Clinical trial NCT00254501: Empowering Patients to Better Manage Diabetes Through Self-Care
Official title: Empowering Patients to Better Manage Diabetes Through Self-Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type I or Type II Diabetes (Excludes Gestational Diabetes)
Keywords: diabetes
Lead sponsor: Oregon State University
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2005-11-16
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Change in Hemoglobin A-1C From Baseline
timeFrame: baseline and 12 months
Secondary outcomes:
measure: Changes From Baseline in LDL, HDL, Total Cholesterol, Triglycerides
timeFrame: baseline and 12 months
measure: Changes in Economic Outcomes (Total Cost of Care, Cost of Diabetes Medications, Cost of Diabetes Supplies) From Baseline to 12 Months
timeFrame: baseline to 12 months
measure: Change in Diabetes Knowledge and Empowerment (Patient Self-efficacy) From Baseline to 12 Months
timeFrame: From baseline to 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Oregon State University, College of Pharmacy
name: Dale F Kraemer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kraemer DF, Kradjan WA, Bianco TM, Low JA. A randomized study to assess the impact of pharmacist counseling of employer-based health plan beneficiaries with diabetes: the EMPOWER study. J Pharm Pract. 2012 Apr;25(2):169-79. doi: 10.1177/0897190011418513. Epub 2011 Oct 10.