Diabetes Mellitus Clinical Trial
Official title:
Diabetes To Go: A Pilot Feasibility and Preliminary Efficacy Evaluation of an Inpatient Diabetes Self-management Survival Skills Education Program
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 |
Verified date | January 2017 |
Source | Medstar Health Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Medstar Health Research Institute | Sanofi |
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
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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