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Diabetes To Go: An Inpatient Diabetes Survival Skills Education Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03023228
Recruitment Status : Completed
First Posted : January 18, 2017
Last Update Posted : August 18, 2020
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Medstar Health Research Institute

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Hyperglycemia Behavioral: diabetes self-management education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Diabetes To Go: A Pilot Feasibility and Preliminary Efficacy Evaluation of an Inpatient Diabetes Self-management Survival Skills Education Program
Study Start Date : May 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: diabetes self-management education
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.
Behavioral: diabetes self-management education
1-group, pre-test/post-test design feasibility and preliminary efficacy evaluation of diabetes survival skills self-management education delivered at the hospital bedside.
Other Name: survival skills education




Primary Outcome Measures :
  1. 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 ]
    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 :
  1. Readmissions to the hospital and the emergency department [ Time Frame: 3 months pre- and 3 months post-intervention ]
    Self-reported historic and post-intervention visits to ED and or admissions to the hospital

  2. 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 ]
    Modified Morisky Medication Adherence Scale 4-item



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03023228


Sponsors and Collaborators
Medstar Health Research Institute
Sanofi
Investigators
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Principal Investigator: michelle f magee, MD, MBBCh, Medstar Health Research Institute
  Study Documents (Full-Text)

Documents provided by Medstar Health Research Institute:
Informed Consent Form  [PDF] January 27, 2016

Publications of Results:
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Responsible Party: Medstar Health Research Institute
ClinicalTrials.gov Identifier: NCT03023228    
Other Study ID Numbers: 2009-354
First Posted: January 18, 2017    Key Record Dates
Last Update Posted: August 18, 2020
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Medstar Health Research Institute:
Diabetes mellitus
Hyperglycemia
Inpatient
self-management education
Additional relevant MeSH terms:
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Diabetes Mellitus
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases