Can lifelike baby dolls reduce symptoms of anxiety, agitation, or aggression for people with dementia in long-term care? Findings from a pilot randomised controlled trial

To compare a lifelike baby doll intervention for reducing anxiety, agitation, and aggression in older people with dementia in long-term care (LTC), with usual facility care; and explore the perceptions of care staff about doll therapy.Pilot, mixed-methods, parallel, randomised controlled trial, with follow-up semi-structured interviews. Thirty-five residents from five LTC facilities in Queensland, Australia were randomised to the lifelike baby doll intervention (three, 30-minute, individual, non-facilitated sessions per week) or usual care. Outcomes were changes in levels of anxiety, agitation, and aggression after the 3-week intervention, and short-term effects at week 1. Following intention-to-treat principles, repeated measure MANOVA was undertaken. Qualitative interviews involved five staff.The doll intervention did not significantly reduce residents' anxiety, agitation, or aggression when compared to usual care at weeks 3 (primary outcome) and 1 (secondary outcome). However, there was a significant group-by-time interaction for the outcome of pleasure - the doll group showed a greater increase in displays of pleasure at week 3 compared to baseline than usual care (F(1,31) = 4.400, p = 0.044; Cohen's d = 0.74). Staff perceived benefits for residents included emotional comfort, a calming effect, and providing a purposeful activity. Perceived limitations were that doll therapy may only be suitable for some individuals, some of the time, and the potential for residents to care for the doll at the expense of their health.Doll therapy can provide some residents with enjoyment and purposeful engagement. Further research should focus on understanding the individual characteristics and circumstances in which residents most benefit

Using a therapeutic companion robot for dementia symptoms in long-term care: reflections from a cluster-RCT

OBJECTIVES: We undertook a cluster-randomised controlled trial exploring the effect of a therapeutic companion robot (PARO) compared to a look-alike plush toy and usual care on dementia symptoms of long-term care residents. Complementing the reported quantitative outcomes , this paper provides critical reflection and commentary on individual participant responses to PARO, observed through video recordings , with a view to informing clinical practice and research. METHOD: A descriptive, qualitative design with five participants selected from the PARO intervention arm of the trial. The trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12614000508673). RESULTS: The five participants and their responses to PARO are presented in terms of three issues: i.) Different pre-intervention clinical presentations and different responses; ii.) Same individual, different response - the need for continual assessment and review; and iii.) The ethics of giving and retrieving PARO. Implications for clinical practice and future research are discussed in relation to each issue. CONCLUSION: The findings suggest that one approach does not fit all, and that there is considerable variation in responses to PARO. A number of recommendations are discussed to aid the delivery of psychosocial interventions with PARO in practice, as well as to guide future research

Use of a Robotic Seal as a Therapeutic Tool to Improve Dementia Symptoms: A Cluster-Randomized Controlled Trial

To test the effects of individual, nonfacilitated sessions with PARO (version 9), when compared against a look-alike plush toy and usual care, on the emotional and behavioral symptoms of dementia for people living in long-term care facilities. Parallel, 3-group, cluster-randomized controlled trial conducted between June 14, 2014, and May 16, 2015. Twenty-eight long-term care facilities operated by 20 care organizations located in South-East Queensland, Australia. Four hundred fifteen participants aged ≥60 years, with a documented diagnosis of dementia. Stratified by private/not-for-profit status and randomized using a computer-generated sequence, 9 facilities were randomized to the PARO group (individual, nonfacilitated, 15-minute sessions 3 times per week for 10 weeks); 10 to plush toy (same, but given PARO with robotic features disabled); and 9 to usual care. Treatment allocation was masked to assessors. Primary outcomes were changes in levels of engagement, mood states, and agitation after a 10-week intervention, assessed by coded video observations (baseline, weeks 1, 5, 10, and 15) and Cohen-Mansfield Agitation Inventory-Short Form (baseline, weeks 10 and 15). Analyses followed intention-to-treat, using repeated measures mixed effects models. Australian New Zealand Clinical Trials Registry (ACTRN12614000508673). Video data showed that participants in the PARO group were more verbally [3.61, 95% confidence interval (CI): 6.40-0.81, P = .011] and visually engaged (13.06, 95% CI: 17.05-9.06, P < .0001) than participants in plush toy. Both PARO (-3.09, 95% CI: -0.45 to -5.72, P = .022) and plush toy (-3.58, 95% CI: -1.26 to -5.91, P = .002) had significantly greater reduced neutral affect compared with usual care, whilst PARO was more effective than usual care in improving pleasure (1.12, 95% CI: 1.94-0.29, P = .008). Videos showed that PARO was more effective than usual care in improving agitation (3.33, 95% CI: 5.79-0.86, P = .008). When measured using the CMAI-SF, there was no difference between groups. Although more effective than usual care in improving mood states and agitation, PARO was only more effective than a plush toy in encouraging engagement.Australian National Health and Medical Research Council [APP1065320