Development, Implementation and Evaluation of a Complex Regional Intervention for Type 2 Diabetes: Diabetes Project Aalst (DPA)
Primary Purpose
Diabetes Type 2
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Complex regional intervention
Sponsored by
About this trial
This is an interventional health services research trial for Diabetes Type 2
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
DPA
VR
Arm Description
Regional complex intervention based on the Chronic Care Model
Outcomes
Primary Outcome Measures
HBA1C
Secondary Outcome Measures
Total Cholesterol
LDL-C
HDL-C
microalb.
blood creatinine
ophthalmist consults
Statine prescriptions
Influenza Vaccination Prescriptions
Full Information
NCT ID
NCT00824499
First Posted
January 15, 2009
Last Updated
January 15, 2009
Sponsor
Universiteit Antwerpen
Collaborators
Belgian National Health Insurance Organisation (RIZIV), University Ghent
1. Study Identification
Unique Protocol Identification Number
NCT00824499
Brief Title
Development, Implementation and Evaluation of a Complex Regional Intervention for Type 2 Diabetes: Diabetes Project Aalst
Acronym
DPA
Official Title
Development, Implementation and Evaluation of a Complex Regional Intervention for Type 2 Diabetes.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
February 2004 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
June 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Universiteit Antwerpen
Collaborators
Belgian National Health Insurance Organisation (RIZIV), University Ghent
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Type 2
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
375 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DPA
Arm Type
Experimental
Arm Description
Regional complex intervention based on the Chronic Care Model
Arm Title
VR
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Complex regional intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
HBA1C
Time Frame
Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006
Secondary Outcome Measure Information:
Title
Total Cholesterol
Time Frame
Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006
Title
LDL-C
Time Frame
Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006
Title
HDL-C
Time Frame
Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006
Title
microalb.
Time Frame
Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006
Title
blood creatinine
Time Frame
Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006
Title
ophthalmist consults
Time Frame
Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006
Title
Statine prescriptions
Time Frame
Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006
Title
Influenza Vaccination Prescriptions
Time Frame
Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Van Royen, Prof. Ph.D. M.D.
Organizational Affiliation
Universiteit Antwerpen
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jan De Maeseneer, Prof. Ph.D. M.D.
Organizational Affiliation
University of Ghent
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
25145469
Citation
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.
Results Reference
derived
PubMed Identifier
20630062
Citation
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.
Results Reference
derived
PubMed Identifier
19698185
Citation
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.
Results Reference
derived
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Development, Implementation and Evaluation of a Complex Regional Intervention for Type 2 Diabetes: Diabetes Project Aalst
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