  <condition>Health Knowledge, Attitudes, Practice</condition>
  <condition>Health Behavior</condition>
  <condition>Glycated Hemoglobin (HbA1c)</condition>
  <arm_group>
    <arm_group_label>Map group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients receiving general shared care for diabetes and the conversation map intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients receiving general shared care for diabetes</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Map group</intervention_name>
    <description>diabetes shared care plus conversation map intervention</description>
    <arm_group_label>Map group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control group</intervention_name>
    <description>diabetes shared care</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with type 2 diabetes mellitus between 30 and 80 years of age who participated&#xD;
             in a diabetes shared-care program.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients were excluded if they had renal insufficiency (eGFR &lt;30 mL•min / 1.732), were&#xD;
             not ambulatory, or were unable to answer the questionnaire independently.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jiun-Hau Huang, SM, ScD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University</affiliation>
  </overall_official>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 24, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>November 29, 2016</last_update_submitted>
  <last_update_submitted_qc>November 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 30, 2016</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>Diabetes Mellitus</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/NCT02977130
org study id: 201404062RINB
nct id: NCT02977130
lead sponsor: 
collaborator: 
has dmc: No
The American Diabetes Association indicates that diabetes self-management is a skill that
      diabetic patients must learn in the Diabetes Self-Management Education; thus, this
      contributes to shared care for diabetes, in which teams of physicians, professional nurses,
      and dietitians offer shared care to patients. However, according to the statistical analysis
      of the conditions of glycemic control in diabetic patients in 28 countries across 4
      continents (Asia, Africa, Europe, and South America), the mean glycated hemoglobin (HbA1c) of
      the 12,727 patients was 9.5% by Litwak et al. in 2013. In Taiwan, a national survey among
      diabetic patients in a shared-care program found that the percentage of patients with HbA1c
      lower than 7% increased by 6.5% from 2006 to 2011; yet, among the 720 patients who completed
      both surveys in 2006 and 2011, the percentage with HbA1c lower than 7% decreased by 2.1%
      during that period. These results suggest that despite the increase in the proportion of
      patients who successfully managed their diabetes, some patients still encountered difficulty
      in glycemic control.Therefore, numerous health education tools on diabetes continue to be
      developed. In 2011,JoAnn et al. determined that the mode of health care had a substantial
      influence on the dietary habits of diabetic patients, and that individual health education
      had the largest effect on diabetes control. In addition, using the conversation map for
      diabetes control also had a substantial influence on improving health behaviors. Among
      existing studies that have adopted the conversation map, no large-scale research has been
      conducted, the research samples and relevant studies in Taiwan have been scant, and no
      theoretical foundation has been applied in evaluating the effects of the conversation map.
      Accordingly, the investigators aimed to enhance the mutual experience exchange and learning
      among diabetic patients through adopting the conversation map to observe its influence on
      their health behaviors by incorporating it into existing health education modalities.
      Furthermore, on the basis of the Health Belief Model, a relevant questionnaire was designed
      for assessing the effectiveness of glycemic control in diabetic patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Diet- and exercise-related health behaviors
time frame: 3 months
measure: Glycated hemoglobin (HbA1c)
time frame: 3 months
arm group label: Map group
arm group type: Experimental
description: patients receiving general shared care for diabetes and the conversation map intervention
arm group label: Control group
arm group type: Active Comparator
description: patients receiving general shared care for diabetes
intervention type: Behavioral
intervention name: Map group
description: diabetes shared care plus conversation map intervention
arm group label: Map group
intervention type: Behavioral
intervention name: Control group
description: diabetes shared care
arm group label: Control group
criteria: 
gender: All
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jiun-Hau Huang, SM, ScD
role: Principal Investigator
affiliation: National Taiwan University
responsible party type: Sponsor
mesh term: Diabetes Mellitus
sharing ipd: No