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Empowering Patients to Better Manage Diabetes Through Self-Care

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00254501
First Posted: November 16, 2005
Last Update Posted: July 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sanofi
Information provided by (Responsible Party):
Dale F Kraemer, University of Florida
November 14, 2005
November 16, 2005
July 14, 2016
July 22, 2016
July 22, 2016
November 2005
June 2011   (Final data collection date for primary outcome measure)
Change in Hemoglobin A-1C From Baseline [ Time Frame: baseline and 12 months ]
Compare changes in Hemoglobin A-1C from baseline between the two groups.
Change4 in Hemoglobin A-1C from baseline
Complete list of historical versions of study NCT00254501 on ClinicalTrials.gov Archive Site
  • Changes From Baseline in LDL, HDL, Total Cholesterol, Triglycerides [ Time Frame: baseline and 12 months ]

    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):

    1. LDL
    2. HDL
    3. Total cholesterol
    4. Triglycerides
  • Changes in Economic Outcomes (Total Cost of Care, Cost of Diabetes Medications, Cost of Diabetes Supplies) From Baseline to 12 Months [ Time Frame: 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:

    1. Total cost of care
    2. Costs of diabetes medications
    3. Costs of diabetes supplies
  • Change in Diabetes Knowledge and Empowerment (Patient Self-efficacy) From Baseline to 12 Months [ Time Frame: 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):

    1. 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
    2. 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.
    3. 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).
  • Cholesterol subfractions (LDL, HDL, triglycerdides)
  • Economic outcomes (total cost of care, cost of diabetes-related care, presenteeism and absenteeism, medication adherence)
  • Diabetes knowledge and empowerment (patient self-efficacy)
  • Pharmacist time spent with program
Not Provided
Not Provided
 
Empowering Patients to Better Manage Diabetes Through Self-Care
Empowering Patients to Better Manage Diabetes Through Self-Care
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.

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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Type I or Type II Diabetes (Excludes Gestational Diabetes)
  • Behavioral: 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.
  • 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.
  • Active Comparator: 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.
    Intervention: Behavioral: Educational materials
  • Experimental: 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.
    Intervention: Behavioral: Pharmacist Counseling
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
69
June 2011
June 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00254501
OSU_COP_PP_0105
IRB Application 2979
No
Not Provided
Plan to Share IPD: No
Dale F Kraemer, University of Florida
Oregon State University
Sanofi
Principal Investigator: Dale F Kraemer, Ph.D. Oregon State University, College of Pharmacy
Oregon State University
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP