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

摘要

Introduction: Apathy, agitated behaviours, lonelinessudand depression are common consequences ofuddementia. This trial aims to evaluate the effect of audrobotic animal on behavioural and psychologicaludsymptoms of dementia in people with dementia livingudin long-term aged care.ududMethods and analysis: A cluster-randomisedudcontrolled trial with three treatment groups: PAROud(robotic animal), Plush-Toy (non-robotic PARO) orudUsual Care (Control). The nursing home sites areudAustralian Government approved and accreditedudfacilities of 60 or more beds. The sites are located inudSouth-East Queensland, Australia. A sample of 380udadults with a diagnosis of dementia, aged 60 years orudolder living in one of the participating facilities will beudrecruited. The intervention consists of three individualud15 min non-facilitated sessions with PARO or Plush-udToy per week, for a period of 10 weeks. The primaryudoutcomes of interest are improvement in agitation,udmood states and engagement. Secondary outcomesudinclude sleep duration, step count, change inudpsychotropic medication use, change in treatmentudcosts, and staff and family perceptions of PARO orudPlush-Toy. Video data will be analysed using NoldusudXT Pocket Observer; descriptive statistics will be usedudfor participants’ demographics and outcome measures;udcluster and individual level analyses to test alludhypotheses and Generalised Linear Models for clusterudlevel and Generalised Estimation Equations and/orudMulti-level Modeling for individual level data.ududEthics and dissemination: The study participants orudtheir proxy will provide written informed consent. TheudGriffith University Human Research Ethics Committeeudhas approved the study (NRS/03/14/HREC). The resultsudof the study will provide evidence of the efficacy of audrobotic animal as a psychosocial treatment for theudbehavioural and psychological symptoms of dementia.udFindings will be presented at local and internationaludconference meetings and published in peer-reviewedudjournals.