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Completed

NCT Number: NCT00254501

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.

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Key information

Conditions

Type I or Type II Diabetes (Excludes Gestational Diabetes) Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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:

  • clinical markers for diabetes and related metabolic disorders;
  • the cost of care and resource utilization; and
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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):

    • LDL
    • HDL
    • Total cholesterol
    • Triglycerides

  2. 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:

    • Total cost of care
    • Costs of diabetes medications
    • Costs of diabetes supplies

  3. 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):

    • 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
    • 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.
    • 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).

Sponsors and collaborators

Lead sponsor

Oregon State University

Other

Collaborators

  • Sanofi

Registry information

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Nov 16, 2005
Registry last updated
Jul 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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