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.
BACKGROUND
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
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.


BACKGROUND
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.


BACKGROUND
Australian and New Zealand Clinical Trials Registry number ACTRN12614000508673 date registered 13/05/2014.
Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia Centre for Health Practice Innovation, Griffith University, Brisbane, Queensland, Australia Dementia Collaborative Research Centre, Queensland University of Technology, Brisbane, Queensland, Australia.
Wendy
W
Moyle
Dementia Collaborative Research Centre, Queensland University of Technology, Brisbane, Queensland, Australia.
Elizabeth
http://orcid.org/0000-0002-9779-0605
E
Beattie
School of Psychiatry and Dementia Collaborative Research Centre, University of NSW, Sydney, Australia.
Brian
B
Draper
Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia Behavioural Basis of Health, Griffith University, Brisbane, Queensland, Australia.
David
http://orcid.org/0000-0002-4810-9262
D
Shum
Faculty of Medicine, Kuwait University, Kuwait City, Kuwait.
Lukman
L
Thalib
Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia Centre for Health Practice Innovation, Griffith University, Brisbane, Queensland, Australia.
Cindy
http://orcid.org/0000-0002-7249-2580
C
Jones
Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia Centre for Health Practice Innovation, Griffith University, Brisbane, Queensland, Australia Dementia Collaborative Research Centre, Queensland University of Technology, Brisbane, Queensland, Australia.
Siobhan
S
O'Dwyer
Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia Centre for Applied Health Economics, Griffith University, Brisbane, Queensland, Australia.
Cindy
C
Mervin
D000339:Affect; D000368:Aged; D001315:Australia; D003365:Costs and Cost Analysis; D003704:Dementia / Q000523:psychology* / Q000628:therapy*; D006707:Homes for the Aged; D006801:Humans; D008875:Middle Aged; D009735:Nursing Homes; D010342:Patient Acceptance of Health Care; D010988:Play and Playthings; D011595:Psychomotor Agitation; D011619:Psychotropic Drugs / Q000627:therapeutic use; D011793:Queensland; D012371:Robotics / Q000191:economics; D012890:Sleep
D011619:Psychotropic Drugs