Clinical trial NCT00824499: Development, Implementation and Evaluation of a Complex Regional Intervention for Type 2 Diabetes: Diabetes Project Aalst
Official title: Development, Implementation and Evaluation of a Complex Regional Intervention for Type 2 Diabetes.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Type 2
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
Collaborators: name: Belgian National Health Insurance Organisation (RIZIV)
name: University Ghent
First posted: 2009-01-16
Enrollment: 375
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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

Primary outcomes:
measure: HBA1C
timeFrame: Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006
Secondary outcomes:
measure: Total Cholesterol
timeFrame: Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006
measure: LDL-C
timeFrame: Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006
measure: HDL-C
timeFrame: Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006
measure: microalb.
timeFrame: Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006
measure: blood creatinine
timeFrame: Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006
measure: ophthalmist consults
timeFrame: Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006
measure: Statine prescriptions
timeFrame: Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006
measure: Influenza Vaccination Prescriptions
timeFrame: Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006
Other outcomes:
Locations:
Study officials:
affiliation: Universiteit Antwerpen
name: Paul Van Royen, Prof. Ph.D. M.D.
role: STUDY_DIRECTOR
affiliation: University Ghent
name: Jan De Maeseneer, Prof. Ph.D. M.D.
role: STUDY_DIRECTOR
References:
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.
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.
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.