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Pharmaceutical Care for Diabetes Type 2 Patients: a Randomised Controlled Trial

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ClinicalTrials.gov Identifier: NCT00277732
Recruitment Status : Completed
First Posted : January 16, 2006
Last Update Posted : December 28, 2007
Sponsor:
Information provided by:
University Ghent

Brief Summary:
The objective of this study is to evaluate the therapeutic effectiveness and cost-effectivity of pharmaceutical care for diabetes type 2 patients. Patients will be randomly allocated to the control group ( = no input from pharmacist) or intervention group ( = with pharmaceutical care at baseline and follow-up visits over 6 months).

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Procedure: Pharmaceutical care at baseline and follow-up visits over 6 months Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmaceutical Care for Diabetes Type 2 Patients: a Randomised Controlled Trial
Study Start Date : January 2006
Study Completion Date : November 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. The difference between the study groups in the change of blood glucose and HbA1c [ Time Frame: baseline and after 6 months ]

Secondary Outcome Measures :
  1. Knowledge about diabetes and treatment [ Time Frame: after 6 months ]
  2. Therapy adherence
  3. Body Mass Index [ Time Frame: after 6 months ]
  4. Periods of severe hypoglycemia
  5. GP visits, emergency room visits and hospitalisations
  6. Work days lost
  7. Frequency of eye and foot examination


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 45-75 years
  • Body Mass Index >= 25
  • Diabetes treatment for at least 12 months
  • Regular visitors of the participating community pharmacy

Exclusion Criteria:

  • Patients taking only insulin (no oral antidiabetic drugs)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00277732


Locations
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Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Ghent
Investigators
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Principal Investigator: Mimi Giri, MD, PhD University Hospital, Ghent

Additional Information:
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ClinicalTrials.gov Identifier: NCT00277732     History of Changes
Other Study ID Numbers: 2005/340
First Posted: January 16, 2006    Key Record Dates
Last Update Posted: December 28, 2007
Last Verified: December 2007

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