Empowering Patients to Better Manage Diabetes Through Self-Care

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Dale F Kraemer, University of Florida
ClinicalTrials.gov Identifier:
NCT00254501
First received: November 14, 2005
Last updated: July 20, 2016
Last verified: July 2016
  Purpose
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.

Condition Intervention Phase
Type I or Type II Diabetes (Excludes Gestational Diabetes)
Behavioral: Pharmacist Counseling
Behavioral: Educational materials
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Empowering Patients to Better Manage Diabetes Through Self-Care

Further study details as provided by Oregon State University:

Primary Outcome Measures:
  • Change in Hemoglobin A-1C From Baseline [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    Compare changes in Hemoglobin A-1C from baseline between the two groups.


Secondary Outcome Measures:
  • Changes From Baseline in LDL, HDL, Total Cholesterol, Triglycerides [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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).


Enrollment: 69
Study Start Date: November 2005
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00254501

Sponsors and Collaborators
Oregon State University
Sanofi
Investigators
Principal Investigator: Dale F Kraemer, Ph.D. Oregon State University, College of Pharmacy
  More Information

Publications:
Responsible Party: Dale F Kraemer, Associate Professor, University of Florida
ClinicalTrials.gov Identifier: NCT00254501     History of Changes
Other Study ID Numbers: OSU_COP_PP_0105  IRB Application 2979 
Study First Received: November 14, 2005
Results First Received: July 14, 2016
Last Updated: July 20, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Oregon State University:
diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on July 28, 2016