title: A feasibility study and pilot randomised trial of a tailored prevention program to reduce falls in older people with mild dementia.
abstract: BACKGROUND
  People with dementia have a disproportionately high rate of falls and fractures and poorer outcomes, yet there is currently no evidence to guide falls prevention in this population.
  
  
  METHODS
  A randomised trial design was used to test feasibility of study components and acceptability of a home hazard reduction and balance and strength exercise fall prevention program. The program was tailored to participant's individual cognitive levels and implemented as a carer-supported intervention. Feasibility of recruitment, retention and implementation of intervention were recorded through observation and documented in field notes. Adherence, carer burden and use of task simplification strategies were also monitored. Outcome measures, collected at 12 weeks included physiological, fear of falling, cognitive and functional measures.
  
  
  RESULTS
  Recruitment was achievable but may be more challenging in a multisite trial. Twenty two dyads of persons with mild dementia and their carers were randomised to intervention or usual care control group. Of 38 dyads referred to the study, there was a high rate of willingness to participate, with 6 (16%) declining and 10 (26%) not meeting inclusion criteria. The intervention was well received by participants and carers and adherence to both program components was very good. All participants implemented some home safety recommendations (range 19-80%) with half implementing 50% or more. At the end of 12 weeks, 72% of the intervention group were exercising. Both the rate of falling and the risk of a fall were lower in the intervention group but these findings were not significant (RR= 0.50 (95% CI 0.11-2.19). There were no differences in physiological outcome measures between the control and intervention groups. However results were influenced by the small study size and incomplete data primarily in the intervention group at follow up.
  
  
  CONCLUSIONS
  The pilot study was feasible and acceptable to people with mild dementia and their carers. The lessons learnt included: recruitment for a larger trial will require multiple approaches; home safety recommendations should provide a greater emphasis on environmental use compared with behavioural change; strategies to ensure an adequate dosage of exercise should be further explored. We recommend that intervention delivery incorporate an integrated occupational therapy and physiotherapy approach and that carers be provided with an individualised session to enhance dementia-specific skills in management and communication. A refined intervention should be tested in a randomised trial with an adequately powered sample size.
  
  
  BACKGROUND
  Australia and New Zealand Clinical Trials Registry 126100001049066.
authors.affiliation: Ageing Work and Health Research Unit, University of Sydney, Lidcombe, Australia. lindy.clemson@sydney.edu.au.
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Wesson
authors.forename: Lindy
authors.initials: L
authors.lastname: Clemson
authors.forename: Henry
authors.initials: H
authors.lastname: Brodaty
authors.forename: Stephen
authors.initials: S
authors.lastname: Lord
authors.forename: Morag
authors.initials: M
authors.lastname: Taylor
authors.forename: Laura
authors.initials: L
authors.lastname: Gitlin
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Close
mesh_terms: D000056:Accident Prevention / Q000379:methods*; D000058:Accidental Falls / Q000517:prevention & control*; D000368:Aged; D000369:Aged, 80 and over; D003704:Dementia / Q000523:psychology* / Q000534:rehabilitation / Q000628:therapy*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D009788:Occupational Therapy / Q000379:methods*; D026741:Physical Therapy Modalities; D010865:Pilot Projects; D016037:Single-Blind Method