Effectiveness and Cost-Effectiveness of Robot Therapy With the Paro Robot in People Living With Dementia
NCT ID: NCT05884424
Last Updated: 2023-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
123 participants
INTERVENTIONAL
2023-04-10
2023-10-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The evaluation will be carried out through a multicenter pragmatic clinical trial randomized to an intervention group (PARO therapy robot) or a control group (treatment as usual). Participants in the intervention group will complete three sessions per week with the PARO therapy robot during 12 weeks. Participants in the control group will maintain their standard care. In addition, a follow-up evaluation will be made three months after the end of the intervention to assess the duration of the possible effects.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pilot Study of a Robot-assisted Intervention for the Management of Care-induced Pain in Dementia
NCT03591822
Psycho-social Intervention With Paro Robotic Seal Focused on Patients With Dementia
NCT05626205
The Use of PARO to Decrease Agitation in Persons With Dementia and/or Delirium
NCT05565703
Exploring the Impact of Dementia Prevention Programs Using Robots as Intervention Tools on Community Elderly
NCT06984458
Assessing the Effects of Robotic Pets on Patients With Dementia in the Acute Care Hospital Setting
NCT06683443
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Due to the deficiencies of the existing drugs, non-pharmacological therapies (NPT) are particularly relevant in the management of dementia. A NPT is any non-chemical, theoretically supported, focused and replicable intervention that is potentially able to produce a relevant benefit. Among these NPT, mention must be made of robot therapy, which involves the use of robots that simulate animals and are equipped with artificial intelligence and multiple sensors that allow them to behave and interact with users as if they were a real animal.
Therapy robots are regarded as an alternative to animal-assisted therapy, avoiding complications arising from the presence of animals while affording similar effects. The Personal Assistant Robot (PARO) robot seal was developed with this purpose in mind. It is the most widely used robot in the field of dementia, and also the most widely studied robot. Designed in Japan by Professor T. Shibata, PARO is an interactive robot with five types of sensors (light, touch, posture, temperature and sound), and it has demonstrated the ability to provide social and emotional stimulation.
In people living with dementia, robot therapy has been shown to offer psychological benefits (improved relaxation and motivation), physiological benefits (improved vital signs) and social benefits (stimulation of communication). In addition, the most recent studies have shown robot therapy to exert positive effects upon cognitive function, agitation, anxiety, depression, other neuropsychiatric symptoms and quality of life. However, other reviews have not recorded sufficient evidence of the positive effects of robot therapy upon cognition, neuropsychiatric symptoms or quality of life. Further quality studies are therefore needed on the effect of robot therapy in people living with dementia.
In this regard, the proposed study is aimed at evaluating the effectiveness and cost-effectiveness of group robot therapy intervention with the PARO robot in terms of quality of life and neuropsychiatric symptoms in people living with dementia in residential centers. In addition, the acceptability of the intervention on the part of the users participating in the study will be evaluated. For this purpose, a multicenter study will be carried out in the form of a randomized clinical trial in which the selected participants will be randomized to an intervention group (PARO Therapy Robot) or a control group (standard care).
Hypothesis:
* After the intervention, participants in the experimental group will improve their quality of life scores compared with the control group receiving standard care, where scores will be maintained or will get worse.
* Participants in the experimental group will have fewer neuropsychiatric alterations than participants in the control group.
* Participants in the experimental group will reduce their depression scores versus participants in the control group.
* Participants in the experimental group will experience less agitation than participants in the control group.
* Participants in the experimental group will experience less apathy than participants in the control group.
* The PARO robot will be well accepted by the individuals living with dementia.
* PARO Therapy Robot will be efficient in comparison with standard care. Objectives
The primary study objective is:
• To compare the effectiveness of the PARO Therapy Robot and standard care in improving the quality of life of people with dementia living in residential centers.
The secondary objectives are:
* To compare the effectiveness of the PARO Therapy Robot and standard care in reducing neuropsychiatric disorders in people with dementia. Specifically, efficacy will be compared in terms of:
* Reducing depressive symptoms.
* Reducing agitation.
* Reducing apathy.
* To evaluate the acceptability of the PARO robot on the part of the patients.
* To perform a cost-effectiveness and cost-utility analysis, comparing the direct costs of the PARO Therapy Robot and standard care with the results afforded by the two alternatives.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
The person from CREA - Imserso in charge of randomization and data analysis will also be blinded.
The participants and the technician implementing the intervention cannot be blinded, due to the inherent nature of the intervention.
Data analysis will also be performed blinded.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PARO Therapy Robot
Participants allocated to the PARO Therapy Robot group will undergo three group robot therapy sessions per week for 12 weeks, in addition to continuing their standard care.
PARO Therapy Robot
Participants allocated to the PARO Therapy Robot group will receive three group robot therapy sessions per week for 12 weeks, in addition to continuing their standard care.
Robot therapy session will last 20 minutes. The sessions will be partially guided, intending to allow participants to interact with the robot seal freely for as long as possible, but redirecting the activity if necessary. The sessions will be conducted in group format, in groups of 4 users, with participants sitting in a circle around a table. The professional conducting the sessions will be a therapist with experience in NPT for people living with dementia, and who has attended the training session on the study intervention protocol.
The sessions will be structured as follows:
1. Welcome and presentation.
2. Main activity with PARO.
3. PARO cleaning.
4. End of session. A total of 13 different sessions are proposed, to be conducted in a cyclical manner (each session 3 times, except sessions 1 and 2).
Control
Participants in the control group will maintain their standard care, participating in those activities previously assigned in their individual care plan.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PARO Therapy Robot
Participants allocated to the PARO Therapy Robot group will receive three group robot therapy sessions per week for 12 weeks, in addition to continuing their standard care.
Robot therapy session will last 20 minutes. The sessions will be partially guided, intending to allow participants to interact with the robot seal freely for as long as possible, but redirecting the activity if necessary. The sessions will be conducted in group format, in groups of 4 users, with participants sitting in a circle around a table. The professional conducting the sessions will be a therapist with experience in NPT for people living with dementia, and who has attended the training session on the study intervention protocol.
The sessions will be structured as follows:
1. Welcome and presentation.
2. Main activity with PARO.
3. PARO cleaning.
4. End of session. A total of 13 different sessions are proposed, to be conducted in a cyclical manner (each session 3 times, except sessions 1 and 2).
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Persons over 60 years of age.
* A diagnosis of mild to moderate dementia (of any type) (Mini-Mental State Examination \[MMSE\] score between 13-25).
* Patients who have not previously participated in intervention sessions with the PARO robot and who do not participate in other robotic or animal-assisted interventions during the course of the study.
* Signing of informed consent by the person with dementia or the legal guardian.
* No firm and obvious rejection of the PARO therapy robot.
Exclusion Criteria
* Health issues that advise against or impede participation in the sessions.
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Asturhealth SL
UNKNOWN
Servicio de Evaluación y Planificación del Servicio Canario de la Salud (SESCS)
UNKNOWN
Instituto de Mayores y Servicios Sociales (IMSERSO)
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Enrique Perez Saez
Neuropsychologist
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Enrique Perez, Phd
Role: STUDY_DIRECTOR
Centro de Referencia Estatal de atención a personas con enfermedad de Alzheimer y otras demencias - Imserso
Teresa Rodriguez, MSc
Role: PRINCIPAL_INVESTIGATOR
Centro de Referencia Estatal de atención a personas con enfermedad de Alzheimer y otras demencias - Imserso
Mireia Tofiño, MSc
Role: PRINCIPAL_INVESTIGATOR
Centro de Referencia Estatal de atención a personas con enfermedad de Alzheimer y otras demencias - Imserso
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
ATENDO Calidade S.L
Vigo, Pontevedra, Spain
Centro Residencial CleceVitam Bastiagueiro
A Coruña, , Spain
Residencia DomusVi Alcoi
Alicante, , Spain
Residencia DomusVi Alicante Babel
Alicante, , Spain
Residencia CleceVitam San Pedro Poveda
Burgos, , Spain
Residencia DomusVi Vila-Real
Castelló, , Spain
Residencia CleceVitam Ponent
Lleida, , Spain
Residencia de Mayores Albertia Moratalaz
Madrid, , Spain
Residencia ORPEA Madrid Buenavista
Madrid, , Spain
Residencia ORPEA Pinto
Madrid, , Spain
Centro Residencial CleceVitam Carmen Conde
Murcia, , Spain
Residencia Bañosalud
Palencia, , Spain
Residencia CleceVitam San Antonio
Salamanca, , Spain
CleceVitam Gerohotel
Valladolid, , Spain
Residencia León Trucíos
Vizcaya, , Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Bemelmans R, Gelderblom GJ, Jonker P, de Witte L. Socially assistive robots in elderly care: a systematic review into effects and effectiveness. J Am Med Dir Assoc. 2012 Feb;13(2):114-120.e1. doi: 10.1016/j.jamda.2010.10.002. Epub 2010 Dec 15.
2021 Alzheimer's disease facts and figures. Alzheimers Dement. 2021 Mar;17(3):327-406. doi: 10.1002/alz.12328. Epub 2021 Mar 23.
Asl AM, Toribio-Guzman JM, van der Roest H, Castro-Gonzalez A, Malfaz M, Salichs MA, Martin MF. The usability and feasibility validation of the social robot MINI in people with dementia and mild cognitive impairment; a study protocol. BMC Psychiatry. 2022 Dec 5;22(1):760. doi: 10.1186/s12888-022-04418-9.
Cohen-Mansfield J, Marx MS, Rosenthal AS. A description of agitation in a nursing home. J Gerontol. 1989 May;44(3):M77-84. doi: 10.1093/geronj/44.3.m77.
Frings L, Yew B, Flanagan E, Lam BY, Hull M, Huppertz HJ, Hodges JR, Hornberger M. Longitudinal grey and white matter changes in frontotemporal dementia and Alzheimer's disease. PLoS One. 2014 Mar 3;9(3):e90814. doi: 10.1371/journal.pone.0090814. eCollection 2014.
Hernandez G, Garin O, Pardo Y, Vilagut G, Pont A, Suarez M, Neira M, Rajmil L, Gorostiza I, Ramallo-Farina Y, Cabases J, Alonso J, Ferrer M. Validity of the EQ-5D-5L and reference norms for the Spanish population. Qual Life Res. 2018 Sep;27(9):2337-2348. doi: 10.1007/s11136-018-1877-5. Epub 2018 May 16.
Kang HS, Makimoto K, Konno R, Koh IS. Review of outcome measures in PARO robot intervention studies for dementia care. Geriatr Nurs. 2020 May-Jun;41(3):207-214. doi: 10.1016/j.gerinurse.2019.09.003. Epub 2019 Oct 24.
Logsdon RG, Gibbons LE, McCurry SM, Teri L. Assessing quality of life in older adults with cognitive impairment. Psychosom Med. 2002 May-Jun;64(3):510-9. doi: 10.1097/00006842-200205000-00016.
Moniz-Cook E, Vernooij-Dassen M, Woods R, Verhey F, Chattat R, De Vugt M, Mountain G, O'Connell M, Harrison J, Vasse E, Droes RM, Orrell M; INTERDEM group. A European consensus on outcome measures for psychosocial intervention research in dementia care. Aging Ment Health. 2008 Jan;12(1):14-29. doi: 10.1080/13607860801919850.
Moyle W, Bramble M, Jones CJ, Murfield JE. "She Had a Smile on Her Face as Wide as the Great Australian Bite": A Qualitative Examination of Family Perceptions of a Therapeutic Robot and a Plush Toy. Gerontologist. 2019 Jan 9;59(1):177-185. doi: 10.1093/geront/gnx180.
O'Shea E, Devane D, Murphy K, Cooney A, Casey D, Jordan F, Hunter A, Murphy E. Effectiveness of a structured education reminiscence-based programme for staff on the quality of life of residents with dementia in long-stay units: a study protocol for a cluster randomised trial. Trials. 2011 Feb 14;12:41. doi: 10.1186/1745-6215-12-41.
Peters F, Villeneuve S, Belleville S. Predicting progression to dementia in elderly subjects with mild cognitive impairment using both cognitive and neuroimaging predictors. J Alzheimers Dis. 2014;38(2):307-18. doi: 10.3233/JAD-130842.
Pu L, Moyle W, Jones C. How people with dementia perceive a therapeutic robot called PARO in relation to their pain and mood: A qualitative study. J Clin Nurs. 2020 Feb;29(3-4):437-446. doi: 10.1111/jocn.15104. Epub 2019 Dec 2.
Martin Rico F, Rodriguez-Lera FJ, Gines Clavero J, Guerrero-Higueras AM, Matellan Olivera V. An Acceptance Test for Assistive Robots. Sensors (Basel). 2020 Jul 14;20(14):3912. doi: 10.3390/s20143912.
Saragih ID, Tonapa SI, Sun TL, Chia-Ju L, Lee BO. Effects of robotic care interventions for dementia care: A systematic review and meta-analysis randomised controlled trials. J Clin Nurs. 2021 Nov;30(21-22):3139-3152. doi: 10.1111/jocn.15856. Epub 2021 May 26.
Shibata T, Wada K. Robot therapy: a new approach for mental healthcare of the elderly - a mini-review. Gerontology. 2011;57(4):378-86. doi: 10.1159/000319015. Epub 2010 Jul 15.
Yesavage JA, Brink TL, Rose TL, Lum O, Huang V, Adey M, Leirer VO. Development and validation of a geriatric depression screening scale: a preliminary report. J Psychiatr Res. 1982-1983;17(1):37-49. doi: 10.1016/0022-3956(82)90033-4.
Yu C, Sommerlad A, Sakure L, Livingston G. Socially assistive robots for people with dementia: Systematic review and meta-analysis of feasibility, acceptability and the effect on cognition, neuropsychiatric symptoms and quality of life. Ageing Res Rev. 2022 Jun;78:101633. doi: 10.1016/j.arr.2022.101633. Epub 2022 Apr 21.
Agüera-Ortiz L, Cruz-Orduña I, Ramos-García MI, Valentí-Soler, M, Gil-Ruiz N, Osorio-Suárez RM, Dobato JL, Olazarán-Rodríguez J, León-Salas B, Martínez-Martín P. Proceso de creación de la escala APADEM-NH para la medición de la apatía en pacientes con demencia institucionalizados. Psicogeriatría. 2011; 3: 29-36.
Cervilla J, Rodríguez A, Hoyos G, Mínguez L, González E. Agitación y deterioro cognitivo usando la versión española del Inventario de agitación del anciano de Cohen-Mansfield. Psiquiatria.com-Revista internacional online. 2002; 6(5): 1-10.
Glick HA, Doshi JA, Sonnad SS, Polsky D. Economic evaluation in clinical trials. 1st. ed. Oxford: Oxford University Press; 2007.
Gomez-Gallego M, Gomez-Amor J, Gomez-Garcia J. [Validation of the Spanish version of the QoL-AD Scale in alzheimer disease patients, their carers, and health professionals]. Neurologia. 2012 Jan;27(1):4-10. doi: 10.1016/j.nrl.2011.03.006. Epub 2011 May 12. Spanish.
Inoue T, Nihei M, Narita T, Onoda M, Ishiwata R, Mamiya I, Shino M, Kojima H, Ohnaka S, Fujita Y, Kamata M. Field-based development of an information support robot for persons with dementia. Technology and Disability. 2012; 24(4): 263-271. doi: 10.3233/TAD-120357.
Khosla R, Nguyen K, Chu MT. Human robot engagement and acceptability in residential aged care. International Journal of Human-Computer Interaction. 2017; 33(6): 510-522. doi: 10.1080/10447318.2016.1275435.
Kolling T, Haberstroh J, Kaspar R, Pantel J, Oswald F, Knopf M. Evidence and deployment-based research into care for the elderly using emotional robots: psychological, methodological and cross-cultural facets. GeroPsych: The Journal of Gerontopsychology and Geriatric Psychiatry. 2013; 26(2): 83-88. doi: 10.1024/1662-9647/a000084.
Logsdon RG, Gibbons LE, McCurry SM, Teri L. Quality of life in Alzheimer's disease: patient and caregiver reports. Journal of Mental Health and Aging. 1999; 5(1): 21-32.
Martinez de la Iglesia J, Onis Vilches MC, Duenas Herrero R, Aguado Taberne C, Albert Colomer C, Arias Blanco MC. [Abbreviating the brief. Approach to ultra-short versions of the Yesavage questionnaire for the diagnosis of depression]. Aten Primaria. 2005 Jan;35(1):14-21. doi: 10.1157/13071040. Spanish.
Martínez-Velásquez DA, Chavarro-Carvajal DA, García-Cifuentes E, Venegas-Sanabria LC, Cano-Gutiérrez CA. Caracterización de pacientes con demencia avanzada hospitalizados por el servicio de geriatría en un hospital de alta complejidad. Acta Neurológica Colombiana. 2019; 35(1): 15-21. doi: 10.22379/24224022228.
Moyle W, Jones C, Sung B, Bramble M, O'Dwyer S, Blumenstein M, Estivill-Castro V. What effect does an animal robot called CuDDler have on the engagement and emotional response of older people with dementia? A pilot feasibility study. International Journal of Social Robotics. 2016; 8(1): 145-156. doi: 10.1007/s12369-015-0326-7.
Olazaran J, Reisberg B, Clare L, Cruz I, Pena-Casanova J, Del Ser T, Woods B, Beck C, Auer S, Lai C, Spector A, Fazio S, Bond J, Kivipelto M, Brodaty H, Rojo JM, Collins H, Teri L, Mittelman M, Orrell M, Feldman HH, Muniz R. Nonpharmacological therapies in Alzheimer's disease: a systematic review of efficacy. Dement Geriatr Cogn Disord. 2010;30(2):161-78. doi: 10.1159/000316119. Epub 2010 Sep 10.
Plan integral de Alzheimer y otras demencias (2019-2023). Madrid: Ministerio de Sanidad, Consumo y Bienestar Social; 2019.
Shankar KK, Walker M, Frost D, Orrell MW. The development of a valid and reliable scale for rating anxiety in dementia (RAID). Aging & Mental Health. 1999; 3(1): 39-49. doi: 10.1080/13607869956424.
Sheikh JI, Yesavage, JA. Geriatric Depression Scale (GDS): recent evidence and development of a shorter version. Clinical Gerontologist. 1986; 5: 165-73. doi: 10.1300/J018v05n01_09.
Shibata T, Kawaguchi Y, Wada K. Investigation on people living with seal robot at home. International journal of social robotics. 2012; 4(1): 53-63. doi:10.1007/s12369-011-0111-1.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
04/22
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.