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

Diabetes Type 2 Clinical Trial

— DPA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00824499
• Other study ID #: A0456
• Status: Active, not recruiting
• Phase: N/A
• First received: January 15, 2009
• Last updated: January 15, 2009
• Start date: February 2004
• Est. completion date: June 2009

Study information

• Verified date: January 2009
• Source: Universiteit Antwerpen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 375
• Est. completion date: June 2009
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetes Type 2

Intervention

Other:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Universiteit Antwerpen	Belgian National Health Insurance Organisation (RIZIV), University Ghent

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HBA1C		Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006	No
Secondary	Total Cholesterol		Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006	No
Secondary	LDL-C		Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006	No
Secondary	HDL-C		Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006	No
Secondary	microalb.		Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006	No
Secondary	blood creatinine		Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006	No
Secondary	ophthalmist consults		Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006	No
Secondary	Statine prescriptions		Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006	No
Secondary	Influenza Vaccination Prescriptions		Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006	No