This study will look at the impact of health insurance benefits on self management of diabetes for people with this condition. Studies have shown that when people with diabetes manage their disease better, they stay healthier. Our goal in this study is to help those with diabetes better manage their disease (self-care). We will compare two types of health insurance benefits in this study. We want to see if one set of benefits improves self-care more than the other one.

Condition	Intervention
Type I or Type II Diabetes (Excludes Gestational Diabetes)	Behavior: Regularly-scheduled consulting session with pharmacists

Further study details as provided by Oregon State University:

Primary Outcomes: Change4 in Hemoglobin A-1C from baseline
Secondary Outcomes: Cholesterol subfractions (LDL, HDL, triglycerdides); Economic outcomes (total cost of care, cost of diabetes-related care, presenteeism and absenteeism, medication adherence); Diabetes knowledge and empowerment (patient self-efficacy); Pharmacist time spent with program
Expected Total Enrollment:  300

The objective of this particular study is to determine if the addition of regular pharmacist visits to usual care can improve clinical outcomes in patients with diabetes. The central hypothesis is that a program overseen by community pharmacists that empowers patients to self-manage their diabetes will lead to improved clinical and humanistic outcomes and will be cost-effective. Strong preliminary data collected from other sites suggests that patient empowerment programs are effective at reducing hemoglobin A1C after 12 months and in reducing the total cost of care. This hypothesis will be tested by pursuing three specific aims to evaluate the impact of a pharmacist-administered diabetes patient empowerment program on:

• 1) clinical markers for diabetes and related metabolic disorders;
• 2) the cost of care and resource utilization; and
• 3) patient knowledge and perceived ability to manage diabetes. There is an additional specific aim to assess the pharmacists with respect to satisfaction with the training program and the overall project, the activities conducted in patient sessions, and the time taken to complete the visits in this study.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• diabetes (Type I or Type II)
• enrolled in health plan with participating employer
• age 18 or older
• willing and able to provide informed consent

Exclusion Criteria:

• gestational diabetes

Please refer to this study by ClinicalTrials.gov identifier  NCT00254501

Dale F Kraemer, Ph.D.      503-494-2258    kraemerd@ohsu.edu
Terri M Bianco, Pharm.D      503-494-1595    biancot@ohsu.edu

Oregon
      Department of Pharmacy Practice, Oregon State University, Portland,  Oregon,  97239-2985,  United States

Study chairs or principal investigators

Dale F Kraemer, Ph.D.,  Principal Investigator,  Oregon State University, College of Pharmacy   

Study ID Numbers:  OSU_COP_PP_0105; IRB Application 2979
Last Updated:  December 8, 2005
Record first received:  November 14, 2005
ClinicalTrials.gov Identifier:  NCT00254501
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2006-01-10