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Development, Implementation and Evaluation of a Complex Regional Intervention for Type 2 Diabetes: Diabetes Project Aalst

Not Applicable
Conditions
Diabetes Type 2
Interventions
Other: Complex regional intervention
Registration Number
NCT00824499
Lead Sponsor
Universiteit Antwerpen
Brief 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.

Detailed 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).

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
375
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
DPAComplex regional interventionRegional complex intervention based on the Chronic Care Model
Primary Outcome Measures
NameTimeMethod
HBA1CLongitudinal analysis on measurements from 01/01/2004 until 31/12/2006
Secondary Outcome Measures
NameTimeMethod
Total CholesterolLongitudinal analysis on measurements from 01/01/2004 until 31/12/2006
LDL-CLongitudinal analysis on measurements from 01/01/2004 until 31/12/2006
HDL-CLongitudinal analysis on measurements from 01/01/2004 until 31/12/2006
microalb.Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006
blood creatinineLongitudinal analysis on measurements from 01/01/2004 until 31/12/2006
ophthalmist consultsLongitudinal analysis on measurements from 01/01/2004 until 31/12/2006
Statine prescriptionsLongitudinal analysis on measurements from 01/01/2004 until 31/12/2006
Influenza Vaccination PrescriptionsLongitudinal analysis on measurements from 01/01/2004 until 31/12/2006
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