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Clinical Trials/NCT00824499
NCT00824499
Unknown
Not Applicable

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

Universiteit Antwerpen0 sites375 target enrollmentFebruary 2004
ConditionsDiabetes Type 2

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Type 2
Sponsor
Universiteit Antwerpen
Enrollment
375
Primary Endpoint
HBA1C
Last Updated
17 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
February 2004
End Date
June 2009
Last Updated
17 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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

  • Not provided

Outcomes

Primary Outcomes

HBA1C

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

Secondary Outcomes

  • 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)

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