CClinicalTrials.gg
Status unknownNCT00824499DPAUpdated Jan 16, 2009

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

An interventional study of Complex regional intervention in Diabetes Type 2, sponsored by Universiteit Antwerpen. Status unknown. Per ClinicalTrials.gov, last updated 2009-01-16.

Sponsored by Universiteit Antwerpen · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Jan 2009), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
375
Sex
All
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Study 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.

Read the 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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Conditions studied

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In context

Diabetes Mellitus

10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's enrollment of 375 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Universiteit Antwerpen is the lead sponsor of 128 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • None
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Study design

Phase
Not applicable
Primary purpose
Health services research
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
375 participants (actual)

Study arms

  • Experimental
    DPA

    Regional complex intervention based on the Chronic Care Model

    Other: Complex regional intervention

  • No intervention
    VR

Interventions

  • OtherComplex 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

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What researchers measure

Primary outcomes

  1. HBA1C

    Time frame: Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006

Secondary outcomes

  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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Study locations

No study locations are listed for this record.

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References and documents

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. PubMed 25145469 ↗
  • 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. PubMed 20630062 ↗
  • 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. PubMed 19698185 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00824499
Lead sponsor
Universiteit Antwerpen
Collaborators
Belgian National Health Insurance Organisation (RIZIV), University Ghent
First posted
Jan 16, 2009
Start date
Feb 2004
Primary completion
Dec 2007
Completion
Jun 2009 (estimated)
Last update
Jan 16, 2009

Study contacts

Paul Van Royen, Prof. Ph.D. M.D.
study director · Universiteit Antwerpen
Jan De Maeseneer, Prof. Ph.D. M.D.
study director · University Ghent

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.

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