title: The study protocol of a cluster-randomised controlled trial of family-mediated personalised activities for nursing home residents with dementia.
abstract: BACKGROUND
  Following admission to a nursing home, the feelings of depression and burden that family carers may experience do not necessarily diminish. Additionally, they may experience feelings of guilt and grief for the loss of a previously close relationship. At the same time, individuals with dementia may develop symptoms of depression and agitation (BPSD) that may be related to changes in family relationships, social interaction and stimulation. Until now, interventions to alleviate carer stress and BPSD have treated carers and relatives separately rather than focusing on maintaining or enhancing their relationships. One-to-one structured activities have been shown to reduce BPSD and also improve the caring experience, but barriers such as a lack of resources impede the implementation of activities in aged care facilities. The current study will investigate the effect of individualised activities based on the Montessori methodology administered by family carers in residential care.
  
  
  METHODS
  We will conduct a cluster-randomised trial to train family carers in conducting personalised one-to-one activities based on the Montessori methodology with their relatives. Montessori activities derive from the principles espoused by Maria Montessori and subsequent educational theorists to promote engagement in learning, namely task breakdown, guided repetition, progression in difficulty from simple to complex, and the careful matching of demands to levels of competence. Persons with dementia living in aged care facilities and frequently visiting family carers will be included in the study. Consented, willing participants will be randomly assigned by facility to a treatment condition using the Montessori approach or a control waiting list condition. We hypothesise that family carers conducting Montessori-based activities will experience improvements in quality of visits and overall relationship with the resident as well as higher self-rated mastery, fewer depressive symptoms, and a better quality of life than carers in the waiting list condition.
  
  
  CONCLUSIONS
  We hypothesise that training family carers to deliver personalised activities to their relatives in a residential setting will make visits more satisfying and may consequently improve the quality of life for carers and their relatives. These beneficial effects might also reduce nursing staff burden and thus impact positively on residential facilities.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trials Registry - ACTRN12611000998943.
authors.affiliation: Aged Mental Health Research Unit, Monash University, Melbourne Australia, Postal address: Kingston Centre, Warrigal Road, Cheltenham, Vic 3192, Australia. Eva.vanderPloeg@monash.edu
authors.forename: Eva S
authors.initials: ES
authors.lastname: van der Ploeg
authors.forename: Cameron J
authors.initials: CJ
authors.lastname: Camp
authors.forename: Barbara
authors.initials: B
authors.lastname: Eppingstall
authors.forename: Susannah J
authors.initials: SJ
authors.lastname: Runci
authors.forename: Daniel W
authors.initials: DW
authors.lastname: O'Connor
mesh_terms: D017028:Caregivers / Q000523:psychology / Q000592:standards; D016000:Cluster Analysis; D003704:Dementia / Q000523:psychology / Q000628:therapy*; D005195:Family Relations; D006801:Humans; D017008:Negotiating / Q000379:methods* / Q000523:psychology; D009735:Nursing Homes / Q000592:standards; D057285:Precision Medicine / Q000379:methods* / Q000592:standards