NCT00657800

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

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
Completed

Started Dec 2007

Typical duration for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 14, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

September 22, 2010

Status Verified

September 1, 2010

Enrollment Period

1.8 years

First QC Date

April 8, 2008

Last Update Submit

September 21, 2010

Conditions

Keywords

diabetes, inpatient, education,

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

EXPERIMENTAL

Behavioral - Intensified coordinated inpatient diabetes education program (IDEP)

Behavioral: Intensified inpatient diabetes education program (IDEP)

Group 2

NO INTERVENTION

Diabetes 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)

Group 1

Eligibility Criteria

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

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

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Mary T. Korytkowski, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

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

Locations