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

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

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes Type 2
• Intervention / Treatment: Other: Complex regional intervention

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).

• Study Type: Interventional
• Enrollment (Actual): 375
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: DPA; Regional complex intervention based on the Chronic Care Model	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
NO_INTERVENTION: VR

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Universiteit Antwerpen
• Collaborators: University Ghent; Belgian National Health Insurance Organisation (RIZIV)
• Investigators: Study Director: Paul Van Royen, Prof. Ph.D. M.D., Universiteit Antwerpen; Study Director: Jan De Maeseneer, Prof. Ph.D. M.D., University of Ghent

Publications and helpful links

General Publications

• Sunaert P, Willems S, Feyen L, Bastiaens H, De Maeseneer J, Jenkins L, Nobels F, Samyn E, Vandekerckhove M, Wens J, De Sutter A. Engaging GPs in insulin therapy initiation: a qualitative study evaluating a support program in the Belgian context. BMC Fam Pract. 2014 Aug 21;15:144. doi: 10.1186/1471-2296-15-144.
• Sunaert P, Bastiaens H, Nobels F, Feyen L, Verbeke G, Vermeire E, De Maeseneer J, Willems S, De Sutter A. Effectiveness of the introduction of a Chronic Care Model-based program for type 2 diabetes in Belgium. BMC Health Serv Res. 2010 Jul 14;10:207. doi: 10.1186/1472-6963-10-207.
• Sunaert P, Bastiaens H, Feyen L, Snauwaert B, Nobels F, Wens J, Vermeire E, Van Royen P, De Maeseneer J, De Sutter A, Willems S. Implementation of a program for type 2 diabetes based on the Chronic Care Model in a hospital-centered health care system: "the Belgian experience". BMC Health Serv Res. 2009 Aug 23;9:152. doi: 10.1186/1472-6963-9-152.

Study record dates

Study Major Dates

• Study Start: February 1, 2004
• Primary Completion (ACTUAL): December 1, 2007
• Study Completion (ANTICIPATED): June 1, 2009

Study Registration Dates

• First Submitted: January 15, 2009
• First Submitted That Met QC Criteria: January 15, 2009
• First Posted (ESTIMATE): January 16, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): January 16, 2009
• Last Update Submitted That Met QC Criteria: January 15, 2009
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: A0456