- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00254501
Empowering Patients to Better Manage Diabetes Through Self-Care
Study Overview
Status
Intervention / Treatment
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:
- clinical markers for diabetes and related metabolic disorders;
- the cost of care and resource utilization; and
- 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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Usual Care plus out-of-pocket cost waiver
Patients received educational materials (handouts) in the mail.
This was assumed to be of minimal effectiveness.
Patients also received waiver of out-of-pocket expenses for diabetes care.
|
Patients received educational materials (handouts) in the mail.
This was assumed to be of minimal effectiveness.
Patients also received waiver of out-of-pocket expenses for diabetes care.
|
Experimental: EMPOWER
Patients were scheduled for free counseling with pharmacists including medication, diet, and other self-management items.
Patients also received waiver of out-of-pocket expenses for diabetes care.
|
Patients were scheduled for free counseling with pharmacists including medication, diet, and other self-management items.
Patients also received waiver of out-of-pocket expenses for diabetes care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Hemoglobin A-1C From Baseline
Time Frame: baseline and 12 months
|
Compare changes in Hemoglobin A-1C from baseline between the two groups.
|
baseline and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes From Baseline in LDL, HDL, Total Cholesterol, Triglycerides
Time Frame: baseline and 12 months
|
Changes from baseline in LDL, HDL, total cholesterol, triglycerides. Sample sizes for each individual test (usual care plus out-of-pocket cost waiver; EMPOWER group):
|
baseline and 12 months
|
Changes in Economic Outcomes (Total Cost of Care, Cost of Diabetes Medications, Cost of Diabetes Supplies) From Baseline to 12 Months
Time Frame: baseline to 12 months
|
Changes in claims-based economic data on costs of total health care, diabetes medications, and diabetes supplies from baseline to 12 months. Only participants who had a claim in the 12 months prior to baseline were included in these analyses. The resulting sample sizes (usual care plus out-of-pocket cost waiver; EMPOWER group) for these outcomes are:
|
baseline to 12 months
|
Change in Diabetes Knowledge and Empowerment (Patient Self-efficacy) From Baseline to 12 Months
Time Frame: From baseline to 12 months
|
Psycho-social aspects of diabetes knowledge and empowerment. Sample sizes are in parentheses (usual care plus out-of-pocket cost waiver; EMPOWER group):
|
From baseline to 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Dale F Kraemer, Ph.D., Oregon State University, College of Pharmacy
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OSU_COP_PP_0105
- IRB Application 2979
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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