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Open Access Study protocol

Blood glucose testing and primary prevention of diabetes mellitus type 2 - evaluation of the effect of evidence based patient information

Jutta Genz1*, Burkhard Haastert2, Gabriele Meyer3, Anke Steckelberg4, Hardy Müller5, Frank Verheyen5, Dennis Cole5, Wolfgang Rathmann1, Bettina Nowotny6, Michael Roden6, Guido Giani1, Andreas Mielck7, Christian Ohmann8 and Andrea Icks1

Author Affiliations

1 German Diabetes-Centre, Leibniz Institute at Heinrich Heine University Düsseldorf, Institute of Biometrics and Epidemiology, Auf'm Hennekamp 65, 40225 Düsseldorf, Germany

2 Medistatistica, Lambertusweg 1b, 58809 Neuenrade, Germany

3 Witten/Herdecke University, Faculty of Medicine, Institute of Nursing Sciences, Stockumer Straße 12, 58453 Witten, Germany

4 University of Hamburg, MIN Faculty, Health Sciences, Hamburg, Germany

5 WINEG - Scientific Institute for Benefit and Efficiency in Health Care, Habichtstraße 30, 22305 Hamburg, Germany

6 German Diabetes-Centre, Leibniz Institute at Heinrich Heine University Düsseldorf, Institute of Clinical Diabetology, Auf'm Hennekamp 65, 40225 Düsseldorf, Germany

7 Helmholtz Zentrum München - German Research Center for Environmental Health, Institute of Health Economics and Health Care Management, P.O. Box 1129, 85758 Neuherberg, Germany

8 Heinrich-Heine-University Düsseldorf, Coordination Centre for Clinical Trials (KKS), Moorenstr. 5, 40225 Düsseldorf, Germany

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BMC Public Health 2010, 10:15  doi:10.1186/1471-2458-10-15

Published: 14 January 2010

Abstract

Background

Evidence-based patient information (EBPI) has been recognised as important tool for informed choice in particular in the matter of preventive options. An objective, on the best scientific evidence-based consumer information about subthreshold elevated blood glucose levels (impaired fasting glucose and impaired glucose tolerance) and primary prevention of diabetes, is not available yet. Thus we developed a web-based EBPI and aim to evaluate its effects on informed decision making in people 50 years or older.

Methods/Design

We conduct a web-based randomised-controlled trial to evaluate the effect of information about elevated blood glucose levels and diabetes primary prevention on five specific outcomes: (i) knowledge of elevated blood glucose level-related issues (primary outcome); (ii) attitudes to a metabolic testing; (iii) intention to undergo a metabolic testing; (iv) decision conflict; (v) satisfaction with the information. The intervention group receives a specially developed EBPI about subthreshold elevated blood glucose levels and diabetes primary prevention, the control group information about this topic, available in the internet.

The study population consists of people between 50 and 69 years of age without known diabetes. Participants will be recruited via the internet page of the cooperating health insurance company, Techniker Krankenkasse (TK), and the internet page of the German Diabetes Centre. Outcomes will be measured through online questionnaires. We expect better informed participants in the intervention group.

Discussion

The design of this study may be a prototype for other web-based prevention information and their evaluation.

Trial registration

Current Controlled Trial: ISRCTN22060616.