The Effect of a Coordinated Inpatient Diabetes Education Program in the Outpatient Setting
1 other identifier
interventional
60
1 country
1
Brief Summary
Patients will be recruited from comparable inpatient units that have been randomized as either interventional (Group 1) or control (Group 2) units. Patients in the interventional group will receive a comprehensive individualized diabetes education program coordinated by a certified diabetes educator. Patients in Group 2 will receive education from clinical staff as it is typically provided. Assessment of patient satisfaction with both inpatient and outpatient care, quality of life, and diabetes self-management skills (including emergency room visits and readmissions) will be measured using surveys completed during hospitalization and 4 months after discharge to determine any differences between the two groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes
Started Dec 2007
Typical duration for not_applicable diabetes
1 active site
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
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 8, 2008
CompletedFirst Posted
Study publicly available on registry
April 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedSeptember 22, 2010
September 1, 2010
1.8 years
April 8, 2008
September 21, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Diabetes Self-Management Practices
4 months post-discharge
Patient Satisfaction
Discharge date, 4 months post-discharge
Quality of Life (QoL)
Baseline and 4 months post-discharge
Secondary Outcomes (2)
Glycemic and Metabolic Control
4 months post-discharge
Emergency Room visits; admissions
4 months post-discharge
Study Arms (2)
Group 1
EXPERIMENTALBehavioral - Intensified coordinated inpatient diabetes education program (IDEP)
Group 2
NO INTERVENTIONDiabetes education as is typically provided by clinical staff
Interventions
Assessment of educational needs and coordination of inpatient unit based education program by Certified Diabetes Educator (CDE)
Eligibility Criteria
You may qualify if:
- Hospitalized patients with diabetes as defined by ADA criteria
- Ability to understand informed consent document
- Community-dwelling adults
You may not qualify if:
- Patients using CSII (continuous subcutaneous insulin infusion)
- Patients with Do Not Resuscitate (DNR) orders
- Decisionally impaired patients
- Patients admitted for 24 hour observation
- Patients in Intensive Care settings
- Patients with language barriers or sensory deficits mandating the need for specialized instruction
- Patients who are pregnant
- Patients for whom transfer to a skilled nursing or other assisted care living facilities is anticipated after discharge.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pittsburgh Department of Medicine
Pittsburgh, Pennsylvania, 15213, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mary T. Korytkowski, MD
University of Pittsburgh
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 8, 2008
First Posted
April 14, 2008
Study Start
December 1, 2007
Primary Completion
October 1, 2009
Study Completion
September 1, 2010
Last Updated
September 22, 2010
Record last verified: 2010-09