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

Study Overview
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Brief Summary
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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
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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).

Official Title
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Development, Implementation and Evaluation of a Complex Regional Intervention for Type 2 Diabetes.

Conditions
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Diabetes Type 2

Intervention / Treatment
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* Other: Complex regional intervention


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DPA<br>Regional complex intervention based on the Chronic Care Model | Other: Complex regional intervention<br>* 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<br>|
| No Intervention: VR<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBA1C |  | Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Cholesterol |  | Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006 | 
| LDL-C |  | Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006 | 
| HDL-C |  | Longitudinal 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 creatinine |  | Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006 | 
| ophthalmist consults |  | Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006 | 
| Statine prescriptions |  | Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006 | 
| Influenza Vaccination Prescriptions |  | Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006 |