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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00277732
Other study ID # 2005/340
Secondary ID
Status Completed
Phase N/A
First received January 13, 2006
Last updated December 19, 2007
Start date January 2006
Est. completion date November 2006

Study information

Verified date December 2007
Source University Ghent
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 288
Est. completion date November 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 45 Years to 75 Years
Eligibility 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Pharmaceutical care at baseline and follow-up visits over 6 months


Locations

Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (1)

Lead Sponsor Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary The difference between the study groups in the change of blood glucose and HbA1c baseline and after 6 months
Secondary Knowledge about diabetes and treatment after 6 months
Secondary Therapy adherence
Secondary Body Mass Index after 6 months
Secondary Periods of severe hypoglycemia
Secondary GP visits, emergency room visits and hospitalisations
Secondary Work days lost
Secondary Frequency of eye and foot examination
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