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| Sponsored by: |
University of Pittsburgh |
|---|---|
| Information provided by: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00657800 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Diabetes |
Behavioral: Intensified inpatient diabetes education program (IDEP) |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Open Label, Parallel Assignment, Efficacy Study |
| Official Title: | The Effect of a Coordinated Inpatient Diabetes Education Program on Glycemic Control, Diabetes Self-Management, Patient Satisfaction, and Quality of Life in the Outpatient Setting |
| Estimated Enrollment: | 60 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Group 1: Experimental
Behavioral - Intensified coordinated inpatient diabetes education program (IDEP)
|
Behavioral: Intensified inpatient diabetes education program (IDEP)
Assessment of educational needs and coordination of inpatient unit based education program by Certified Diabetes Educator (CDE)
|
|
Group 2: No Intervention
Diabetes education as is typically provided by clinical staff
|
Patients will be recruited from matched sets of inpatient units determined to be comparable in terms of staffing and types of patients admitted. One unit from each matched set will be selected as the intervention unit (Group 1) or the control unit (Group 2) as determined by a random draw.
Group 1 patients will receive the coordinated inpatient diabetes education program (IDEP). Patients will be initially evaluated by a certified diabetes educator (CDE) to assess diabetes knowledge and to set priorities for "survival skills" education. Based on this individualized evaluation, a structured education plan will be devised and implemented by the CDE. The structured education plan will be modified as needed throughout the hospital stay to utilize more appropriate educational methods based on patient availability, condition or educational needs.
Group 2 (Control) will receive diabetes education as it is presently provided in our facility by the clinical staff. The staff nurse will be alerted that the patient is a participant in the research study and will record education provided in the electronic medical records.
The modified Michigan Diabetes Research and Training Center's Brief Diabetes Knowledge Test (DKT) and the Diabetes Treatment Satisfaction Questionnaire (DTSQs), if diabetes was pre-existing, will be administered initially to all patients by a member of the research team. If appropriate, the patient will be asked by the research team to complete a Quality of Life Survey (The Medical Outcomes Survey (MOS) Short-Form 36 (SF-36) General Health Survey prior to discharge. Completion of the Diabetes Treatment Satisfaction Questionnaire - Inpatient (DTSQ-IP) will also be requested of the patient prior to discharge.
All participants will be contacted 4 months after discharge for a similar assessment of quality of life and patient satisfaction with diabetes treatment, and for an additional assessment of diabetes self-management practices which includes the number of emergency room visits and readmissions since discharge. Comparisons will be made between the two groups and between baseline and follow-up assessments.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Pennsylvania | |
| University of Pittsburgh Department of Medicine | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Principal Investigator: | Mary T. Korytkowski, MD | University of Pittsburgh |
More Information
| Responsible Party: | University of Pittsburgh ( Mary T. Korytkowski ) |
| Study ID Numbers: | PRO07030238 |
| Study First Received: | April 8, 2008 |
| Last Updated: | October 15, 2008 |
| ClinicalTrials.gov Identifier: | NCT00657800 |
| Health Authority: | United States: Institutional Review Board |
|
diabetes, inpatient, education, |
|
Metabolic Diseases Diabetes Mellitus Quality of Life Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |
