<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/NCT03786718</url>
  </required_header>
  <id_info>
    <org_study_id>181727</org_study_id>
    <secondary_id>5K23DK106511</secondary_id>
    <nct_id>NCT03786718</nct_id>
  </id_info>
  <brief_title>Usability of Diabetes Dashboard Embedded Within a Patient Web Portal</brief_title>
  <official_title>Usability of Diabetes Dashboard Embedded Within a Patient Web Portal: A Prospective Longitudinal Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Vanderbilt University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</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 purpose of this study is to conduct a prospective, longitudinal study to evaluate the&#xD;
      usability of a patient-facing diabetes dashboard delivered via an established patient web&#xD;
      portal.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Up to 70 adult patients with type 2 diabetes mellitus will be enrolled and given access to a&#xD;
      diabetes dashboard within an existing patient web portal. Patients will be invited by mail&#xD;
      (or email) to be screened for enrollment in the study. Patients may also respond at a study&#xD;
      flyer and contact the study team to be screened for enrollment. Eligible and interested&#xD;
      patients will be emailed a link to a secure study website where they will complete a web&#xD;
      consent form. After enrollment, participants will complete a baseline web-based&#xD;
      questionnaire. After completing the enrollment questionnaire, they will be provided access to&#xD;
      the diabetes dashboard within the patient web portal for one month. After one month,&#xD;
      participants will receive an additional follow-up (final) questionnaire to assess outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 27, 2018</start_date>
  <completion_date type="Actual">May 13, 2019</completion_date>
  <primary_completion_date type="Actual">May 13, 2019</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>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Usability</measure>
    <time_frame>one month follow-up (T1)</time_frame>
    <description>The System Usability Scale (SUS) will be administered to all study participants at one month follow-up (T1). The SUS is a validated measure of usability. The ten items are scored on a five-point Likert scale. The item scores are summed and then converted to a score ranging from 0 (worst) to 100 (best). A score of above 68 indicative of &quot;above average&quot; usability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>User Experience - Quantitative</measure>
    <time_frame>one month follow-up (T1)</time_frame>
    <description>User experience will be assessed by study-specific survey items administered to all study participants at the end of the study period (T1). The survey items will inquire about participants' perspectives on particular features of the Patient-facing Diabetes Dashboard. Participants were asked to indicate which features, if any: (1) they found useful for managing their diabetes and which features, (2) improved their understanding of their diabetes health data, and (3) should be removed. In addition, participants indicated whether they intended to use the dashboard going forward if it remained available.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>User Experience - Qualitative</measure>
    <time_frame>one month follow-up (T1)</time_frame>
    <description>At the end of the study period (T1), a subset of study participants will be invited to complete a semi-structured interview to provide a deeper understanding of their experience using the dashboard.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>System Usage Data</measure>
    <time_frame>one month follow-up (T1)</time_frame>
    <description>This is a composite outcome measure of participants' self-reported total number of diabetes dashboard visits, total duration of dashboard use, use of embedded educational links, utilization of embedded functionality to secure message healthcare team member(s), and use of an embedded link to American Diabetes Association Online Community and will be queried at the end of the study period (T1).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Diabetes Knowledge</measure>
    <time_frame>enrollment (T0) and one month follow-up (T1)</time_frame>
    <description>The Short Diabetes Knowledge Instrument (SDKI) was used to measure diabetes knowledge including diabetes diet, symptoms of hypoglycemia, foot care and importance of physical activity. The SDKI is a 13-item scale with scores ranging from 0 to 13 representing number of items answered correctly. The Short Diabetes Knowledge Instrument (SDKI) will be administered to all study patients at enrollment (T0) and one month follow-up (T1).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Diabetes Self-Care</measure>
    <time_frame>enrollment (T0) and one month follow-up (T1)</time_frame>
    <description>Diabetes self-care will be measured using the Summary of Diabetes Self-Care Activities (SDSCA), an 11-item questionnaire of diabetes self-management that assess the following six aspects of the diabetes regimen: general diet (2 items), specific diet (2 items), exercise (2 items), blood-glucose testing (2 items), foot care (2 items), and smoking (1 items). Item responses use the metric &quot;days per week&quot; except for a single item about smoking status which is yes or no. Each of the five aspects (excluding smoking) is assigned a mean score based on number of days per week. The Summary of Diabetes Self-Care Activities (SDSCA) will be administered to all study patients at enrollment (T0) and one month follow-up (T1).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Diabetes Self-Efficacy</measure>
    <time_frame>enrollment (T0) and one month follow-up (T1)</time_frame>
    <description>The Perceived Diabetes Self-Management Scale (PDSMS) is a valid measure of diabetes self-efficacy. The PDSMS will be administered to all study participants at enrollment (T0) and one month follow-up (T1). Eight items are scored on a five-point Likert scale. The total PDSMS score can range from 8 to 40, with higher scores indicating more confidence in self-managing one's diabetes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Diabetes Distress</measure>
    <time_frame>enrollment (T0) and one month follow-up (T1)</time_frame>
    <description>The Problem Areas in Diabetes Scale (PAID-5) is a valid measure of diabetes distress. The PAID-5 will be administered to all study participants at enrollment (T0) and one month follow-up (T1). Total scores on the PAID-5 can range from 0 to 20, with higher scores suggesting greater diabetes-related emotional distress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Knowledge of Diabetes Measures</measure>
    <time_frame>enrollment (T0) and one month follow-up (T1)</time_frame>
    <description>Unique study specific items to assess participants' knowledge of measures of diabetes health status (e.g., Hemoglobin A1C) will be administered to all study participants at enrollment (T0) and one month follow-up (T1).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Diabetes Understanding</measure>
    <time_frame>enrollment (T0) and one month follow-up (T1)</time_frame>
    <description>The Diabetes Care Profile (DCP) is a self-administered questionnaire that assesses the social and psychological factors related to diabetes and its treatment. The instrument includes sixteen scales. The Understanding Scale of the DCP contains 13 items that assesses respondents' perceived understanding of elements of diabetes self-care (e.g., diet for blood sugar control). We administered 9 of the 13 items to study participants, excluding items that referenced elements of self-management that are not covered in My Diabetes Care (e.g., pregnancy and diabetes). Respondents rate their understanding on a five-point Likert scale. The scale scores range from 1 to 5 and represents the average item score for the scale (∑ Q1-9/ Count of non-missing items). High scores indicate higher perceived understanding.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Attitudes</measure>
    <time_frame>enrollment (T0) and one month follow-up (T1)</time_frame>
    <description>Unique study specific survey items to assess participants' attitudes toward receiving social and goal-based comparison information regarding their diabetes health status will be administered to all study participants at enrollment (T0) and one month follow-up (T1).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Patient Activation</measure>
    <time_frame>enrollment (T0) and one month follow-up (T1)</time_frame>
    <description>The Patient Activation Measure® (PAM-13) scale will be administered to all study participants at enrollment (T0) and one month follow-up (T1). The 13-item PAM® survey is a validated measure of patient activation (i.e., the knowledge, skills and confidence a person has in managing their own health and health care) and consists of 13 items. Each item uses a 4-point Likert-type scale of response options ranging from strongly disagree to strongly agree to elicit endorsement of a particular statement. PAM® survey item responses result in total raw scores ranging from 13 to 52, which we converted to the linear interval scale of patient activation scores, ranging from 0 (lowest activation) to 100 (highest activation).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">69</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patient-facing Diabetes Dashboard</intervention_name>
    <description>The Patient-facing Diabetes Dashboard is embedded within a patient web portal and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons and gamification), provides literacy level appropriate educational resources, and contains secure-messaging capability.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 2 Diabetes Mellitus&#xD;
&#xD;
          -  Currently being treated with at least one antihyperglycemic medication&#xD;
&#xD;
          -  Able to speak and read in English&#xD;
&#xD;
          -  Have reliable access to a computer with internet access&#xD;
&#xD;
          -  Existing My Health at Vanderbilt (i.e., patient portal) account&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Living in long term care facilities&#xD;
&#xD;
          -  Known cognitive deficits&#xD;
&#xD;
          -  Severe visual or hearing impairment&#xD;
&#xD;
          -  Unintelligible speech (e.g., dysarthria)&#xD;
&#xD;
          -  Currently participating in another diabetes-related research study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>William Martinez, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>William Martinez</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <results_first_submitted>May 8, 2020</results_first_submitted>
  <results_first_submitted_qc>June 22, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">July 7, 2020</results_first_posted>
  <last_update_submitted>May 5, 2023</last_update_submitted>
  <last_update_submitted_qc>May 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
    <investigator_full_name>William Martinez, MD, MS</investigator_full_name>
    <investigator_title>Assistant Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Diabetes</keyword>
  <keyword>Patient Web Portals</keyword>
  <keyword>Usability</keyword>
  <keyword>Health Information Technology</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>
  <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>May 3, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT03786718/Prot_SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 13, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT03786718/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Of the 69 enrolled participants, 67 completed the baseline questionnaire and were with given access to the intervention. Two participants never completed the baseline questionnaire despite reminders and therefore did not receive access to the intervention and were withdrawn.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Intervention</title>
          <description>Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated.&#xD;
Patient-facing Diabetes Dashboard: The Patient-facing Diabetes Dashboard (also known as My Diabetes Care) is embedded within a patient web portal and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons), provides literacy level appropriate educational resources, and contains secure-messaging capability.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="67"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Did not use the intervention</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>diagnosis changed from type 2 to type 1</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>67 participants were provided access to the intervention, however, analysis was limited to 60 participants who completed the study (i.e., used the intervention and submitted both pre- and post-study questionnaires).</population>
      <group_list>
        <group group_id="B1">
          <title>Intervention</title>
          <description>Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated.&#xD;
Patient-facing Diabetes Dashboard: The Patient-facing Diabetes Dashboard (also known as My Diabetes Care) is embedded within a patient web portal and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons), provides literacy level appropriate educational resources, and contains secure-messaging capability.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="60"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57.5" spread="13.0"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>High school/GED</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Some college/technical school</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>College degree</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Graduate or professional degree</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Health Literacy</title>
          <description>Health literacy was assessed using a validated one-item screener that asked respondents to rate their confidence independently filling out medical forms on a scale ranging from 'extremely' to 'not at all' confident. Consistent with prior studies, we categorized participants noting any lack of confidence filling out medical forms as having limited health literacy.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Adequate</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Limited</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>eHealth Literacy</title>
          <description>eHealth refers to healthcare services provided electronically via the Internet. eHealth Literacy refers to the knowledge, comfort, and perceived skill at finding, evaluating, and applying electronic health information to health problems. eHealth Literacy was assessed by the eHEALS scale which contains 8 items, measured with a 5-point Likert scale with response options ranging from &quot;strongly disagree=1&quot; to &quot;strongly agree=5.&quot; Total scores of the eHEALS are summed to range from 8 to 40, with higher scores representing higher self-perceived eHealth literacy.</description>
          <population>One participant did not complete the eHEALS scale</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.5" spread="5.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Patient Portal Usage</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Weekly</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Monthly</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Computer and Smartphone Usage</title>
          <description>Participants could select more than one so totals may exceed 100%.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Desktop</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tablet</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Smartphone</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hemoglobin A1c</title>
          <population>Two participants were missing hemoglobin A1C data.</population>
          <units>%</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.5" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Insulin Use</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Time with diagnosis of diabetes</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13.1" spread="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Comorbidities</title>
          <description>Number of participants with comorbid hyperlipidemia and/or hypertension</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Hyperlipidemia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypertension</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Usability</title>
        <description>The System Usability Scale (SUS) will be administered to all study participants at one month follow-up (T1). The SUS is a validated measure of usability. The ten items are scored on a five-point Likert scale. The item scores are summed and then converted to a score ranging from 0 (worst) to 100 (best). A score of above 68 indicative of &quot;above average&quot; usability.</description>
        <time_frame>one month follow-up (T1)</time_frame>
        <population>All 60 participants that completed the study (i.e., used the intervention and complete pre- and post-questionnaires.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated.&#xD;
Patient-facing Diabetes Dashboard: The Patient-facing Diabetes Dashboard (also known as My Diabetes Care) is embedded within a patient web portal and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons), provides literacy level appropriate educational resources, and contains secure-messaging capability.</description>
          </group>
        </group_list>
        <measure>
          <title>Usability</title>
          <description>The System Usability Scale (SUS) will be administered to all study participants at one month follow-up (T1). The SUS is a validated measure of usability. The ten items are scored on a five-point Likert scale. The item scores are summed and then converted to a score ranging from 0 (worst) to 100 (best). A score of above 68 indicative of &quot;above average&quot; usability.</description>
          <population>All 60 participants that completed the study (i.e., used the intervention and complete pre- and post-questionnaires.</population>
          <units>score 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="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.8" lower_limit="72.5" upper_limit="87.5"/>
                  </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>Due to nonnormality, we used nonparametric tests to analyze the data. This analysis is a one sample median test of participants' median SUS score compared to the threshold score of 68 indicative of 'above average' usability.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>One sample median test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>User Experience - Quantitative</title>
        <description>User experience will be assessed by study-specific survey items administered to all study participants at the end of the study period (T1). The survey items will inquire about participants' perspectives on particular features of the Patient-facing Diabetes Dashboard. Participants were asked to indicate which features, if any: (1) they found useful for managing their diabetes and which features, (2) improved their understanding of their diabetes health data, and (3) should be removed. In addition, participants indicated whether they intended to use the dashboard going forward if it remained available.</description>
        <time_frame>one month follow-up (T1)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated.&#xD;
Patient-facing Diabetes Dashboard: The Patient-facing Diabetes Dashboard (also known as My Diabetes Care) is embedded within a patient web portal and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons), provides literacy level appropriate educational resources, and contains secure-messaging capability.</description>
          </group>
        </group_list>
        <measure>
          <title>User Experience - Quantitative</title>
          <description>User experience will be assessed by study-specific survey items administered to all study participants at the end of the study period (T1). The survey items will inquire about participants' perspectives on particular features of the Patient-facing Diabetes Dashboard. Participants were asked to indicate which features, if any: (1) they found useful for managing their diabetes and which features, (2) improved their understanding of their diabetes health data, and (3) should be removed. In addition, participants indicated whether they intended to use the dashboard going forward if it remained available.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Star Status Indicator - useful</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hover Over Info Icons - useful</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Goal, Caution, and Warning Ranges - useful</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patients Like Me Data - useful</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Literacy Sensitive Education Links - useful</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diabetes Online Community - useful</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Star Status Indicator - understanding</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hover Over Info Icons - understanding</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Goal, Caution, and Warning Ranges - understanding</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Literacy Sensitive Education Links - understanding</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diabetes Online Community - understanding</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Star Status Indicator - removed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hover Over Info Icons - removed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Goal, Caution, and Warning Ranges - removed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patients Like Me Data - removed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Literacy Sensitive Education Links - removed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diabetes Online Community - removed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intend to use going forward</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>User Experience - Qualitative</title>
        <description>At the end of the study period (T1), a subset of study participants will be invited to complete a semi-structured interview to provide a deeper understanding of their experience using the dashboard.</description>
        <time_frame>one month follow-up (T1)</time_frame>
        <population>participants that participated in a semi-structured interview</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated.&#xD;
Patient-facing Diabetes Dashboard: The Patient-facing Diabetes Dashboard is embedded within a patient web portal and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons and gamification), provides literacy level appropriate educational resources, and contains secure-messaging capability.</description>
          </group>
        </group_list>
        <measure>
          <title>User Experience - Qualitative</title>
          <description>At the end of the study period (T1), a subset of study participants will be invited to complete a semi-structured interview to provide a deeper understanding of their experience using the dashboard.</description>
          <population>participants that participated in a semi-structured interview</population>
          <units>areas for improvement identified</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>System Usage Data</title>
        <description>This is a composite outcome measure of participants' self-reported total number of diabetes dashboard visits, total duration of dashboard use, use of embedded educational links, utilization of embedded functionality to secure message healthcare team member(s), and use of an embedded link to American Diabetes Association Online Community and will be queried at the end of the study period (T1).</description>
        <time_frame>one month follow-up (T1)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated.&#xD;
Patient-facing Diabetes Dashboard: The Patient-facing Diabetes Dashboard (also known as My Diabetes Care) is embedded within a patient web portal and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons), provides literacy level appropriate educational resources, and contains secure-messaging capability.</description>
          </group>
        </group_list>
        <measure>
          <title>System Usage Data</title>
          <description>This is a composite outcome measure of participants' self-reported total number of diabetes dashboard visits, total duration of dashboard use, use of embedded educational links, utilization of embedded functionality to secure message healthcare team member(s), and use of an embedded link to American Diabetes Association Online Community and will be queried at the end of the study period (T1).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total number of visits: 1-2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total number of visits: 3-4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total number of visits: 5-6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total number of visits: 7+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total minutes spent: &lt;5 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total minutes spent: 5-9 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total minutes spent: 10-14 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total minutes spent: 15+ minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Used literacy sensitive education links</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Used secure messaging</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Used diabetes online community</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Used info icon with explanation of health measure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Diabetes Knowledge</title>
        <description>The Short Diabetes Knowledge Instrument (SDKI) was used to measure diabetes knowledge including diabetes diet, symptoms of hypoglycemia, foot care and importance of physical activity. The SDKI is a 13-item scale with scores ranging from 0 to 13 representing number of items answered correctly. The Short Diabetes Knowledge Instrument (SDKI) will be administered to all study patients at enrollment (T0) and one month follow-up (T1).</description>
        <time_frame>enrollment (T0) and one month follow-up (T1)</time_frame>
        <population>Missing data for one participant</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated.&#xD;
Patient-facing Diabetes Dashboard: The Patient-facing Diabetes Dashboard (also known as My Diabetes Care) is embedded within a patient web portal and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons), provides literacy level appropriate educational resources, and contains secure-messaging capability.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Diabetes Knowledge</title>
          <description>The Short Diabetes Knowledge Instrument (SDKI) was used to measure diabetes knowledge including diabetes diet, symptoms of hypoglycemia, foot care and importance of physical activity. The SDKI is a 13-item scale with scores ranging from 0 to 13 representing number of items answered correctly. The Short Diabetes Knowledge Instrument (SDKI) will be administered to all study patients at enrollment (T0) and one month follow-up (T1).</description>
          <population>Missing data for one participant</population>
          <units>score 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="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>enrollment (T0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.0" lower_limit="10" upper_limit="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>one month follow-up (T1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.0" lower_limit="10" upper_limit="12"/>
                  </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>Other</non_inferiority_type>
            <p_value>0.77</p_value>
            <method>Wilcoxon Signed Rank Sum test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Diabetes Self-Care</title>
        <description>Diabetes self-care will be measured using the Summary of Diabetes Self-Care Activities (SDSCA), an 11-item questionnaire of diabetes self-management that assess the following six aspects of the diabetes regimen: general diet (2 items), specific diet (2 items), exercise (2 items), blood-glucose testing (2 items), foot care (2 items), and smoking (1 items). Item responses use the metric &quot;days per week&quot; except for a single item about smoking status which is yes or no. Each of the five aspects (excluding smoking) is assigned a mean score based on number of days per week. The Summary of Diabetes Self-Care Activities (SDSCA) will be administered to all study patients at enrollment (T0) and one month follow-up (T1).</description>
        <time_frame>enrollment (T0) and one month follow-up (T1)</time_frame>
        <population>The overall number of participants analyzed for two blood-glucose testing items was 50, because 10 participants that do not test their blood sugar were excluded from those two items. Overall number of participants analyzed was 60 for the the other five aspects/sub-scales.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated.&#xD;
Patient-facing Diabetes Dashboard: The Patient-facing Diabetes Dashboard (also known as My Diabetes Care) is embedded within a patient web portal and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons), provides literacy level appropriate educational resources, and contains secure-messaging capability.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Diabetes Self-Care</title>
          <description>Diabetes self-care will be measured using the Summary of Diabetes Self-Care Activities (SDSCA), an 11-item questionnaire of diabetes self-management that assess the following six aspects of the diabetes regimen: general diet (2 items), specific diet (2 items), exercise (2 items), blood-glucose testing (2 items), foot care (2 items), and smoking (1 items). Item responses use the metric &quot;days per week&quot; except for a single item about smoking status which is yes or no. Each of the five aspects (excluding smoking) is assigned a mean score based on number of days per week. The Summary of Diabetes Self-Care Activities (SDSCA) will be administered to all study patients at enrollment (T0) and one month follow-up (T1).</description>
          <population>The overall number of participants analyzed for two blood-glucose testing items was 50, because 10 participants that do not test their blood sugar were excluded from those two items. Overall number of participants analyzed was 60 for the the other five aspects/sub-scales.</population>
          <units>days per week</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="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>general diet at enrollment (T0)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" lower_limit="2.8" upper_limit="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>general diet at one month follow-up (T1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" lower_limit="3.5" upper_limit="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>specific diet at enrollment (T0)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" lower_limit="2.0" upper_limit="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>specific diet at one month follow-up (T1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" lower_limit="2.5" upper_limit="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>exercise at enrollment (T0)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" lower_limit="0.5" upper_limit="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>exercise at one month follow-up (T1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" lower_limit="1.3" upper_limit="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>blood-glucose testing at enrollment (T0)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.3" lower_limit="3.0" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>blood-glucose testing at one month follow-up (T1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" lower_limit="3.0" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>foot care at enrollment (T0)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" lower_limit="1.0" upper_limit="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>foot care at one month follow-up (T1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" lower_limit="1.0" upper_limit="5.0"/>
                  </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>Analysis for pre-post change in General Diet sub-scale score</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.02</p_value>
            <method>Wilcoxon Signed Rank Sum test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Analysis for pre-post change in Specific Diet sub-scale score</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.13</p_value>
            <method>Wilcoxon Signed Rank Sum test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Analysis for pre-post change in Exercise sub-scale score</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.35</p_value>
            <method>Wilcoxon Signed Rank Sum test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Analysis for pre-post change in Blood-glucose Testing sub-scale score</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.67</p_value>
            <method>Wilcoxon Signed Rank Sum test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Analysis for pre-post change in Foot Care sub-scale score</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.65</p_value>
            <method>Wilcoxon Signed Rank Sum test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Diabetes Self-Efficacy</title>
        <description>The Perceived Diabetes Self-Management Scale (PDSMS) is a valid measure of diabetes self-efficacy. The PDSMS will be administered to all study participants at enrollment (T0) and one month follow-up (T1). Eight items are scored on a five-point Likert scale. The total PDSMS score can range from 8 to 40, with higher scores indicating more confidence in self-managing one's diabetes.</description>
        <time_frame>enrollment (T0) and one month follow-up (T1)</time_frame>
        <population>One participant had missing data.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated.&#xD;
Patient-facing Diabetes Dashboard: The Patient-facing Diabetes Dashboard (also known as My Diabetes Care) is embedded within a patient web portal and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons), provides literacy level appropriate educational resources, and contains secure-messaging capability.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Diabetes Self-Efficacy</title>
          <description>The Perceived Diabetes Self-Management Scale (PDSMS) is a valid measure of diabetes self-efficacy. The PDSMS will be administered to all study participants at enrollment (T0) and one month follow-up (T1). Eight items are scored on a five-point Likert scale. The total PDSMS score can range from 8 to 40, with higher scores indicating more confidence in self-managing one's diabetes.</description>
          <population>One participant had missing data.</population>
          <units>score 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="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>enrollment (T0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.0" lower_limit="23.0" upper_limit="30.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>one month follow-up (T1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.0" lower_limit="25.0" upper_limit="32.0"/>
                  </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>Other</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>Wilcoxon Signed Rank Sum test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Diabetes Distress</title>
        <description>The Problem Areas in Diabetes Scale (PAID-5) is a valid measure of diabetes distress. The PAID-5 will be administered to all study participants at enrollment (T0) and one month follow-up (T1). Total scores on the PAID-5 can range from 0 to 20, with higher scores suggesting greater diabetes-related emotional distress.</description>
        <time_frame>enrollment (T0) and one month follow-up (T1)</time_frame>
        <population>Missing data for one participant.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated.&#xD;
Patient-facing Diabetes Dashboard: The Patient-facing Diabetes Dashboard (also known as My Diabetes Care) is embedded within a patient web portal and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons), provides literacy level appropriate educational resources, and contains secure-messaging capability.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Diabetes Distress</title>
          <description>The Problem Areas in Diabetes Scale (PAID-5) is a valid measure of diabetes distress. The PAID-5 will be administered to all study participants at enrollment (T0) and one month follow-up (T1). Total scores on the PAID-5 can range from 0 to 20, with higher scores suggesting greater diabetes-related emotional distress.</description>
          <population>Missing data for one participant.</population>
          <units>score 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="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>enrollment (T0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" lower_limit="2.0" upper_limit="9.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>one month follow-up (T1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" lower_limit="2.0" upper_limit="9.0"/>
                  </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>Other</non_inferiority_type>
            <p_value>0.86</p_value>
            <method>Wilcoxon Signed Rank Sum test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Knowledge of Diabetes Measures</title>
        <description>Unique study specific items to assess participants' knowledge of measures of diabetes health status (e.g., Hemoglobin A1C) will be administered to all study participants at enrollment (T0) and one month follow-up (T1).</description>
        <time_frame>enrollment (T0) and one month follow-up (T1)</time_frame>
        <population>As noted in the outcome measure data table below, the number analyzed for some items is less than 60 due to missing data.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated.&#xD;
Patient-facing Diabetes Dashboard: The Patient-facing Diabetes Dashboard (also known as My Diabetes Care) is embedded within a patient web portal and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons), provides literacy level appropriate educational resources, and contains secure-messaging capability.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Knowledge of Diabetes Measures</title>
          <description>Unique study specific items to assess participants' knowledge of measures of diabetes health status (e.g., Hemoglobin A1C) will be administered to all study participants at enrollment (T0) and one month follow-up (T1).</description>
          <population>As noted in the outcome measure data table below, the number analyzed for some items is less than 60 due to missing data.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Identify definition of A1c at T0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Identify definition of A1c at T1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Identify goal range for A1c at T0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Identify goal range for A1c at T1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Identify definition of blood pressure at T0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Identify definition of blood pressure at T1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Identify goal range for blood pressure at T0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Identify goal range for blood pressure at T1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Identify definition of LDL cholesterol at T0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Identify definition of LDL cholesterol at T1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Identify goal range for LDL cholesterol at T0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Identify goal range for LDL cholesterol at T1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Identify definition of flu vaccine at T0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Identify definition of flu vaccine at T1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Identify frequency of flu vaccination at T0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Identify frequency of flu vaccination at T1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59"/>
                  </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>Analysis for pre-post change in knowledge of definition of A1C</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.30</p_value>
            <method>McNemar</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Analysis for pre-post change in knowledge of goal range for hemoglobin A1c.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>1.00</p_value>
            <method>McNemar</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Analysis for pre-post change in knowledge of definition of systolic blood pressure</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.63</p_value>
            <method>McNemar</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Analysis of pre-post change in knowledge of goal range for systolic blood pressure</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.02</p_value>
            <method>McNemar</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Analysis of pre-post change in knowledge of definition of LDL cholesterol</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.55</p_value>
            <method>McNemar</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Analysis for pre-post change in knowledge of goal range for LDL cholesterol</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0009</p_value>
            <method>McNemar</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Analysis of pre-post change in knowledge of definition of flu vaccine</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>1.00</p_value>
            <method>McNemar</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Analysis of pre-post change in knowledge of recommended frequency of flu vaccination</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>1.00</p_value>
            <method>McNemar</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Diabetes Understanding</title>
        <description>The Diabetes Care Profile (DCP) is a self-administered questionnaire that assesses the social and psychological factors related to diabetes and its treatment. The instrument includes sixteen scales. The Understanding Scale of the DCP contains 13 items that assesses respondents' perceived understanding of elements of diabetes self-care (e.g., diet for blood sugar control). We administered 9 of the 13 items to study participants, excluding items that referenced elements of self-management that are not covered in My Diabetes Care (e.g., pregnancy and diabetes). Respondents rate their understanding on a five-point Likert scale. The scale scores range from 1 to 5 and represents the average item score for the scale (∑ Q1-9/ Count of non-missing items). High scores indicate higher perceived understanding.</description>
        <time_frame>enrollment (T0) and one month follow-up (T1)</time_frame>
        <population>Missing data for one participant</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated.&#xD;
Patient-facing Diabetes Dashboard: The Patient-facing Diabetes Dashboard (also known as My Diabetes Care) is embedded within a patient web portal and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons), provides literacy level appropriate educational resources, and contains secure-messaging capability.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Diabetes Understanding</title>
          <description>The Diabetes Care Profile (DCP) is a self-administered questionnaire that assesses the social and psychological factors related to diabetes and its treatment. The instrument includes sixteen scales. The Understanding Scale of the DCP contains 13 items that assesses respondents' perceived understanding of elements of diabetes self-care (e.g., diet for blood sugar control). We administered 9 of the 13 items to study participants, excluding items that referenced elements of self-management that are not covered in My Diabetes Care (e.g., pregnancy and diabetes). Respondents rate their understanding on a five-point Likert scale. The scale scores range from 1 to 5 and represents the average item score for the scale (∑ Q1-9/ Count of non-missing items). High scores indicate higher perceived understanding.</description>
          <population>Missing data for one participant</population>
          <units>score 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="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>enrollment (T0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" lower_limit="3.0" upper_limit="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>one month follow-up (T1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7" lower_limit="3.0" upper_limit="4.0"/>
                  </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>Other</non_inferiority_type>
            <p_value>0.15</p_value>
            <method>Wilcoxon Signed Rank Sum test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Attitudes</title>
        <description>Unique study specific survey items to assess participants' attitudes toward receiving social and goal-based comparison information regarding their diabetes health status will be administered to all study participants at enrollment (T0) and one month follow-up (T1).</description>
        <time_frame>enrollment (T0) and one month follow-up (T1)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated.&#xD;
Patient-facing Diabetes Dashboard: The Patient-facing Diabetes Dashboard (also known as My Diabetes Care) is embedded within a patient web portal and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons), provides literacy level appropriate educational resources, and contains secure-messaging capability.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Attitudes</title>
          <description>Unique study specific survey items to assess participants' attitudes toward receiving social and goal-based comparison information regarding their diabetes health status will be administered to all study participants at enrollment (T0) and one month follow-up (T1).</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Interested in social comparison info at T0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Interested in social comparison info at T1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Interested goal-based comparison info at T0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Interested goal-based comparison info at T1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Agree social comparison info is useful at T0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Agree social comparison info is useful at T1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Agree goal-based comparison info is useful at T0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Agree goal-based comparison info is useful at T1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57"/>
                  </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>Analysis of pre-post change in interest in information about how my diabetes health data compares to other patients like me (i.e., social comparison information)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.23</p_value>
            <method>McNemar</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Analysis of pre-post change in interest in information about how their diabetes health data compares to the goal range (i.e., goal-based comparison information)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>1.00</p_value>
            <method>McNemar</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Analysis of pre-post change in agreement with statement: 'Information about how my diabetes health data compares to other patients like me [social comparison information] is useful.'</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.51</p_value>
            <method>McNemar</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Analysis of pre-post change in agreement with statement: 'Information about how my diabetes health data compares to the goals range [goal-based comparison information] is useful.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.63</p_value>
            <method>McNemar</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Patient Activation</title>
        <description>The Patient Activation Measure® (PAM-13) scale will be administered to all study participants at enrollment (T0) and one month follow-up (T1). The 13-item PAM® survey is a validated measure of patient activation (i.e., the knowledge, skills and confidence a person has in managing their own health and health care) and consists of 13 items. Each item uses a 4-point Likert-type scale of response options ranging from strongly disagree to strongly agree to elicit endorsement of a particular statement. PAM® survey item responses result in total raw scores ranging from 13 to 52, which we converted to the linear interval scale of patient activation scores, ranging from 0 (lowest activation) to 100 (highest activation).</description>
        <time_frame>enrollment (T0) and one month follow-up (T1)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated.&#xD;
Patient-facing Diabetes Dashboard: The Patient-facing Diabetes Dashboard (also known as My Diabetes Care) is embedded within a patient web portal and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons), provides literacy level appropriate educational resources, and contains secure-messaging capability.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Patient Activation</title>
          <description>The Patient Activation Measure® (PAM-13) scale will be administered to all study participants at enrollment (T0) and one month follow-up (T1). The 13-item PAM® survey is a validated measure of patient activation (i.e., the knowledge, skills and confidence a person has in managing their own health and health care) and consists of 13 items. Each item uses a 4-point Likert-type scale of response options ranging from strongly disagree to strongly agree to elicit endorsement of a particular statement. PAM® survey item responses result in total raw scores ranging from 13 to 52, which we converted to the linear interval scale of patient activation scores, ranging from 0 (lowest activation) to 100 (highest activation).</description>
          <units>score 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="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>enrollment (T0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.3" lower_limit="55.6" upper_limit="72.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>one month follow-up (T1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.8" lower_limit="60.6" upper_limit="75.0"/>
                  </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>Other</non_inferiority_type>
            <p_value>0.01</p_value>
            <method>Wilcoxon Signed Rank Sum test</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 month</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Intervention</title>
          <description>Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated.&#xD;
Patient-facing Diabetes Dashboard: The Patient-facing Diabetes Dashboard (also known as My Diabetes Care) is embedded within a patient web portal and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons), provides literacy level appropriate educational resources, and contains secure-messaging capability.</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="67"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="67"/>
              </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="67"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>William Martinez, MD</name_or_title>
      <organization>Vanderbilt University Medical Center</organization>
      <phone>(615) 936-1010</phone>
      <email>william.martinez@vumc.org</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/NCT03786718
org study id: 181727
secondary id: 5K23DK106511
nct id: NCT03786718
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to conduct a prospective, longitudinal study to evaluate the
      usability of a patient-facing diabetes dashboard delivered via an established patient web
      portal.
Up to 70 adult patients with type 2 diabetes mellitus will be enrolled and given access to a
      diabetes dashboard within an existing patient web portal. Patients will be invited by mail
      (or email) to be screened for enrollment in the study. Patients may also respond at a study
      flyer and contact the study team to be screened for enrollment. Eligible and interested
      patients will be emailed a link to a secure study website where they will complete a web
      consent form. After enrollment, participants will complete a baseline web-based
      questionnaire. After completing the enrollment questionnaire, they will be provided access to
      the diabetes dashboard within the patient web portal for one month. After one month,
      participants will receive an additional follow-up (final) questionnaire to assess outcomes.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Usability
time frame: one month follow-up (T1)
description: The System Usability Scale (SUS) will be administered to all study participants at one month follow-up (T1). The SUS is a validated measure of usability. The ten items are scored on a five-point Likert scale. The item scores are summed and then converted to a score ranging from 0 (worst) to 100 (best). A score of above 68 indicative of "above average" usability.
measure: User Experience - Quantitative
time frame: one month follow-up (T1)
description: User experience will be assessed by study-specific survey items administered to all study participants at the end of the study period (T1). The survey items will inquire about participants' perspectives on particular features of the Patient-facing Diabetes Dashboard. Participants were asked to indicate which features, if any: (1) they found useful for managing their diabetes and which features, (2) improved their understanding of their diabetes health data, and (3) should be removed. In addition, participants indicated whether they intended to use the dashboard going forward if it remained available.
measure: User Experience - Qualitative
time frame: one month follow-up (T1)
description: At the end of the study period (T1), a subset of study participants will be invited to complete a semi-structured interview to provide a deeper understanding of their experience using the dashboard.
measure: System Usage Data
time frame: one month follow-up (T1)
description: This is a composite outcome measure of participants' self-reported total number of diabetes dashboard visits, total duration of dashboard use, use of embedded educational links, utilization of embedded functionality to secure message healthcare team member(s), and use of an embedded link to American Diabetes Association Online Community and will be queried at the end of the study period (T1).
measure: Change in Diabetes Knowledge
time frame: enrollment (T0) and one month follow-up (T1)
description: The Short Diabetes Knowledge Instrument (SDKI) was used to measure diabetes knowledge including diabetes diet, symptoms of hypoglycemia, foot care and importance of physical activity. The SDKI is a 13-item scale with scores ranging from 0 to 13 representing number of items answered correctly. The Short Diabetes Knowledge Instrument (SDKI) will be administered to all study patients at enrollment (T0) and one month follow-up (T1).
measure: Change in Diabetes Self-Care
time frame: enrollment (T0) and one month follow-up (T1)
description: Diabetes self-care will be measured using the Summary of Diabetes Self-Care Activities (SDSCA), an 11-item questionnaire of diabetes self-management that assess the following six aspects of the diabetes regimen: general diet (2 items), specific diet (2 items), exercise (2 items), blood-glucose testing (2 items), foot care (2 items), and smoking (1 items). Item responses use the metric "days per week" except for a single item about smoking status which is yes or no. Each of the five aspects (excluding smoking) is assigned a mean score based on number of days per week. The Summary of Diabetes Self-Care Activities (SDSCA) will be administered to all study patients at enrollment (T0) and one month follow-up (T1).
measure: Change in Diabetes Self-Efficacy
time frame: enrollment (T0) and one month follow-up (T1)
description: The Perceived Diabetes Self-Management Scale (PDSMS) is a valid measure of diabetes self-efficacy. The PDSMS will be administered to all study participants at enrollment (T0) and one month follow-up (T1). Eight items are scored on a five-point Likert scale. The total PDSMS score can range from 8 to 40, with higher scores indicating more confidence in self-managing one's diabetes.
measure: Change in Diabetes Distress
time frame: enrollment (T0) and one month follow-up (T1)
description: The Problem Areas in Diabetes Scale (PAID-5) is a valid measure of diabetes distress. The PAID-5 will be administered to all study participants at enrollment (T0) and one month follow-up (T1). Total scores on the PAID-5 can range from 0 to 20, with higher scores suggesting greater diabetes-related emotional distress.
measure: Change in Knowledge of Diabetes Measures
time frame: enrollment (T0) and one month follow-up (T1)
description: Unique study specific items to assess participants' knowledge of measures of diabetes health status (e.g., Hemoglobin A1C) will be administered to all study participants at enrollment (T0) and one month follow-up (T1).
measure: Change in Diabetes Understanding
time frame: enrollment (T0) and one month follow-up (T1)
description: The Diabetes Care Profile (DCP) is a self-administered questionnaire that assesses the social and psychological factors related to diabetes and its treatment. The instrument includes sixteen scales. The Understanding Scale of the DCP contains 13 items that assesses respondents' perceived understanding of elements of diabetes self-care (e.g., diet for blood sugar control). We administered 9 of the 13 items to study participants, excluding items that referenced elements of self-management that are not covered in My Diabetes Care (e.g., pregnancy and diabetes). Respondents rate their understanding on a five-point Likert scale. The scale scores range from 1 to 5 and represents the average item score for the scale (∑ Q1-9/ Count of non-missing items). High scores indicate higher perceived understanding.
measure: Change in Attitudes
time frame: enrollment (T0) and one month follow-up (T1)
description: Unique study specific survey items to assess participants' attitudes toward receiving social and goal-based comparison information regarding their diabetes health status will be administered to all study participants at enrollment (T0) and one month follow-up (T1).
measure: Change in Patient Activation
time frame: enrollment (T0) and one month follow-up (T1)
description: The Patient Activation Measure® (PAM-13) scale will be administered to all study participants at enrollment (T0) and one month follow-up (T1). The 13-item PAM® survey is a validated measure of patient activation (i.e., the knowledge, skills and confidence a person has in managing their own health and health care) and consists of 13 items. Each item uses a 4-point Likert-type scale of response options ranging from strongly disagree to strongly agree to elicit endorsement of a particular statement. PAM® survey item responses result in total raw scores ranging from 13 to 52, which we converted to the linear interval scale of patient activation scores, ranging from 0 (lowest activation) to 100 (highest activation).
arm group label: Intervention
arm group type: Experimental
description: Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated.
intervention type: Other
intervention name: Patient-facing Diabetes Dashboard
description: The Patient-facing Diabetes Dashboard is embedded within a patient web portal and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons and gamification), provides literacy level appropriate educational resources, and contains secure-messaging capability.
arm group label: Intervention
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: William Martinez, MD, MS
role: Principal Investigator
affiliation: Vanderbilt University Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University Medical Center
investigator full name: William Martinez, MD, MS
investigator title: Assistant Professor of Medicine
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
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