<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/NCT02988427</url>
  </required_header>
  <id_info>
    <org_study_id>STU00203715</org_study_id>
    <nct_id>NCT02988427</nct_id>
  </id_info>
  <brief_title>Measuring Patient Engagement in Diabetes Care</brief_title>
  <official_title>Measuring Patient Engagement in Diabetes Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of North Carolina</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Northwestern University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      We will develop a new measure of patient engagement/activation specific to the context of&#xD;
      diabetes self-care&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Anticipated">December 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Diabetes Self-efficacy</measure>
    <time_frame>Baseline</time_frame>
    <description>Self-efficacy will be assessed using an 8-item measure developed by Sarkar and colleagues asking respondents to rate their confidence in their ability to perform individual diabetes self-care activities, such as monitoring their blood glucose, getting medical attention, and taking care of their health.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diabetes Distress</measure>
    <time_frame>Baseline</time_frame>
    <description>The Diabetes Distress Scale (DDS) is a 17-item measure of diabetes-related emotional distress. It has four subscales corresponding to emotional burden, physician-related distress, regimen distress, and diabetes interpersonal distress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Health Status</measure>
    <time_frame>Baseline</time_frame>
    <description>Patient-Reported Outcomes Measurement Information System (PROMIS) is a national resource providing state-of-the-art tools for assessing patient symptoms and health outcomes. Short form measures of physical health (function) and emotional health (depression, anxiety) will be collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Outcomes</measure>
    <time_frame>3 months before baseline to 3 months after baseline</time_frame>
    <description>Hemoglobin A1c (HbA1c) and LDL cholesterol lab values, along with systolic and diastolic blood pressure values are collected as part of routine clinical care at every 3 months, and will be recorded from the medical record from the most recent visit.</description>
  </secondary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Diabetes Mellitus, Type II</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Diabetic patients ages 21 and older will be recruited from study clinics&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient is age 21 and older&#xD;
&#xD;
          2. Patient is English speaking&#xD;
&#xD;
          3. Patient has been diagnosed with Type II Diabetes by a health care provider&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Severe, uncorrectable vision&#xD;
&#xD;
          2. Hearing impairments&#xD;
&#xD;
          3. Cognitive impairment&#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>Michael Wolf, PhD, MPH, MA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Stacy Bailey, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina</affiliation>
  </overall_official>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>March 13, 2017</last_update_submitted>
  <last_update_submitted_qc>March 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02988427
org study id: STU00203715
nct id: NCT02988427
lead sponsor: 
collaborator: 
has dmc: No
We will develop a new measure of patient engagement/activation specific to the context of
      diabetes self-care
observational model: Case-Control
time perspective: Cross-Sectional
measure: Diabetes Self-efficacy
time frame: Baseline
description: Self-efficacy will be assessed using an 8-item measure developed by Sarkar and colleagues asking respondents to rate their confidence in their ability to perform individual diabetes self-care activities, such as monitoring their blood glucose, getting medical attention, and taking care of their health.
measure: Diabetes Distress
time frame: Baseline
description: The Diabetes Distress Scale (DDS) is a 17-item measure of diabetes-related emotional distress. It has four subscales corresponding to emotional burden, physician-related distress, regimen distress, and diabetes interpersonal distress.
measure: Functional Health Status
time frame: Baseline
description: Patient-Reported Outcomes Measurement Information System (PROMIS) is a national resource providing state-of-the-art tools for assessing patient symptoms and health outcomes. Short form measures of physical health (function) and emotional health (depression, anxiety) will be collected.
measure: Clinical Outcomes
time frame: 3 months before baseline to 3 months after baseline
description: Hemoglobin A1c (HbA1c) and LDL cholesterol lab values, along with systolic and diastolic blood pressure values are collected as part of routine clinical care at every 3 months, and will be recorded from the medical record from the most recent visit.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Wolf, PhD, MPH, MA
role: Principal Investigator
affiliation: Northwestern University
last name: Stacy Bailey, PhD, MPH
role: Principal Investigator
affiliation: University of North Carolina
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No