Wendy Moyle1, Cindy J Jones2, Jenny E Murfield2, Lukman Thalib3, Elizabeth R A Beattie4, David K H Shum5, Siobhan T O'Dwyer6, M Cindy Mervin7, Brian M Draper8. 1. Menzies Health Institute Queensland, Griffith University, Nathan, Brisbane, Queensland, Australia; School of Nursing and Midwifery, Nathan Campus, Griffith University, Nathan, Brisbane, Queensland, Australia. Electronic address: w.moyle@griffith.edu.au. 2. Menzies Health Institute Queensland, Griffith University, Nathan, Brisbane, Queensland, Australia; School of Nursing and Midwifery, Nathan Campus, Griffith University, Nathan, Brisbane, Queensland, Australia. 3. Department of Public Health, College of Health Sciences, Qatar University, Qatar. 4. School of Nursing, Queensland University of Technology, Kelvin Grove, Brisbane, Queensland, Australia. 5. Menzies Health Institute Queensland, Griffith University, Nathan, Brisbane, Queensland, Australia; School of Applied Psychology, Mt Gravatt Campus, Griffith University, Brisbane, Queensland, Australia. 6. Menzies Health Institute Queensland, Griffith University, Nathan, Brisbane, Queensland, Australia; Medical School, University of Exeter, Exeter, United Kingdom. 7. Menzies Health Institute Queensland, Griffith University, Nathan, Brisbane, Queensland, Australia; Center for Applied Health Economics, School of Medicine, Nathan Campus, Griffith University, Nathan, Brisbane, Queensland, Australia. 8. School of Psychiatry, University of New South Wales, Sydney, Australia.
Abstract
OBJECTIVES: 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. DESIGN: Parallel, 3-group, cluster-randomized controlled trial conducted between June 14, 2014, and May 16, 2015. SETTING:Twenty-eight long-term care facilities operated by 20 care organizations located in South-East Queensland, Australia. PARTICIPANTS: Four hundred fifteen participants aged ≥60 years, with a documented diagnosis of dementia. INTERVENTION: 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. MEASUREMENTS: 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). RESULTS: 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. CONCLUSIONS: Although more effective than usual care in improving mood states and agitation, PARO was only more effective than a plush toy in encouraging engagement.
RCT Entities:
OBJECTIVES: 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. DESIGN: Parallel, 3-group, cluster-randomized controlled trial conducted between June 14, 2014, and May 16, 2015. SETTING: Twenty-eight long-term care facilities operated by 20 care organizations located in South-East Queensland, Australia. PARTICIPANTS: Four hundred fifteen participants aged ≥60 years, with a documented diagnosis of dementia. INTERVENTION: 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. MEASUREMENTS: 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). RESULTS: 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. CONCLUSIONS: Although more effective than usual care in improving mood states and agitation, PARO was only more effective than a plush toy in encouraging engagement.
Authors: Bryanna Streit LaRose; Lisa Kirk Wiese; María de Los Ángeles Ortega Hernández Journal: Issues Ment Health Nurs Date: 2021-10-13 Impact factor: 1.790
Authors: Claire E Sexton; Kaarin J Anstey; Filippo Baldacci; C J Barnum; Anna M Barron; Kaj Blennow; Henry Brodaty; Samantha Burnham; Fanny M Elahi; Jürgen Götz; Yun-Hee Jeon; Maya Koronyo-Hamaoui; Susan M Landau; Nicola T Lautenschlager; Simon M Laws; Darren M Lipnicki; Hanzhang Lu; Colin L Masters; Wendy Moyle; Akinori Nakamura; Giulio Maria Pasinetti; Naren Rao; Christopher Rowe; Perminder S Sachdev; Peter R Schofield; Einar M Sigurdsson; Kate Smith; Velandai Srikanth; Cassandra Szoeke; Malú G Tansey; Rachel Whitmer; Donna Wilcock; Tien Y Wong; Lisa J Bain; Maria C Carrillo Journal: Alzheimers Dement Date: 2021-05-31 Impact factor: 16.655