Diabetes To Go: An Inpatient Diabetes Survival Skills Education Program

August 14, 2020 updated by: Medstar Health Research Institute

Diabetes To Go: A Pilot Feasibility and Preliminary Efficacy Evaluation of an Inpatient Diabetes Self-management Survival Skills Education Program

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

125

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • survival skills education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Measures

Outcome Measure
Measure Description
Time Frame
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
3 months pre- and 3 months post-intervention
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
Baseline pre intervention then at 2 weeks after intervention and at 3 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medstar Health Research Institute

Collaborators

Sanofi

Investigators

  • Principal Investigator: michelle f magee, MD, MBBCh,, MedStar Health Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

May 4, 2015

First Submitted That Met QC Criteria

January 13, 2017

First Posted (Estimate)

January 18, 2017

Study Record Updates

Last Update Posted (Actual)

August 18, 2020

Last Update Submitted That Met QC Criteria

August 14, 2020

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-354

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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