title: Effectiveness of a 6-year multidomain vascular care intervention to prevent dementia (preDIVA): a cluster-randomised controlled trial.
abstract: BACKGROUND
  Cardiovascular risk factors are associated with an increased risk of dementia. We assessed whether a multidomain intervention targeting these factors can prevent dementia in a population of community-dwelling older people.
  
  
  METHODS
  In this open-label, cluster-randomised controlled trial, we recruited individuals aged 70-78 years through participating general practices in the Netherlands. General practices within each health-care centre were randomly assigned (1:1), via a computer-generated randomisation sequence, to either a 6-year nurse-led, multidomain cardiovascular intervention or control (usual care). The primary outcomes were cumulative incidence of dementia and disability score (Academic Medical Center Linear Disability Score [ALDS]) at 6 years of follow-up. The main secondary outcomes were incident cardiovascular disease and mortality. Outcome assessors were masked to group assignment. Analyses included all participants with available outcome data. This trial is registered with ISRCTN, number ISRCTN29711771.
  
  
  RESULTS
  Between June 7, 2006, and March 12, 2009, 116 general practices (3526 participants) within 26 health-care centres were recruited and randomly assigned: 63 (1890 participants) were assigned to the intervention group and 53 (1636 participants) to the control group. Primary outcome data were obtained for 3454 (98%) participants; median follow-up was 6·7 years (21 341 person-years). Dementia developed in 121 (7%) of 1853 participants in the intervention group and in 112 (7%) of 1601 participants in the control group (hazard ratio [HR] 0·92, 95% CI 0·71-1·19; p=0·54). Mean ALDS scores measured during follow-up did not differ between groups (85·7 [SD 6·8] in the intervention group and 85·7 [7·1] in the control group; adjusted mean difference -0·02, 95% CI -0·38 to 0·42; p=0·93). 309 (16%) of 1885 participants died in the intervention group, compared with 269 (16%) of 1634 participants in the control group (HR 0·98, 95% CI 0·80-1·18; p=0·81). Incident cardiovascular disease did not differ between groups (273 [19%] of 1469 participants in the intervention group and 228 [17%] of 1307 participants in the control group; HR 1·06, 95% CI 0·86-1·31; p=0·57).
  
  
  CONCLUSIONS
  A nurse-led, multidomain intervention did not result in a reduced incidence of all-cause dementia in an unselected population of older people. This absence of effect might have been caused by modest baseline cardiovascular risks and high standards of usual care. Future studies should assess the efficacy of such interventions in selected populations.
  
  
  BACKGROUND
  Dutch Ministry of Health, Welfare and Sport; Dutch Innovation Fund of Collaborative Health Insurances; and Netherlands Organisation for Health Research and Development.
authors.affiliation: Department of General Practice, Academic Medical Centre, Amsterdam, Netherlands.
authors.forename: Eric P
authors.initials: EP
authors.lastname: Moll van Charante
authors.affiliation: Department of Neurology, Academic Medical Centre, Amsterdam, Netherlands; Department of Neurology, Radboud University Medical Centre, Nijmegen, Netherlands.
authors.forename: Edo
authors.initials: E
authors.lastname: Richard
authors.affiliation: Department of Neurology, Academic Medical Centre, Amsterdam, Netherlands.
authors.forename: Lisa S
authors.initials: LS
authors.lastname: Eurelings
authors.affiliation: Department of Neurology, Academic Medical Centre, Amsterdam, Netherlands.
authors.forename: Jan-Willem
authors.initials: JW
authors.lastname: van Dalen
authors.affiliation: Department of General Practice, Academic Medical Centre, Amsterdam, Netherlands.
authors.forename: Suzanne A
authors.initials: SA
authors.lastname: Ligthart
authors.affiliation: Department of General Practice, Academic Medical Centre, Amsterdam, Netherlands.
authors.forename: Emma F
authors.initials: EF
authors.lastname: van Bussel
authors.affiliation: Department of Neurology, Academic Medical Centre, Amsterdam, Netherlands.
authors.forename: Marieke P
authors.initials: MP
authors.lastname: Hoevenaar-Blom
authors.affiliation: Department of Neurology, Academic Medical Centre, Amsterdam, Netherlands.
authors.forename: Marinus
authors.initials: M
authors.lastname: Vermeulen
authors.affiliation: Department of Neurology, Academic Medical Centre, Amsterdam, Netherlands. Electronic address: w.a.vangool@amc.uva.nl.
authors.forename: Willem A
authors.initials: WA
authors.lastname: van Gool
mesh_terms: D000368:Aged; D002318:Cardiovascular Diseases / Q000150:complications* / Q000628:therapy*; D015986:Confounding Factors, Epidemiologic; D003704:Dementia / Q000453:epidemiology / Q000517:prevention & control; D015140:Dementia, Vascular / Q000453:epidemiology* / Q000209:etiology / Q000517:prevention & control*; D005260:Female; D005500:Follow-Up Studies; D058006:General Practice; D006801:Humans; D015994:Incidence; D057187:Independent Living; D053208:Kaplan-Meier Estimate; D008297:Male; D009426:Netherlands / Q000453:epidemiology; D024802:Nurse's Role; D016017:Odds Ratio; D012107:Research Design; D012307:Risk Factors; D016896:Treatment Outcome