Empowering Patients to Better Manage Diabetes Through Self-Care

Oregon State University (OSU)

Status and phase: Completed; Phase 3

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

Treatments: Behavioral: Educational materials; Behavioral: Pharmacist Counseling

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00254501

IRB Application 2979

OSU_COP_PP_0105

Details and patient eligibility

About

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.

Full 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.

Enrollment: 69 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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69 participants in 2 patient groups

Usual Care plus out-of-pocket cost waiver

Active Comparator group

Description:

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.

Treatment:

Behavioral: Educational materials

EMPOWER

Experimental group

Description:

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.

Treatment:

Behavioral: Pharmacist Counseling