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Empowering Patients to Better Manage Diabetes Through Self-Care

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Oregon State University
ClinicalTrials.gov Identifier:
NCT00254501
First received: November 14, 2005
Last updated: October 18, 2012
Last verified: October 2012
History of Changes
  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
Type I or Type II Diabetes (Excludes Gestational Diabetes)
 Behavioral: Regularly-scheduled consulting session with pharmacists

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oregon State University:

Primary Outcome Measures:
  • Change4 in Hemoglobin A-1C from baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cholesterol subfractions (LDL, HDL, triglycerides) [ Time Frame: unknown ] [ Designated as safety issue: No ]
  • Economic outcomes (total cost of care, cost of diabetes-related care, presenteeism and absenteeism, medication adherence) [ Time Frame: unknown ] [ Designated as safety issue: No ]
  • Diabetes knowledge and empowerment (patient self-efficacy) [ Time Frame: unknown ] [ Designated as safety issue: No ]
  • Pharmacist time spent with program [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: November 2005
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Regularly-scheduled consulting session with pharmacists
    Regularly scheduled consulting session with pharmacist
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
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
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

No publications provided

Responsible Party: Oregon State University
ClinicalTrials.gov Identifier: NCT00254501     History of Changes
Other Study ID Numbers: OSU_COP_PP_0105, IRB Application 2979
Study First Received: November 14, 2005
Last Updated: October 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon State University:
diabetes

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

ClinicalTrials.gov processed this record on May 16, 2013