title: Dementia care in the general practice setting: a cluster randomized trial on the effectiveness and cost impact of three management strategies.
abstract: OBJECTIVE
  To compare a complex nondrug intervention including actively approaching counseling and caregiver support groups with differing intensity against usual care with respect to time to institutionalization in patients with dementia.
  
  
  METHODS
  Within this three-armed cluster-randomized controlled trial, 390 community-dwelling patients aged 65 years or older with physician-diagnosed mild to moderate dementia and their caregivers were enrolled via 129 general practitioners in Middle Franconia, Germany. The intervention included general practitioners' training in dementia care and their recommendation of support groups and actively approaching caregiver counseling. Primary study end point was time to institutionalization over 2 years. In addition, long-term intervention effects were assessed over a time horizon of 4 years. Secondary end points included cognitive functioning, (instrumental) activities of daily living, burden of caregiving, and health-related quality of life after 2 years. Frailty models with strict intention-to-treat approach and mixed linear models were applied to account for cluster randomization. Health care costs were assessed from the societal perspective.
  
  
  RESULTS
  After 2 (4) years, 12% (24%) of the patients were institutionalized and another 21% (35%) died before institutionalization. No significant differences between study groups were observed with respect to time to institutionalization after 2 and 4 years (P 0.25 and 0.71, respectively). Secondary end points deteriorated, but differences were not significant between study groups. Almost 80% of the health care costs were due to informal care. Total annual costs amounted to more than €47,000 per patient and did not differ between study arms.
  
  
  CONCLUSIONS
  The intervention showed no effects on time to institutionalization and secondary outcomes.
authors.affiliation: Helmholtz Zentrum München, Neuherberg, Germany. petra.menn@helmholtz-muenchen.de
authors.forename: Petra
authors.initials: P
authors.lastname: Menn
authors.forename: Rolf
authors.initials: R
authors.lastname: Holle
authors.forename: Simone
authors.initials: S
authors.lastname: Kunz
authors.forename: Carolin
authors.initials: C
authors.lastname: Donath
authors.forename: Jörg
authors.initials: J
authors.lastname: Lauterberg
authors.forename: Reiner
authors.initials: R
authors.lastname: Leidl
authors.forename: Peter
authors.initials: P
authors.lastname: Marx
authors.forename: Hilmar
authors.initials: H
authors.lastname: Mehlig
authors.forename: Stephan
authors.initials: S
authors.lastname: Ruckdäschel
authors.forename: Horst Christian
authors.initials: HC
authors.lastname: Vollmar
authors.forename: Sonja
authors.initials: S
authors.lastname: Wunder
authors.forename: Elmar
authors.initials: E
authors.lastname: Gräßel
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D017028:Caregivers; D016000:Cluster Analysis; D057186:Comparative Effectiveness Research; D003704:Dementia / Q000451:nursing* / Q000503:physiopathology; D019468:Disease Management; D005260:Female; D058006:General Practice; D005858:Germany; D006801:Humans; D008297:Male; D008962:Models, Theoretical