<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/NCT03023228</url>
  </required_header>
  <id_info>
    <org_study_id>2009-354</org_study_id>
    <nct_id>NCT03023228</nct_id>
  </id_info>
  <brief_title>Diabetes To Go: An Inpatient Diabetes Survival Skills Education Program</brief_title>
  <official_title>Diabetes To Go: A Pilot Feasibility and Preliminary Efficacy Evaluation of an Inpatient Diabetes Self-management Survival Skills Education Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medstar Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Medstar Health Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A learner-centered diabetes survival skills self-management education program was provided to&#xD;
      adults with uncontrolled diabetes in the hospital and generated preliminary evidence of&#xD;
      impact on medication adherence and a trend toward reduction in hospital and emergency&#xD;
      department admissions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was a prospective, nonrandomized pilot study conducted among adults with&#xD;
      uncontrolled diabetes admitted to the Medicine Service of an urban tertiary teaching hospital&#xD;
      were consented to participate in a pilot study which provided diabetes survival skills&#xD;
      education. Based on knowledge deficits identified on a diabetes knowledge pre-test the&#xD;
      patient was directed to view video content corresponding to those deficiencies and content on&#xD;
      sick days and diabetes complications. Evaluation measures were diabetes knowledge, medication&#xD;
      adherence, and hospital admissions plus emergency department visits at and/or 3months before&#xD;
      baseline and at 2 weeks and 3 months post-discharge. There was improvement in diabetes&#xD;
      knowledge and medication adherence, which was sustained to 3 months. A trend was observed&#xD;
      toward reduction in emergency department and/or hospital admissions from 3 months&#xD;
      pre-intervention to 3 months post-discharge for uncontrolled diabetes. This knowledge-based&#xD;
      program successfully provided survival skills education to hospital patients with&#xD;
      uncontrolled diabetes and demonstrated preliminary evidence of a positive impact on&#xD;
      medication adherence and a trend toward reduction in hospital and emergency department&#xD;
      admissions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2010</start_date>
  <completion_date type="Actual">November 2011</completion_date>
  <primary_completion_date type="Actual">November 2011</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>Assessment of change in Diabetes knowledge as measured by an 11-item diabetes knowledge survey</measure>
    <time_frame>Baseline score obtained before receiving the education intervention. Post test score obtained immediately after the education intervention was completed during the hospital stay, usually within 24 hours or less from the baseline score</time_frame>
    <description>11-item diabetes knowledge survey administered pre- and post- education intervention during the same hospital stay. Baseline score and post intervention score obtained within a 24 hour period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Readmissions to the hospital and the emergency department</measure>
    <time_frame>3 months pre- and 3 months post-intervention</time_frame>
    <description>Self-reported historic and post-intervention visits to ED and or admissions to the hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication adherence (Modified Morisky Medication Adherence Scale 4-item)</measure>
    <time_frame>Baseline pre intervention then at 2 weeks after intervention and at 3 months post-intervention</time_frame>
    <description>Modified Morisky Medication Adherence Scale 4-item</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">125</enrollment>
  <condition>Diabetes Mellitus</condition>
  <condition>Hyperglycemia</condition>
  <arm_group>
    <arm_group_label>diabetes self-management education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Diabetes survival skills self-management education (DSME) program content was aligned with American Diabetes Association and Joint Commission suggested key areas for hospital diabetes education. Content areas were as follows: when and how to take diabetes medications; glycemic goals and self-blood glucose monitoring; definition, prevention, recognition, and treatment of hypoglycemia and hyperglycemia; what to do before you see the dietitian; sick day management; and when to call the doctor or go to the ED. Program content was created for delivery via either DVD or print format.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>diabetes self-management education</intervention_name>
    <description>1-group, pre-test/post-test design feasibility and preliminary efficacy evaluation of diabetes survival skills self-management education delivered at the hospital bedside.</description>
    <arm_group_label>diabetes self-management education</arm_group_label>
    <other_name>survival skills education</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English speaking with a diabetes mellitus diagnosis (ICD 9 codes 250.xx)&#xD;
&#xD;
          -  an admitting blood glucose level of &gt; 200 mg/dL or ≤ 40 mg/dL, and&#xD;
&#xD;
          -  an anticipated hospital stay of ≥ 2 days, as estimated by the medical staff, to allow&#xD;
             sufficient time for delivery of program content&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  admission to an intensive care unit, and&#xD;
&#xD;
          -  any medical condition or cognitive dysfunction that, in the opinion of the&#xD;
             investigator, would preclude active participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>michelle f magee, MD, MBBCh,</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medstar Health Research Institute</affiliation>
  </overall_official>
  <results_reference>
    <citation>Magee MF, Khan NH, Desale S, Nassar CM. Diabetes to Go: Knowledge- and Competency-Based Hospital Survival Skills Diabetes Education Program Improves Postdischarge Medication Adherence. Diabetes Educ. 2014 May;40(3):344-350. doi: 10.1177/0145721714523684. Epub 2014 Feb 20.</citation>
    <PMID>24557596</PMID>
  </results_reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>May 4, 2015</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>August 14, 2020</last_update_submitted>
  <last_update_submitted_qc>August 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diabetes mellitus</keyword>
  <keyword>Hyperglycemia</keyword>
  <keyword>Inpatient</keyword>
  <keyword>self-management education</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Hyperglycemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <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>January 27, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT03023228/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03023228
org study id: 2009-354
nct id: NCT03023228
lead sponsor: 
collaborator: 
has dmc: No
A learner-centered diabetes survival skills self-management education program was provided to
      adults with uncontrolled diabetes in the hospital and generated preliminary evidence of
      impact on medication adherence and a trend toward reduction in hospital and emergency
      department admissions.
This study was a prospective, nonrandomized pilot study conducted among adults with
      uncontrolled diabetes admitted to the Medicine Service of an urban tertiary teaching hospital
      were consented to participate in a pilot study which provided diabetes survival skills
      education. Based on knowledge deficits identified on a diabetes knowledge pre-test the
      patient was directed to view video content corresponding to those deficiencies and content on
      sick days and diabetes complications. Evaluation measures were diabetes knowledge, medication
      adherence, and hospital admissions plus emergency department visits at and/or 3months before
      baseline and at 2 weeks and 3 months post-discharge. There was improvement in diabetes
      knowledge and medication adherence, which was sustained to 3 months. A trend was observed
      toward reduction in emergency department and/or hospital admissions from 3 months
      pre-intervention to 3 months post-discharge for uncontrolled diabetes. This knowledge-based
      program successfully provided survival skills education to hospital patients with
      uncontrolled diabetes and demonstrated preliminary evidence of a positive impact on
      medication adherence and a trend toward reduction in hospital and emergency department
      admissions.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Assessment of change in Diabetes knowledge as measured by an 11-item diabetes knowledge survey
time frame: Baseline score obtained before receiving the education intervention. Post test score obtained immediately after the education intervention was completed during the hospital stay, usually within 24 hours or less from the baseline score
description: 11-item diabetes knowledge survey administered pre- and post- education intervention during the same hospital stay. Baseline score and post intervention score obtained within a 24 hour period
measure: Readmissions to the hospital and the emergency department
time frame: 3 months pre- and 3 months post-intervention
description: Self-reported historic and post-intervention visits to ED and or admissions to the hospital
measure: Medication adherence (Modified Morisky Medication Adherence Scale 4-item)
time frame: Baseline pre intervention then at 2 weeks after intervention and at 3 months post-intervention
description: Modified Morisky Medication Adherence Scale 4-item
arm group label: diabetes self-management education
arm group type: Experimental
description: Diabetes survival skills self-management education (DSME) program content was aligned with American Diabetes Association and Joint Commission suggested key areas for hospital diabetes education. Content areas were as follows: when and how to take diabetes medications; glycemic goals and self-blood glucose monitoring; definition, prevention, recognition, and treatment of hypoglycemia and hyperglycemia; what to do before you see the dietitian; sick day management; and when to call the doctor or go to the ED. Program content was created for delivery via either DVD or print format.
intervention type: Behavioral
intervention name: diabetes self-management education
description: 1-group, pre-test/post-test design feasibility and preliminary efficacy evaluation of diabetes survival skills self-management education delivered at the hospital bedside.
arm group label: diabetes self-management education
other name: survival skills education
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: michelle f magee, MD, MBBCh,
role: Principal Investigator
affiliation: Medstar Health Research Institute
citation: Magee MF, Khan NH, Desale S, Nassar CM. Diabetes to Go: Knowledge- and Competency-Based Hospital Survival Skills Diabetes Education Program Improves Postdischarge Medication Adherence. Diabetes Educ. 2014 May;40(3):344-350. doi: 10.1177/0145721714523684. Epub 2014 Feb 20.
PMID: 24557596
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Hyperglycemia
sharing ipd: No
provided document: 