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

December 19, 2007 updated by: University Ghent

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).

Study Overview

Status

Completed

Conditions

Diabetes Mellitus

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

288

Phase

Not Applicable

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

Belgium
- - Ghent, Belgium, 9000
    - University Hospital Ghent

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

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 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: Treatment
Allocation: Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The difference between the study groups in the change of blood glucose and HbA1c Time Frame: baseline and after 6 months	baseline and after 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Knowledge about diabetes and treatment Time Frame: after 6 months	after 6 months
Therapy adherence
Body Mass Index Time Frame: after 6 months	after 6 months
Periods of severe hypoglycemia
GP visits, emergency room visits and hospitalisations
Work days lost
Frequency of eye and foot examination

Collaborators and Investigators

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

Sponsor

University Ghent

Investigators

Principal Investigator: Mimi Giri, MD, PhD, University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Website University Ghent

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

January 1, 2006

Study Completion

November 1, 2006

Study Registration Dates

First Submitted

January 13, 2006

First Submitted That Met QC Criteria