NCT00277732

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
288

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Jan 2006

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 16, 2006

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

December 28, 2007

Status Verified

December 1, 2007

First QC Date

January 13, 2006

Last Update Submit

December 19, 2007

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • The difference between the study groups in the change of blood glucose and HbA1c

    baseline and after 6 months

Secondary Outcomes (7)

  • Knowledge about diabetes and treatment

    after 6 months

  • Therapy adherence

  • Body Mass Index

    after 6 months

  • Periods of severe hypoglycemia

  • GP visits, emergency room visits and hospitalisations

  • +2 more secondary outcomes

Interventions

Pharmaceutical care at baseline and follow-up visits over 6 monthsPROCEDURE

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients taking only insulin (no oral antidiabetic drugs)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Mimi Giri, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 13, 2006

First Posted

January 16, 2006

Study Start

January 1, 2006

Study Completion

November 1, 2006

Last Updated

December 28, 2007

Record last verified: 2007-12

Locations

BE(1)