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Open Access Study protocol

Dementia care initiative in primary practice – study protocol of a cluster randomized trial on dementia management in a general practice setting

Rolf Holle12*, Elmar Gräßel3, Stefan Ruckdäschel4, Sonja Wunder5, Hilmar Mehlig6, Peter Marx7, Olaf Pirk8, Martin Butzlaff9, Simone Kunz12 and Jörg Lauterberg10

Author Affiliations

1 Institute of Health Economics and Health Care Management, Helmholtz Zentrum, München, Germany

2 German Research Center for Environmental Health, Neuherberg, Germany

3 Department of Psychiatry and Psychotherapy, Medical Psychology and Medical Sociology, University Hospital Erlangen, Erlangen, Germany

4 HealthEcon AG, Basel, Switzerland

5 AOK Bavaria, Nürnberg, Germany

6 Eisai GmbH, Frankfurt, Germany

7 Pfizer Germany GmbH, Berlin, Germany

8 Health Economics and Outcomes Research, IMS Health GmbH & Co. OHG, Nürnberg, Germany

9 Competence Center for General Practice and Outpatients' Health Care, Witten/Herdecke University, Witten, Germany

10 Federal Association of the AOK, Berlin, Germany, and Institute for Patient Safety, University of Bonn, Bonn, Germany

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BMC Health Services Research 2009, 9:91  doi:10.1186/1472-6963-9-91

Published: 6 June 2009

Abstract

Background

Current guidelines for dementia care recommend the combination of drug therapy with non-pharmaceutical measures like counselling and social support. However, the scientific evidence concerning non-pharmaceutical interventions for dementia patients and their informal caregivers remains inconclusive. Targets of modern comprehensive dementia care are to enable patients to live at home as long and as independent as possible and to reduce the burden of caregivers. The objective of the study is to compare a complex intervention including caregiver support groups and counselling against usual care in terms of time to nursing home placement. In this paper the study protocol is described.

Methods/Design

The IDA (Initiative Demenzversorgung in der Allgemeinmedizin) project is designed as a three armed cluster-randomized trial where dementia patients and their informal caregivers are recruited by general practitioners. Patients in the study region of Middle Franconia, Germany, are included if they have mild or moderate dementia, are at least 65 years old, and are members of the German AOK (Allgemeine Ortskrankenkasse) sickness fund. In the control group patients receive regular treatment, whereas in the two intervention groups general practitioners participate in a training course in evidence based dementia treatment, recommend support groups and offer counseling to the family caregivers either beginning at baseline or after the 1-year follow-up. The study recruitment and follow-up took place from July 2005 to January 2009. 303 general practitioners were randomized of which 129 recruited a total of 390 patients. Time to nursing home admission within the two year intervention and follow-up period is the primary endpoint. Secondary endpoints are cognitive status, activities of daily living, burden of care giving as well as healthcare costs. For an economic analysis from the societal perspective, data are collected from caregivers as well as by the use of routine data from statutory health insurance and long-term care insurance.

Discussion

From a public health perspective, the IDA trial is expected to lead to evidence based results on the community effectiveness of non-pharmaceutical support measures for dementia patients and their caregivers in the primary care sector. For health policy makers it is necessary to make their decisions about financing new services based on strong knowledge about the acceptance of measures in the population and their cost-effectiveness.

Trial registration

ISRCTN68329593