Study protocol

Effectiveness of the Austrian disease-management-programme for type 2 diabetes: study protocol of a cluster-randomized controlled trial

Andreas C Sönnichsen¹ , Andreas Rinnerberger^{* 1} , Maria G Url^{* 1} , Henrike Winkler^{* 1} , Peter Kowatsch^{* 2} , Gert Klima^{* 3} , Bernhard Fürthauer^{* 4} and Raimund Weitgasser^{* 2,5,6}

¹Institute of General Practice, Family Medicine and Preventive Medicine, Paracelsus Medical University, Strubergasse 21, 5020 Salzburg, Austria

²Workinggroup for Preventive Medicine, Salzburg (AVOS) Elisabethstrasse 2, 5020 Salzburg, Austria

³Styrian Public Health Insurance, Josef-Pongratz-Platz 1, 8011 Graz, Austria

⁴Austrian Association of General Practice (ÖGAM), Alser Strasse, 1090 Vienna, Austria

⁵Medical Department I, University Hospital, Paracelsus Medical University, Müllner Hauptstrasse 48, 5020 Salzburg, Austria

⁶Austrian Diabetes Association (ÖDG), Währingerstrasse 76/13, 1090 Vienna, Austria

author email corresponding author email* Contributed equally

Trials 2008, 9:38doi:10.1186/1745-6215-9-38

Published:	19 June 2008

Abstract

Background

Due to its rising prevalence type 2 diabetes plays an important role concerning population health in Austria and other western countries. In various studies deficiencies in the care of diabetic patients have been revealed. These deficiencies may be overcome by disease-management-programmes (DMPs), but international experience shows that the effectiveness of DMPs is inconsistent. In particular large programmes designed by state-affiliated public health insurances have not been evaluated in randomized controlled trials (RCTs). We are therefore conducting a large scale RCT of the Austrian DMP for type 2 diabetic patients in the province of Salzburg to evaluate the programme regarding its effects on metabolic control, guideline adherent care and the quality of life of diabetic patients.

Methods/Design

The study is open for participation to all GPs and internists in the province of Salzburg. Physicians are randomized before recruitment of patients with the districts of Salzburg as clusters of randomisation. A total of over 1200 patients with type 2 diabetes will then be recruited. In the intervention group the DMP is applied for one year. Controls receive usual care. Endpoints are a decrease in HbA1c in the intervention group > 0,5% compared to controls, a higher percentage of patients with required diagnostic measures according to guidelines, improved cardiovascular risk profile and higher quality of life scores within one year.

Current status of the study

98 Physicians agreed to participate in the study. 96 of them recruited 1494 patients, 654 in the intervention and 840 in the control group.

Trail Registration

This trial has been registered with Current Controlled Trials Ltd. (ISRCTN27414162).