Effect of an interactive therapeutic robotic animal on engagement, mood states, agitation and psychotropic drug use in people with dementia: a cluster-randomised controlled trial protocol Wendy Moyle, 1,2,3 Elizabeth Beattie, 3 Brian Draper, 4 David Shum, 1,5 Lukman Thalib, 6 Cindy Jones, 1,2 Siobhan O’Dwyer, 1,2,3 Cindy Mervin 1,7 To cite: Moyle W, Beattie E, Draper B, et al. Effect of an interactive therapeutic robotic animal on engagement, mood states, agitation and psychotropic drug use in people with dementia: a cluster-randomised controlled trial protocol. BMJ Open 2015;5:e009097. doi:10.1136/bmjopen-2015- 009097 ▸ Prepublication history for this paper is available online. To view these files please visit the journal online (http://dx.doi.org/10.1136/ bmjopen-2015-009097). Received 16 June 2015 Revised 16 July 2015 Accepted 23 July 2015 For numbered affiliations see end of article. Correspondence to Professor Wendy Moyle; w.moyle@griffith.edu.au ABSTRACT Introduction: Apathy, agitated behaviours, loneliness and depression are common consequences of dementia. This trial aims to evaluate the effect of a robotic animal on behavioural and psychological symptoms of dementia in people with dementia living in long-term aged care. Methods and analysis: A cluster-randomised controlled trial with three treatment groups: PARO (robotic animal), Plush-Toy (non-robotic PARO) or Usual Care (Control). The nursing home sites are Australian Government approved and accredited facilities of 60 or more beds. The sites are located in South-East Queensland, Australia. A sample of 380 adults with a diagnosis of dementia, aged 60 years or older living in one of the participating facilities will be recruited. The intervention consists of three individual 15 min non-facilitated sessions with PARO or Plush- Toy per week, for a period of 10 weeks. The primary outcomes of interest are improvement in agitation, mood states and engagement. Secondary outcomes include sleep duration, step count, change in psychotropic medication use, change in treatment costs, and staff and family perceptions of PARO or Plush-Toy. Video data will be analysed using Noldus XT Pocket Observer; descriptive statistics will be used for participants’ demographics and outcome measures; cluster and individual level analyses to test all hypotheses and Generalised Linear Models for cluster level and Generalised Estimation Equations and/or Multi-level Modeling for individual level data. Ethics and dissemination: The study participants or their proxy will provide written informed consent. The Griffith University Human Research Ethics Committee has approved the study (NRS/03/14/HREC). The results of the study will provide evidence of the efficacy of a robotic animal as a psychosocial treatment for the behavioural and psychological symptoms of dementia. Findings will be presented at local and international conference meetings and published in peer-reviewed journals. Trial registration number: Australian and New Zealand Clinical Trials Registry number ACTRN12614000508673 date registered 13/05/2014. INTRODUCTION Background Approximately 35.6 million people globally and 330 000 Australians 1 have dementia. With the ageing of the population, this number is expected to double every 20 years. 2 Dementia is one of the major reasons for admission into long-term aged care. People with dementia may present with agitated behaviours that cause stress for the person him/herself, those who care for them, and other residents in care facilities. Apathy, loneliness and depression also com- monly occur in people with dementia and can make it challenging for care staff to engage them in meaningful activities, which in turn places them at high risk for further Strengths and limitations of this study ▪ The study proposes the assessment of a novel technology that people with dementia can inter- act with. ▪ The strengths of the study include its relatively large sample size, three treatment groups, long- term sustainability follow-up, video and physio- logical data and comparative cost analysis. ▪ Limitations include the intervention being con- ducted only during the afternoon rather than at the onset of agitation, and no comparison between a live animal and robot animal. Moyle W, et al. BMJ Open 2015;5:e009097. doi:10.1136/bmjopen-2015-009097 1 Open Access Protocol