title: Dementia care initiative in primary practice: study protocol of a cluster randomized trial on dementia management in a general practice setting.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ISRCTN68329593.
authors.affiliation: Institute of Health Economics and Health Care Management, Helmholtz Zentrum, München, Germany. holle@helmholtz-muenchen.de
authors.forename: Rolf
authors.initials: R
authors.lastname: Holle
authors.forename: Elmar
authors.initials: E
authors.lastname: Grässel
authors.forename: Stefan
authors.initials: S
authors.lastname: Ruckdäschel
authors.forename: Sonja
authors.initials: S
authors.lastname: Wunder
authors.forename: Hilmar
authors.initials: H
authors.lastname: Mehlig
authors.forename: Peter
authors.initials: P
authors.lastname: Marx
authors.forename: Olaf
authors.initials: O
authors.lastname: Pirk
authors.forename: Martin
authors.initials: M
authors.lastname: Butzlaff
authors.forename: Simone
authors.initials: S
authors.lastname: Kunz
authors.forename: Jörg
authors.initials: J
authors.lastname: Lauterberg
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D016000:Cluster Analysis; D003376:Counseling; D003704:Dementia / Q000523:psychology / Q000628:therapy*; D005858:Germany; D006302:Health Services Research; D006801:Humans; D008875:Middle Aged; D010043:Outcome and Process Assessment, Health Care; D011320:Primary Health Care / Q000458:organization & administration*; D012107:Research Design; D012944:Social Support; D011795:Surveys and Questionnaires