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Diabetes To Go: An Inpatient Diabetes Survival Skills Education Program

Primary Purpose

Diabetes Mellitus, Hyperglycemia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
diabetes self-management education
Sponsored by
Medstar Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus focused on measuring Diabetes mellitus, Hyperglycemia, Inpatient, self-management education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • English speaking with a diabetes mellitus diagnosis (ICD 9 codes 250.xx)
  • an admitting blood glucose level of > 200 mg/dL or ≤ 40 mg/dL, and
  • an anticipated hospital stay of ≥ 2 days, as estimated by the medical staff, to allow sufficient time for delivery of program content

Exclusion Criteria:

  • pregnancy
  • admission to an intensive care unit, and
  • any medical condition or cognitive dysfunction that, in the opinion of the investigator, would preclude active participation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    diabetes self-management education

    Arm 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.

    Outcomes

    Primary Outcome Measures

    Assessment of change in Diabetes knowledge as measured by an 11-item diabetes knowledge survey
    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

    Secondary Outcome Measures

    Readmissions to the hospital and the emergency department
    Self-reported historic and post-intervention visits to ED and or admissions to the hospital
    Medication adherence (Modified Morisky Medication Adherence Scale 4-item)
    Modified Morisky Medication Adherence Scale 4-item

    Full Information

    First Posted
    May 4, 2015
    Last Updated
    August 14, 2020
    Sponsor
    Medstar Health Research Institute
    Collaborators
    Sanofi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03023228
    Brief Title
    Diabetes To Go: An Inpatient Diabetes Survival Skills Education Program
    Official Title
    Diabetes To Go: A Pilot Feasibility and Preliminary Efficacy Evaluation of an Inpatient Diabetes Self-management Survival Skills Education Program
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2010 (undefined)
    Primary Completion Date
    November 2011 (Actual)
    Study Completion Date
    November 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Medstar Health Research Institute
    Collaborators
    Sanofi

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Hyperglycemia
    Keywords
    Diabetes mellitus, Hyperglycemia, Inpatient, self-management education

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    125 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    diabetes self-management education
    Arm Type
    Experimental
    Arm 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(s)
    diabetes self-management education
    Other Intervention Name(s)
    survival skills education
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Assessment of change in Diabetes knowledge as measured by an 11-item diabetes knowledge survey
    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
    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
    Secondary Outcome Measure Information:
    Title
    Readmissions to the hospital and the emergency department
    Description
    Self-reported historic and post-intervention visits to ED and or admissions to the hospital
    Time Frame
    3 months pre- and 3 months post-intervention
    Title
    Medication adherence (Modified Morisky Medication Adherence Scale 4-item)
    Description
    Modified Morisky Medication Adherence Scale 4-item
    Time Frame
    Baseline pre intervention then at 2 weeks after intervention and at 3 months post-intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: English speaking with a diabetes mellitus diagnosis (ICD 9 codes 250.xx) an admitting blood glucose level of > 200 mg/dL or ≤ 40 mg/dL, and an anticipated hospital stay of ≥ 2 days, as estimated by the medical staff, to allow sufficient time for delivery of program content Exclusion Criteria: pregnancy admission to an intensive care unit, and any medical condition or cognitive dysfunction that, in the opinion of the investigator, would preclude active participation
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    michelle f magee, MD, MBBCh,
    Organizational Affiliation
    Medstar Health Research Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    24557596
    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.
    Results Reference
    result

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    Diabetes To Go: An Inpatient Diabetes Survival Skills Education Program

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