Empowering Patients to Better Manage Diabetes Through Self-Care

Study Overview
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Brief Summary
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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
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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.

Official Title
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Empowering Patients to Better Manage Diabetes Through Self-Care

Conditions
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Type I or Type II Diabetes (Excludes Gestational Diabetes)

Intervention / Treatment
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* Behavioral: Pharmacist Counseling
* Behavioral: Educational materials


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care plus out-of-pocket cost waiver<br>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. | Behavioral: Educational materials<br>* 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.<br>|
| Experimental: EMPOWER<br>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. | Behavioral: Pharmacist Counseling<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hemoglobin A-1C From Baseline | 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 | 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): LDL HDL Total cholesterol Triglycerides | 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 | 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: Total cost of care Costs of diabetes medications Costs of diabetes supplies | baseline to 12 months | 
| Change in Diabetes Knowledge and Empowerment (Patient Self-efficacy) 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): Changes from baseline to 12 months for the Diabetes Empowerment Scale (DES). Mean score for 28 items each scored as a Likert scale from 1 to 5. Higher scores correspond to greater empowerment Changes from baseline to 12 months for the Adherence Starts with Knowledge (ASK-20) adherence barrier test total barrier score (TBC). The TBC has a range from 0 to 18 and higher scores correspond to greater barriers. Changes from baseline to 12 months for understanding of diabetes. This is a single question: How would you rate your understanding of diabetes and its treatment? which uses a 7-point scale Likert scale as the response from 1 (poor) to 7 (excellent). | From baseline to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes