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


Holle, Rolf, Grässel, Elmar, Ruckdäschel, Stefan, Wunder, Sonja, Mehlig, Hilmar, Marx, Peter, Pirk, Olaf, Butzlaff, Martin, Kunz, Simone, Lauterberg, Jörg


BMC Health Services Research, Volume: 9, Pages.: 91-91

Year of Publication



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.;

Bibtex Citation

@article{Holle_2009, doi = {10.1186/1472-6963-9-91}, url = {}, year = 2009, month = {jun}, publisher = {Springer Nature}, volume = {9}, number = {1}, author = {Rolf Holle and Elmar Grä{ss}el and Stefan Ruckdäschel and Sonja Wunder and Hilmar Mehlig and Peter Marx and Olaf Pirk and Martin Butzlaff and Simone Kunz and Jörg Lauterberg}, title = {Dementia care initiative in primary practice {textendash} study protocol of a cluster randomized trial on dementia management in a general practice setting}, journal = {{BMC} Health Services Research} }


admission, aged, aged, 80 and over, care, cluster analysis, counseling, counselling, dementia, germany, health services research, home, humans, middle aged, organization administration, outcome and process assessment health care, primary health care, psychology, questionnaires, research design, social support, therapy, time

Countries of Study


Types of Dementia

Dementia (general / unspecified)

Types of Study

Cluster RCT, Cost and service use study

Type of Outcomes

ADLs/IADLs, Carer Burden (instruments measuring burden), Cognition, Service use or cost reductions (incl. hospital use reduction, care home admission delay)



Type of Interventions

Intervention for Carers

Carer Focussed Interventions

Information and Advice, Other, Training programmes / workshops including behavioural training