NCT00824499

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
375

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2004

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 16, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

January 16, 2009

Status Verified

January 1, 2009

Enrollment Period

3.8 years

First QC Date

January 15, 2009

Last Update Submit

January 15, 2009

Conditions

Outcome Measures

Primary Outcomes (1)

  • HBA1C

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

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (2)

DPA

EXPERIMENTAL

Regional complex intervention based on the Chronic Care Model

Other: Complex regional intervention

VR

NO INTERVENTION

Interventions

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

DPA

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All type 2 diabetes patients living in the defined intervention region
  • All caregivers involved in type 2 diabetes care in the defined intervention region

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Paul Van Royen, Prof. Ph.D. M.D.

    Universiteit Antwerpen

    STUDY DIRECTOR
  • Jan De Maeseneer, Prof. Ph.D. M.D.

    University Ghent

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 15, 2009

First Posted

January 16, 2009

Study Start

February 1, 2004

Primary Completion

December 1, 2007

Study Completion

June 1, 2009

Last Updated

January 16, 2009

Record last verified: 2009-01