Overview

This trial is active, not recruiting.

Condition diabetes type 2
Treatment complex regional intervention
Sponsor Universiteit Antwerpen
Collaborator Belgian National Health Insurance Organisation (RIZIV)
Start date February 2004
End date December 2007
Trial size 375 participants
Trial identifier NCT00824499, A0456

Summary

The purpose of this study is to determine whether regional implementation of shared care with respect to type 2 diabetes is feasible, effective and cost-effective.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(Experimental)
Regional complex intervention based on the Chronic Care Model
complex regional intervention
Components of the complex intervention: Introduction of a program coordinator Introduction of a self-management education program Bottom up development of a interdisciplinary care protocol Support program for the intiation of insulin therapy in primary care Regional audit
(No Intervention)

Primary Outcomes

Measure
HBA1C
time frame: Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006

Secondary Outcomes

Measure
Total Cholesterol
time frame: Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006
LDL-C
time frame: Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006
HDL-C
time frame: Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006
microalb.
time frame: Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006
blood creatinine
time frame: Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006
ophthalmist consults
time frame: Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006
Statine prescriptions
time frame: Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006
Influenza Vaccination Prescriptions
time frame: Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - All type 2 diabetes patients living in the defined intervention region - All caregivers involved in type 2 diabetes care in the defined intervention region Exclusion Criteria: - None

Additional Information

Official title Development, Implementation and Evaluation of a Complex Regional Intervention for Type 2 Diabetes.
Description Background Diabetes is an important chronic condition with significant associated morbidity and mortality, which can be reduced by effective care. An interdisciplinary approach, sharing responsibility and involvement and education of patients are of major importance in diabetes care. In Belgium a research project aimed at creating regional diabetes shared care was set up. Research questions - Is regional implementation of shared care feasible? - Does it increases quality of care (evidence based care) and patient satisfaction with care? - Does it have a positive effect on health status (emotional distress, overall quality of life, Hba1c)? Methods Controlled trial (July 2004 - June 2006) with a regional complex intervention comprising introduction of a care-manager and 2 community based diabetes educators, development and implementation of a shared care protocol (with a central role for the GP), regional feedback on the quality of diabetes care and patient education. Practitioners and patients participate on a voluntary basis. In the control region usual care continues. Biophysical, psychosocial and process outcomes were collected thru GP registration of patients records and self-administered patient questionnaires (PAID, QUOTE).
Trial information was received from ClinicalTrials.gov and was last updated in January 2009.
Information provided to ClinicalTrials.gov by Universiteit Antwerpen.