NCT00254501

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2005

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 16, 2005

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
5.1 years until next milestone

Results Posted

Study results publicly available

July 22, 2016

Completed
Last Updated

July 22, 2016

Status Verified

July 1, 2016

Enrollment Period

5.6 years

First QC Date

November 14, 2005

Results QC Date

July 14, 2016

Last Update Submit

July 20, 2016

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 CounselingBEHAVIORAL

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 materialsBEHAVIORAL

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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: 21987530RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine 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