Pharmacists Management of Diabetes

This study has been completed.
Sponsor:
Collaborators:
Doran Foundation
Michigan Pharmacist Foundation
Priority Health
Western Michigan Society of Health System Pharmacists
Information provided by:
Advantage Health Physician Network
ClinicalTrials.gov Identifier:
NCT00869076
First received: March 23, 2009
Last updated: March 24, 2009
Last verified: March 2009
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus
Other: Pharmacist Management
Other: Usual care
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Pharmacist Management of Diabetes Mellitus: A Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Advantage Health Physician Network:

Primary Outcome Measures:
  • Hgb A1c change [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HgbA1c change based on ethnicity [ Time Frame: one year ] [ Designated as safety issue: No ]
  • percent of patients with a 1 point or greater decrease in A1c [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Percent of patients with a 1 point decrease in A1c by ethnicity [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 102
Study Start Date: May 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00869076

Locations
United States, Michigan
Advantage Health Physican Network
Grand Rapids, Michigan, United States, 49503
Sponsors and Collaborators
Advantage Health Physician Network
Doran Foundation
Michigan Pharmacist Foundation
Priority Health
Western Michigan Society of Health System Pharmacists
  More Information

No publications provided

Responsible Party: John Jameson, PharmD., Ferris State University
ClinicalTrials.gov Identifier: NCT00869076     History of Changes
Other Study ID Numbers: PharmacistDiabetesJameson
Study First Received: March 23, 2009
Last Updated: March 24, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Advantage Health Physician Network:
Diabetes Mellitus
Pharmacist

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 28, 2014