The Effect of a Coordinated Inpatient Diabetes Education Program in the Outpatient Setting
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|ClinicalTrials.gov Identifier: NCT00657800|
Recruitment Status : Completed
First Posted : April 14, 2008
Last Update Posted : September 22, 2010
|Condition or disease||Intervention/treatment||Phase|
|Diabetes||Behavioral: Intensified inpatient diabetes education program (IDEP)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|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|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||September 2010|
Experimental: Group 1
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)
No Intervention: Group 2
Diabetes education as is typically provided by clinical staff
- Diabetes Self-Management Practices [ Time Frame: 4 months post-discharge ]
- Patient Satisfaction [ Time Frame: Discharge date, 4 months post-discharge ]
- Quality of Life (QoL) [ Time Frame: Baseline and 4 months post-discharge ]
- Glycemic and Metabolic Control [ Time Frame: 4 months post-discharge ]
- Emergency Room visits; admissions [ Time Frame: 4 months post-discharge ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00657800
|United States, Pennsylvania|
|University of Pittsburgh Department of Medicine|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Mary T. Korytkowski, MD||University of Pittsburgh|