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BMC Public Health
Published in: BMC Public Health 1/2005

Open Access 01-12-2005 | Study protocol

ELSID-Diabetes study-evaluation of a large scale implementation of disease management programmes for patients with type 2 diabetes. Rationale, design and conduct – a study protocol [ISRCTN08471887]

Authors: Stefanie Joos, Thomas Rosemann, Marc Heiderhoff, Michel Wensing, Sabine Ludt, Jochen Gensichen, Petra Kaufmann-Kolle, Joachim Szecsenyi

Published in: BMC Public Health | Issue 1/2005

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Abstract

Background

Diabetes model projects in different regions of Germany including interventions such as quality circles, patient education and documentation of medical findings have shown improvements of HbA1c levels, blood pressure and occurrence of hypoglycaemia in before-after studies (without control group). In 2002 the German Ministry of Health defined legal regulations for the introduction of nationwide disease management programs (DMP) to improve the quality of care in chronically ill patients. In April 2003 the first DMP for patients with type 2 diabetes was accredited. The evaluation of the DMP is essential and has been made obligatory in Germany by the Fifth Book of Social Code. The aim of the study is to assess the effectiveness of DMP by example of type 2 diabetes in the primary care setting of two German federal states (Rheinland-Pfalz and Sachsen-Anhalt).

Methods/Design

The study is three-armed: a prospective cluster-randomized comparison of two interventions (DMP 1 and DMP 2) against routine care without DMP as control group. In the DMP group 1 the patients are treated according to the current situation within the German-Diabetes-DMP. The DMP group 2 represents diabetic care within ideally implemented DMP providing additional interventions (e.g. quality circles, outreach visits). According to a sample size calculation a sample size of 200 GPs (each GP including 20 patients) will be required for the comparison of DMP 1 and DMP 2 considering possible drop-outs. For the comparison with routine care 4000 patients identified by diabetic tracer medication and age (> 50 years) will be analyzed.

Discussion

This study will evaluate the effectiveness of the German Diabetes-DMP compared to a Diabetes-DMP providing additional interventions and routine care in the primary care setting of two different German federal states.
Appendix
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Metadata
Title
ELSID-Diabetes study-evaluation of a large scale implementation of disease management programmes for patients with type 2 diabetes. Rationale, design and conduct – a study protocol [ISRCTN08471887]
Authors
Stefanie Joos
Thomas Rosemann
Marc Heiderhoff
Michel Wensing
Sabine Ludt
Jochen Gensichen
Petra Kaufmann-Kolle
Joachim Szecsenyi
Publication date
01-12-2005
Publisher
BioMed Central
Published in
BMC Public Health / Issue 1/2005
Electronic ISSN: 1471-2458
DOI
https://doi.org/10.1186/1471-2458-5-99

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