Empowering Patients to Better Manage Diabetes Through Self-Care

NCT00254501 | Completed Phase 3 Results

• 2 other identifiers: OSU_COP_PP_0105IRB Application 2979
• Study Type: interventional
• Target: 69
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type I or Type II Diabetes (Excludes Gestational Diabetes)

Keywords

diabetes

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin A-1C From Baseline

  Compare changes in Hemoglobin A-1C from baseline between the two groups.

  baseline and 12 months

Secondary Outcomes (3)

• Changes From Baseline in 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

  baseline to 12 months

• Change in Diabetes Knowledge and Empowerment (Patient Self-efficacy) From Baseline to 12 Months

  From baseline to 12 months

Study Arms (2)

Usual Care plus out-of-pocket cost waiver

ACTIVE COMPARATOR

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

EMPOWER

EXPERIMENTAL

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

Interventions

Pharmacist Counseling 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.

EMPOWER

Educational materials 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.

Usual Care plus out-of-pocket cost waiver

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diabetes (Type I or Type II)
• enrolled in health plan with participating employer
• age 18 or older
• willing and able to provide informed consent

You may not qualify if:

• gestational diabetes

Sponsors & Collaborators

• Oregon State University: lead
• Sanofi: collaborator

Related Publications (1)

• 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.

  PMID: 21987530 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dale Kraemer
• Organization: University of Florida

Dale.Kraemer@jax.ufl.edu

Study Officials

• Dale F Kraemer, Ph.D.

  Oregon State University, College of Pharmacy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 14, 2005
• First Posted: November 16, 2005
• Study Start: November 1, 2005
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: July 22, 2016
• Results First Posted: July 22, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share