Back to resultsPharmaceutical Care for Diabetes Type 2 Patients: a Randomised Controlled Trial
Primary Purpose
Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Pharmaceutical care at baseline and follow-up visits over 6 months
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus
Eligibility 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)
Sites / Locations
- University Hospital Ghent
Outcomes
Primary Outcome Measures
The difference between the study groups in the change of blood glucose and HbA1c
Secondary Outcome Measures
Knowledge about diabetes and treatment
Therapy adherence
Body Mass Index
Periods of severe hypoglycemia
GP visits, emergency room visits and hospitalisations
Work days lost
Frequency of eye and foot examination
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00277732
Brief Title
Pharmaceutical Care for Diabetes Type 2 Patients: a Randomised Controlled Trial
Official Title
Pharmaceutical Care for Diabetes Type 2 Patients: a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Ghent
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
288 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Pharmaceutical care at baseline and follow-up visits over 6 months
Primary Outcome Measure Information:
Title
The difference between the study groups in the change of blood glucose and HbA1c
Time Frame
baseline and after 6 months
Secondary Outcome Measure Information:
Title
Knowledge about diabetes and treatment
Time Frame
after 6 months
Title
Therapy adherence
Title
Body Mass Index
Time Frame
after 6 months
Title
Periods of severe hypoglycemia
Title
GP visits, emergency room visits and hospitalisations
Title
Work days lost
Title
Frequency of eye and foot examination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mimi Giri, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.ugent.be
Description
Website University Ghent
Learn more about this trial
Pharmaceutical Care for Diabetes Type 2 Patients: a Randomised Controlled Trial
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