<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/NCT04474795</url>
  </required_header>
  <id_info>
    <org_study_id>202007060</org_study_id>
    <secondary_id>1K23HD096204-01A1</secondary_id>
    <nct_id>NCT04474795</nct_id>
  </id_info>
  <brief_title>Clinic to Community Connections - Broader Distribution</brief_title>
  <official_title>Clinic to Community Connections: Enhancing Prenatal to Postpartum Care Transitions to Prevent Type 2 Diabetes in Low Income Women With Gestational Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Longer Life Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Washington University School of Medicine</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 addresses education needs in gestational diabetes care and followup at the staff&#xD;
      and patient levels.&#xD;
&#xD;
      In the initial phase, nurses and community health workers will complete specific training&#xD;
      modules on gestational diabetes developed for this study. The effectiveness of the education&#xD;
      modules will be evaluated through pre/post surveys of participants assessing diabetes&#xD;
      knowledge, attitudes, and self-efficacy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 18, 2020</start_date>
  <completion_date type="Actual">August 22, 2022</completion_date>
  <primary_completion_date type="Actual">August 22, 2022</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>
    <intervention_model_description>Staff participants will complete surveys on diabetes knowledge, attitudes, and self-efficacy before and after completing online training modules on gestational diabetes.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Staff - Self-efficacy to Provide Diabetes Education Questionnaire (Newly Developed)</measure>
    <time_frame>Baseline and upon module completion (approximately 3 months)</time_frame>
    <description>Pre-Post change in staff participants' perceived self-efficacy to provide diabetes education (Mean score min:1 max 10) high score=more confident</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Staff - Diabetes Knowledge Test</measure>
    <time_frame>Baseline and upon module completion (approximately 3 months)</time_frame>
    <description>Change in diabetes knowledge measured by multiple choice test (% correct out of 21 items) high score =better knowledge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Staff - Diabetes Attitudes (Diabetes Attitudes Scale-3 (DAS-3))</measure>
    <time_frame>Baseline and upon module completion (approximately 3 months)</time_frame>
    <description>Change in diabetes attitudes measured by 3 subscales of DAS-3 (Mean score min 1, max 5) high score=better attitudes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Staff - Intention to Recommend Diabetes Prevention Activities Questionnaire (Newly Developed)</measure>
    <time_frame>Baseline and upon module completion (approximately 3 months)</time_frame>
    <description>Change in staff's intention to recommend postpartum diabetes screening measured by a survey developed for this study (mean score; min 1, max 5) higher score= increased intention to perform action</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Staff-General Self Efficacy Scale (Schwarzer)</measure>
    <time_frame>Baseline</time_frame>
    <description>General Self Efficacy measure (for use in validation of the Self-Efficacy for Providing Diabetes Education Scale) Sum Score (min: 10, max: 40); higher score=more confidence</description>
  </other_outcome>
  <other_outcome>
    <measure>Staff-Provider Teaching Motivation Questionnaire Intrinsic Motivation Subscale</measure>
    <time_frame>Baseline</time_frame>
    <description>Measure of teaching motivation (for use in validation of the Self-Efficacy for Providing Diabetes Education Scale) Mean score (min: 0, max 4) higher score=more intrinsic motivation</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">85</enrollment>
  <condition>Gestational Diabetes</condition>
  <condition>Gestational Diabetes Mellitus in Pregnancy</condition>
  <arm_group>
    <arm_group_label>Staff - Educational training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nurses, community health workers, and others involved in maternal healthcare</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Staff -Educational training</intervention_name>
    <description>Nurses and community health workers will complete 4 hours of online modules on gestational diabetes - Module 1: GDM Disease, Diagnosis and Complications; Module 2: Nutrition and Physical Activity Management; Module 3: Monitoring, Medications, and Avoiding Hypoglycemia; Module 4: Future Diabetes Risk and Prevention. Effectiveness of the training will be evaluated with pre/post evaluation of diabetes knowledge, attitudes, and self efficacy.</description>
    <arm_group_label>Staff - Educational training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Clinic staff: nurses (RN, LPN, BSN), community health workers, and others involved in&#xD;
        maternal child health care&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Clinic staff: individuals not involved in maternal child health care or who do not consent&#xD;
        to participate in study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cynthia J Herrick, MD, MPHS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Affinia Healthcare</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <results_first_submitted>January 30, 2023</results_first_submitted>
  <results_first_submitted_qc>January 30, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 27, 2023</results_first_posted>
  <last_update_submitted>January 30, 2023</last_update_submitted>
  <last_update_submitted_qc>January 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>diabetes in pregnancy</keyword>
  <keyword>type 2 diabetes prevention</keyword>
  <keyword>diabetes</keyword>
  <keyword>Care coordination</keyword>
  <keyword>care delivery</keyword>
  <keyword>care fragmentation</keyword>
  <keyword>community health worker</keyword>
  <keyword>community partnership</keyword>
  <keyword>community health aides</keyword>
  <keyword>federally qualified health center</keyword>
  <keyword>underserved population</keyword>
  <keyword>patient education</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes, Gestational</mesh_term>
    <mesh_term>Pregnancy in Diabetics</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 28, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/95/NCT04474795/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Staff - Educational Training</title>
          <description>Nurses, community health workers, and others involved in maternal healthcare&#xD;
Staff -Educational training: Nurses and community health workers will complete 4 hours of online modules on gestational diabetes - Module 1: GDM Disease, Diagnosis and Complications; Module 2: Nutrition and Physical Activity Management; Module 3: Monitoring, Medications, and Avoiding Hypoglycemia; Module 4: Future Diabetes Risk and Prevention. Effectiveness of the training will be evaluated with pre/post evaluation of diabetes knowledge, attitudes, and self efficacy.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="85"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed Pre-test</title>
              <participants_list>
                <participants group_id="P1" count="82"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Accessed Training Module 1</title>
              <participants_list>
                <participants group_id="P1" count="65"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Accessed Training Module 2</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Accessed Training Module 3</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Accessed Training Module 4</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="65"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Population of individuals who completed at least 50% of one of the measures on the baseline survey</population>
      <group_list>
        <group group_id="B1">
          <title>Staff - Educational Training</title>
          <description>Nurses, community health workers, and others involved in maternal healthcare&#xD;
Staff -Educational training: Nurses and community health workers will complete 4 hours of online modules on gestational diabetes - Module 1: GDM Disease, Diagnosis and Complications; Module 2: Nutrition and Physical Activity Management; Module 3: Monitoring, Medications, and Avoiding Hypoglycemia; Module 4: Future Diabetes Risk and Prevention. Effectiveness of the training will be evaluated with pre/post evaluation of diabetes knowledge, attitudes, and self efficacy.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="82"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37.0" lower_limit="30.0" upper_limit="49.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="81"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Black or African American, non-Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Latinx or Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native American, Asian, another race</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White, non-Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education/Training</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Nurses (RN/LPN/CHN), CDCES, or RD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CHW or MA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Specialty</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Internal Medicine/Family Medicine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ob-Gyn/Maternal -Child Health</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>GDM knowledge score</title>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <title>Overall Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56.5" lower_limit="48.4" upper_limit="65.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Module 1 Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60.0" lower_limit="60.0" upper_limit="80.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Module 2 Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66.7" lower_limit="50.0" upper_limit="66.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Module 3 Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57.1" lower_limit="42.9" upper_limit="57.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Module 4 Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40.0" lower_limit="40.0" upper_limit="60.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Self-Efficacy to Provide Diabetes Education Scale</title>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.00" lower_limit="5.90" upper_limit="8.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diabetes Attitudes Scale</title>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <title>Patient autonomy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.25" lower_limit="3.97" upper_limit="4.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Value of tight control</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.14" lower_limit="3.71" upper_limit="4.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Need for special training</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.80" lower_limit="4.60" upper_limit="5.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Intention to Recommend Diabetes Prevention Measures</title>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.63" lower_limit="4.13" upper_limit="5.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Staff - Self-efficacy to Provide Diabetes Education Questionnaire (Newly Developed)</title>
        <description>Pre-Post change in staff participants' perceived self-efficacy to provide diabetes education (Mean score min:1 max 10) high score=more confident</description>
        <time_frame>Baseline and upon module completion (approximately 3 months)</time_frame>
        <population>Population who completed pre and post training assessments and accessed all 4 training modules</population>
        <group_list>
          <group group_id="O1">
            <title>Staff - Educational Training</title>
            <description>Nurses, community health workers, and others involved in maternal healthcare&#xD;
Staff -Educational training: Nurses and community health workers will complete 4 hours of online modules on gestational diabetes - Module 1: GDM Disease, Diagnosis and Complications; Module 2: Nutrition and Physical Activity Management; Module 3: Monitoring, Medications, and Avoiding Hypoglycemia; Module 4: Future Diabetes Risk and Prevention. Effectiveness of the training will be evaluated with pre/post evaluation of diabetes knowledge, attitudes, and self efficacy.</description>
          </group>
        </group_list>
        <measure>
          <title>Staff - Self-efficacy to Provide Diabetes Education Questionnaire (Newly Developed)</title>
          <description>Pre-Post change in staff participants' perceived self-efficacy to provide diabetes education (Mean score min:1 max 10) high score=more confident</description>
          <population>Population who completed pre and post training assessments and accessed all 4 training modules</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-training Score (Baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.60" lower_limit="4.93" upper_limit="7.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-training Score (Module Completion)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.33" lower_limit="9.00" upper_limit="9.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Compared pre and post training scores</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Wilcoxon paired signed rank test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Staff - Diabetes Knowledge Test</title>
        <description>Change in diabetes knowledge measured by multiple choice test (% correct out of 21 items) high score =better knowledge</description>
        <time_frame>Baseline and upon module completion (approximately 3 months)</time_frame>
        <population>Individuals who completed pre and post-test assessments and accessed all 4 training modules</population>
        <group_list>
          <group group_id="O1">
            <title>Staff - Educational Training</title>
            <description>Nurses, community health workers, and others involved in maternal healthcare&#xD;
Staff -Educational training: Nurses and community health workers will complete 4 hours of online modules on gestational diabetes - Module 1: GDM Disease, Diagnosis and Complications; Module 2: Nutrition and Physical Activity Management; Module 3: Monitoring, Medications, and Avoiding Hypoglycemia; Module 4: Future Diabetes Risk and Prevention. Effectiveness of the training will be evaluated with pre/post evaluation of diabetes knowledge, attitudes, and self efficacy.</description>
          </group>
        </group_list>
        <measure>
          <title>Staff - Diabetes Knowledge Test</title>
          <description>Change in diabetes knowledge measured by multiple choice test (% correct out of 21 items) high score =better knowledge</description>
          <population>Individuals who completed pre and post-test assessments and accessed all 4 training modules</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-training score (Baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.5" lower_limit="48.9" upper_limit="65.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-training score (Module completion)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.3" lower_limit="65.2" upper_limit="87.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Comparison of scores pre and post training in individuals who completed training modules</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Wilcoxon paired signed rank test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Staff - Diabetes Attitudes (Diabetes Attitudes Scale-3 (DAS-3))</title>
        <description>Change in diabetes attitudes measured by 3 subscales of DAS-3 (Mean score min 1, max 5) high score=better attitudes</description>
        <time_frame>Baseline and upon module completion (approximately 3 months)</time_frame>
        <population>Pre and post training scores in individuals who completed training modules</population>
        <group_list>
          <group group_id="O1">
            <title>Staff - Educational Training</title>
            <description>Nurses, community health workers, and others involved in maternal healthcare&#xD;
Staff -Educational training: Nurses and community health workers will complete 4 hours of online modules on gestational diabetes - Module 1: GDM Disease, Diagnosis and Complications; Module 2: Nutrition and Physical Activity Management; Module 3: Monitoring, Medications, and Avoiding Hypoglycemia; Module 4: Future Diabetes Risk and Prevention. Effectiveness of the training will be evaluated with pre/post evaluation of diabetes knowledge, attitudes, and self efficacy.</description>
          </group>
        </group_list>
        <measure>
          <title>Staff - Diabetes Attitudes (Diabetes Attitudes Scale-3 (DAS-3))</title>
          <description>Change in diabetes attitudes measured by 3 subscales of DAS-3 (Mean score min 1, max 5) high score=better attitudes</description>
          <population>Pre and post training scores in individuals who completed training modules</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-training score (Patient Autonomy)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.44" lower_limit="3.75" upper_limit="4.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-training score (Patient Autonomy)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.38" lower_limit="3.91" upper_limit="4.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre-training score (value of tight control)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.07" lower_limit="3.75" upper_limit="4.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-training score (value of tight control)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.43" lower_limit="4.00" upper_limit="4.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre-training score (need for special training)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.00" lower_limit="4.60" upper_limit="5.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-training score (need for special training)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.00" lower_limit="4.65" upper_limit="5.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Patient autonomy</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.606</p_value>
            <method>Wilcoxon paired signed rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Value of tight control</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.003</p_value>
            <method>Wilcoxon paired signed rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Need for Special Training</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.475</p_value>
            <method>Wilcoxon paired signed rank test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Staff - Intention to Recommend Diabetes Prevention Activities Questionnaire (Newly Developed)</title>
        <description>Change in staff's intention to recommend postpartum diabetes screening measured by a survey developed for this study (mean score; min 1, max 5) higher score= increased intention to perform action</description>
        <time_frame>Baseline and upon module completion (approximately 3 months)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Staff - Educational Training</title>
            <description>Nurses, community health workers, and others involved in maternal healthcare&#xD;
Staff -Educational training: Nurses and community health workers will complete 4 hours of online modules on gestational diabetes - Module 1: GDM Disease, Diagnosis and Complications; Module 2: Nutrition and Physical Activity Management; Module 3: Monitoring, Medications, and Avoiding Hypoglycemia; Module 4: Future Diabetes Risk and Prevention. Effectiveness of the training will be evaluated with pre/post evaluation of diabetes knowledge, attitudes, and self efficacy.</description>
          </group>
        </group_list>
        <measure>
          <title>Staff - Intention to Recommend Diabetes Prevention Activities Questionnaire (Newly Developed)</title>
          <description>Change in staff's intention to recommend postpartum diabetes screening measured by a survey developed for this study (mean score; min 1, max 5) higher score= increased intention to perform action</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-training score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.81" lower_limit="4.37" upper_limit="5.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-training score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.00" lower_limit="5.00" upper_limit="5.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.009</p_value>
            <method>Wilcoxon paired signed rank test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Staff-General Self Efficacy Scale (Schwarzer)</title>
        <description>General Self Efficacy measure (for use in validation of the Self-Efficacy for Providing Diabetes Education Scale) Sum Score (min: 10, max: 40); higher score=more confidence</description>
        <time_frame>Baseline</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Staff-Provider Teaching Motivation Questionnaire Intrinsic Motivation Subscale</title>
        <description>Measure of teaching motivation (for use in validation of the Self-Efficacy for Providing Diabetes Education Scale) Mean score (min: 0, max 4) higher score=more intrinsic motivation</description>
        <time_frame>Baseline</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Individuals were not assigned to an intervention that was anticipated to result in adverse events. Individuals had the opportunity to contact the study team with questions or concerns at any time over the course of the study.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Staff - Educational Training</title>
          <description>Nurses, community health workers, and others involved in maternal healthcare&#xD;
Staff -Educational training: Nurses and community health workers will complete 4 hours of online modules on gestational diabetes - Module 1: GDM Disease, Diagnosis and Complications; Module 2: Nutrition and Physical Activity Management; Module 3: Monitoring, Medications, and Avoiding Hypoglycemia; Module 4: Future Diabetes Risk and Prevention. Effectiveness of the training will be evaluated with pre/post evaluation of diabetes knowledge, attitudes, and self efficacy.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="82"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="82"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="82"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Cynthia Herrick, MD, MPHS</name_or_title>
      <organization>Washington University In St. Louis School of Medicine</organization>
      <phone>3147470278</phone>
      <email>herrickc@wustl.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04474795
org study id: 202007060
secondary id: 1K23HD096204-01A1
nct id: NCT04474795
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study addresses education needs in gestational diabetes care and followup at the staff
      and patient levels.

      In the initial phase, nurses and community health workers will complete specific training
      modules on gestational diabetes developed for this study. The effectiveness of the education
      modules will be evaluated through pre/post surveys of participants assessing diabetes
      knowledge, attitudes, and self-efficacy.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Staff participants will complete surveys on diabetes knowledge, attitudes, and self-efficacy before and after completing online training modules on gestational diabetes.
primary purpose: Prevention
masking: None (Open Label)
measure: Staff - Self-efficacy to Provide Diabetes Education Questionnaire (Newly Developed)
time frame: Baseline and upon module completion (approximately 3 months)
description: Pre-Post change in staff participants' perceived self-efficacy to provide diabetes education (Mean score min:1 max 10) high score=more confident
measure: Staff - Diabetes Knowledge Test
time frame: Baseline and upon module completion (approximately 3 months)
description: Change in diabetes knowledge measured by multiple choice test (% correct out of 21 items) high score =better knowledge
measure: Staff - Diabetes Attitudes (Diabetes Attitudes Scale-3 (DAS-3))
time frame: Baseline and upon module completion (approximately 3 months)
description: Change in diabetes attitudes measured by 3 subscales of DAS-3 (Mean score min 1, max 5) high score=better attitudes
measure: Staff - Intention to Recommend Diabetes Prevention Activities Questionnaire (Newly Developed)
time frame: Baseline and upon module completion (approximately 3 months)
description: Change in staff's intention to recommend postpartum diabetes screening measured by a survey developed for this study (mean score; min 1, max 5) higher score= increased intention to perform action
measure: Staff-General Self Efficacy Scale (Schwarzer)
time frame: Baseline
description: General Self Efficacy measure (for use in validation of the Self-Efficacy for Providing Diabetes Education Scale) Sum Score (min: 10, max: 40); higher score=more confidence
measure: Staff-Provider Teaching Motivation Questionnaire Intrinsic Motivation Subscale
time frame: Baseline
description: Measure of teaching motivation (for use in validation of the Self-Efficacy for Providing Diabetes Education Scale) Mean score (min: 0, max 4) higher score=more intrinsic motivation
arm group label: Staff - Educational training
arm group type: Experimental
description: Nurses, community health workers, and others involved in maternal healthcare
intervention type: Behavioral
intervention name: Staff -Educational training
description: Nurses and community health workers will complete 4 hours of online modules on gestational diabetes - Module 1: GDM Disease, Diagnosis and Complications; Module 2: Nutrition and Physical Activity Management; Module 3: Monitoring, Medications, and Avoiding Hypoglycemia; Module 4: Future Diabetes Risk and Prevention. Effectiveness of the training will be evaluated with pre/post evaluation of diabetes knowledge, attitudes, and self efficacy.
arm group label: Staff - Educational training
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Cynthia J Herrick, MD, MPHS
role: Principal Investigator
affiliation: Washington University School of Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes, Gestational
mesh term: Pregnancy in Diabetics
mesh term: Diabetes Mellitus
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 