Empowering Patients to Better Manage Diabetes Through Self-Care

NCT ID: NCT00254501

Last Updated: 2016-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2011-06-30

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.

Conditions

Type I or Type II Diabetes (Excludes Gestational Diabetes)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Educational materials

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Pharmacist Counseling

Intervention Type: BEHAVIORAL

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.

Interventions

Pharmacist Counseling

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.

Intervention Type: BEHAVIORAL

Educational materials

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Oregon State University

OTHER

Sponsor Role: lead

Responsible Party

Dale F Kraemer

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dale F Kraemer, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Oregon State University, College of Pharmacy

References

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.

Reference Type: RESULT

PMID: 21987530 (View on PubMed)

Other Identifiers

IRB Application 2979

Identifier Type: -

Identifier Source: secondary_id

OSU_COP_PP_0105

Identifier Type: -

Identifier Source: org_study_id