Clinical trial NCT03023228: Diabetes To Go: An Inpatient Diabetes Survival Skills Education Program
Official title: Diabetes To Go: A Pilot Feasibility and Preliminary Efficacy Evaluation of an Inpatient Diabetes Self-management Survival Skills Education Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Hyperglycemia
Keywords: Diabetes mellitus
Hyperglycemia
Inpatient
self-management education
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2017-01-18
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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

Primary outcomes:
measure: Assessment of change in Diabetes knowledge as measured by an 11-item diabetes knowledge survey
timeFrame: 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:
measure: Readmissions to the hospital and the emergency department
timeFrame: 3 months pre- and 3 months post-intervention
measure: Medication adherence (Modified Morisky Medication Adherence Scale 4-item)
timeFrame: Baseline pre intervention then at 2 weeks after intervention and at 3 months post-intervention
Other outcomes:
Locations:
Study officials:
affiliation: Medstar Health Research Institute
name: michelle f magee, MD, MBBCh,
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.