Pharmacists Management of Diabetes

March 24, 2009 updated by: Advantage Health Physician Network

Pharmacist Management of Diabetes Mellitus: A Randomized Controlled Trial.

The hypothesis is that patients with poorly controlled diabetes would have greater improvement in their blood sugar control when managed by a clinical pharmacist than when managed with usual medical care. Patients with poor control are randomized to pharmacist management or to usual medical care for one year.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Advantage Health Physican Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 years or older
  • A1c greater than or equal to 9.0

Exclusion Criteria:

  • Not expected to live for the duration of the study
  • Managed by an endocrinologist
  • Unwillingness to participate and attend pharmacist visits

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pharmacist Management
In this arm the Pharmacist managed the Diabetes in collaboration with the primary care physician
Other: Pharmacist Management
Pharmacist Managed the patient's diabetes in collaboration with their primary care physician
Active Comparator: Usual Care
The patient was managed by the primary care physician
Other: Usual care
Patient was managed by their primary care physician as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hgb A1c change
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
HgbA1c change based on ethnicity
Time Frame: one year
one year
percent of patients with a 1 point or greater decrease in A1c
Time Frame: one year
one year
Percent of patients with a 1 point decrease in A1c by ethnicity
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advantage Health Physician Network

Collaborators

Doran Foundation
Michigan Pharmacist Foundation
Priority Health
Western Michigan Society of Health System Pharmacists

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

March 23, 2009

First Submitted That Met QC Criteria

March 24, 2009

First Posted (Estimate)

March 25, 2009

Study Record Updates

Last Update Posted (Estimate)

March 25, 2009

Last Update Submitted That Met QC Criteria

March 24, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PharmacistDiabetesJameson

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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