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

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ClinicalTrials.gov Identifier: NCT00824499
Recruitment Status : Unknown
Verified January 2009 by Universiteit Antwerpen.
Recruitment status was:  Active, not recruiting
First Posted : January 16, 2009
Last Update Posted : January 16, 2009
Sponsor:
Collaborators:
Belgian National Health Insurance Organisation (RIZIV)
University Ghent
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Diabetes Type 2 Other: Complex regional intervention Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 375 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Development, Implementation and Evaluation of a Complex Regional Intervention for Type 2 Diabetes.
Study Start Date : February 2004
Actual Primary Completion Date : December 2007
Estimated Study Completion Date : June 2009

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. HBA1C [ Time Frame: Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006 ]

Secondary Outcome Measures :
  1. Total Cholesterol [ Time Frame: Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006 ]
  2. LDL-C [ Time Frame: Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006 ]
  3. HDL-C [ Time Frame: Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006 ]
  4. microalb. [ Time Frame: Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006 ]
  5. blood creatinine [ Time Frame: Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006 ]
  6. ophthalmist consults [ Time Frame: Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006 ]
  7. Statine prescriptions [ Time Frame: Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006 ]
  8. Influenza Vaccination Prescriptions [ Time Frame: Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00824499


Sponsors and Collaborators
Universiteit Antwerpen
Belgian National Health Insurance Organisation (RIZIV)
University Ghent
Investigators
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof.dr. Paul Van Royen, Department of General Practice, University of Antwerp
ClinicalTrials.gov Identifier: NCT00824499    
Other Study ID Numbers: A0456
First Posted: January 16, 2009    Key Record Dates
Last Update Posted: January 16, 2009
Last Verified: January 2009
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases