NCT03023228

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Timeline
Completed

Started May 2010

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2015

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

January 18, 2017

Completed
Last Updated

August 18, 2020

Status Verified

January 1, 2017

Enrollment Period

1.5 years

First QC Date

May 4, 2015

Last Update Submit

August 14, 2020

Conditions

Diabetes MellitusHyperglycemia

Keywords

Diabetes mellitusHyperglycemiaInpatientself-management education

Outcome Measures

Primary Outcomes (1)

  • 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

    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 Outcomes (2)

  • Readmissions to the hospital and the emergency department

    3 months pre- and 3 months post-intervention

  • Medication adherence (Modified Morisky Medication Adherence Scale 4-item)

    Baseline pre intervention then at 2 weeks after intervention and at 3 months post-intervention

Study Arms (1)

diabetes self-management education

EXPERIMENTAL

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

Interventions

diabetes self-management educationBEHAVIORAL

1-group, pre-test/post-test design feasibility and preliminary efficacy evaluation of diabetes survival skills self-management education delivered at the hospital bedside.

Also known as: survival skills education
diabetes self-management education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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: 24557596RESULT

MeSH Terms

Conditions

Diabetes MellitusHyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • michelle f magee, MD, MBBCh,

    Medstar Health Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2015

First Posted

January 18, 2017

Study Start

May 1, 2010

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

August 18, 2020

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share