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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03023228
Other study ID # 2009-354
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2010
Est. completion date November 2011

Study information

Verified date January 2017
Source Medstar Health Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 125
Est. completion date November 2011
Est. primary completion date November 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Medstar Health Research Institute Sanofi

References & 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. Epub 2014 Feb 20. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Readmissions to the hospital and the emergency department Self-reported historic and post-intervention visits to ED and or admissions to the hospital 3 months pre- and 3 months post-intervention
Secondary Medication adherence (Modified Morisky Medication Adherence Scale 4-item) Modified Morisky Medication Adherence Scale 4-item Baseline pre intervention then at 2 weeks after intervention and at 3 months post-intervention
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