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

NCT ID: NCT00824499

Last Updated: 2009-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

375 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2009-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

DPA

Regional complex intervention based on the Chronic Care Model

Group Type EXPERIMENTAL

Complex regional intervention

Intervention Type OTHER

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

VR

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Belgian National Health Insurance Organisation (RIZIV)

UNKNOWN

Sponsor Role collaborator

University Ghent

OTHER

Sponsor Role collaborator

Universiteit Antwerpen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Department of General Practice, University of Antwerp

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Paul Van Royen, Prof. Ph.D. M.D.

Role: STUDY_DIRECTOR

Universiteit Antwerpen

Jan De Maeseneer, Prof. Ph.D. M.D.

Role: STUDY_DIRECTOR

University Ghent

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 25145469 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20630062 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19698185 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A0456

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Patients With Type 2 Diabetes
NCT07245082 RECRUITING