Effectiveness and Cost-Effectiveness of Robot Therapy With the Paro Robot in People Living With Dementia

NCT05884424 | Completed

• 1 other identifier: 04/22
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 15

Brief Summary

The purpose of this study is to evaluate the effectiveness and cost-effectiveness of group robot therapy with the PARO therapy robot in terms of quality of life and neuropsychiatric symptoms in people living with dementia in residential centers. In addition, the acceptability of the robot on the part of the users participating in the study will be evaluated. 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.

Conditions

Dementia; Neurocognitive Disorders; Mild Cognitive Impairment

Keywords

Dementia; Neurocognitive Disorders; Mild Cognitive Impairment; Robot therapy; Quality of life; Neuropsychiatric symptoms; Older adult; Robot; Cost-effectiveness

Outcome Measures

Primary Outcomes (6)

• Quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD)

  Quality of Life - Alzheimer's Disease (QoL-AD). QoL-AD is used to assess quality of life in people with dementia, based on the information provided by the patient (patient version). It consists of 13 items referring to perceived health status, mood, functional capacity, personal and leisure relationships, capacity to decide, and personal life as a whole. Each item is answered on a Likert-type scale from 1 (poor) to 4 (excellent). The score range from 13-52. Higher scores indicate better quality of life. This tool has good psychometric properties, and its use has been recommended by a European consensus to assess psychosocial interventions. The Spanish adaptation of this scale will be used.

  Baseline (T0)

• Change in quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD)

  Quality of Life - Alzheimer's Disease (QoL-AD). QoL-AD is used to assess quality of life in people with dementia, based on the information provided by the patient (patient version). It consists of 13 items referring to perceived health status, mood, functional capacity, personal and leisure relationships, capacity to decide, and personal life as a whole. Each item is answered on a Likert-type scale from 1 (poor) to 4 (excellent). The score range from 13-52. Higher scores indicate better quality of life. This tool has good psychometric properties, and its use has been recommended by a European consensus to assess psychosocial interventions. The Spanish adaptation of this scale will be used.

  12 weeks after the beginning of the intervention (T1)

• Change in quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD)

  Quality of Life - Alzheimer's Disease (QoL-AD). QoL-AD is used to assess quality of life in people with dementia, based on the information provided by the patient (patient version). It consists of 13 items referring to perceived health status, mood, functional capacity, personal and leisure relationships, capacity to decide, and personal life as a whole. Each item is answered on a Likert-type scale from 1 (poor) to 4 (excellent). The score range from 13-52. Higher scores indicate better quality of life. This tool has good psychometric properties, and its use has been recommended by a European consensus to assess psychosocial interventions. The Spanish adaptation of this scale will be used.

  12 weeks after end of the intervention (T2)

• Quality of life evaluated through EQ-5D-5L

  EQ-5D-5L. The EQ-5D-5L is a generic instrument for the assessment of health-related quality of life that can be used in both relatively healthy individuals and in groups of patients with different disease conditions. The individual evaluates his or her own state of health first as severity levels by dimensions (mobility, self-care, daily activities, pain/discomfort and anxiety/depression), and then using a more general evaluation visual analog scale (VAS). A third element is the social values index that is obtained for each health status generated by the instrument. The index ranges from 1 (best health status) to 0 (death), though there are negative values for the index, corresponding to those health statuses that are assessed as being worse than death. In this way we have an index that can be used directly or combined with life years to calculate QALYs (quality-adjusted life years).

  Baseline (T0)

• Change in quality of life evaluated through EQ-5D-5L

  EQ-5D-5L. The EQ-5D-5L is a generic instrument for the assessment of health-related quality of life that can be used in both relatively healthy individuals and in groups of patients with different disease conditions. The individual evaluates his or her own state of health first as severity levels by dimensions (mobility, self-care, daily activities, pain/discomfort and anxiety/depression), and then using a more general evaluation visual analog scale (VAS). A third element is the social values index that is obtained for each health status generated by the instrument. The index ranges from 1 (best health status) to 0 (death), though there are negative values for the index, corresponding to those health statuses that are assessed as being worse than death. In this way we have an index that can be used directly or combined with life years to calculate QALYs (quality-adjusted life years).

  12 weeks after the beginning of the intervention (T1)

• Change in quality of life evaluated through EQ-5D-5L

  EQ-5D-5L. The EQ-5D-5L is a generic instrument for the assessment of health-related quality of life that can be used in both relatively healthy individuals and in groups of patients with different disease conditions. The individual evaluates his or her own state of health first as severity levels by dimensions (mobility, self-care, daily activities, pain/discomfort and anxiety/depression), and then using a more general evaluation visual analog scale (VAS). A third element is the social values index that is obtained for each health status generated by the instrument. The index ranges from 1 (best health status) to 0 (death), though there are negative values for the index, corresponding to those health statuses that are assessed as being worse than death. In this way we have an index that can be used directly or combined with life years to calculate QALYs (quality-adjusted life years).

  12 weeks after end of the intervention (T2)

Secondary Outcomes (9)

• Mood assessed through the Geriatric Depression Scale-15 (GDS-15)

  Baseline (T0)

• Change in mood assessed through the Geriatric Depression Scale-15 (GDS-15)

  12 weeks after the beginning of the intervention (T1)

• Change in mood assessed through the Geriatric Depression Scale-15 (GDS-15)

  12 weeks after end of the intervention (T2)

• Apathy assessed through the Apathy in Dementia-Nursing Home (APADEM-NH)

  Baseline (T0)

• Change in apathy assessed through the Apathy in Dementia-Nursing Home (APADEM-NH)

  12 weeks after the beginning of the intervention (T1)

Other Outcomes (5)

• Psychotropic medication

  Baseline (T0)

• Change in psychotropic medication

  12 weeks after the beginning of the intervention (T1)

• Rescue medication

  12 weeks after the beginning of the intervention (T1)

Study Arms (2)

PARO Therapy Robot

EXPERIMENTAL

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.

Behavioral: PARO Therapy Robot

Control

NO INTERVENTION

Participants in the control group will maintain their standard care, participating in those activities previously assigned in their individual care plan.

Interventions

PARO Therapy Robot BEHAVIORAL

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).

Also known as: PARO

PARO Therapy Robot

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Residents of the sites participating in the study.
• 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.

You may not qualify if:

• Presence of sensory limitations that preclude participation in the sessions.
• Health issues that advise against or impede participation in the sessions.

Sponsors & Collaborators

• Instituto de Mayores y Servicios Sociales (IMSERSO): lead
• Asturhealth SL: collaborator
• Servicio de Evaluación y Planificación del Servicio Canario de la Salud (SESCS): collaborator

Study Sites (15)

ATENDO Calidade S.L

Vigo, Pontevedra, Spain

Location

Centro Residencial CleceVitam Bastiagueiro

A Coruña, Spain

Location

Residencia DomusVi Alcoi

Alicante, Spain

Location

Residencia DomusVi Alicante Babel

Alicante, Spain

Location

Residencia CleceVitam San Pedro Poveda

Burgos, Spain

Location

Residencia DomusVi Vila-Real

Castelló, Spain

Location

Residencia CleceVitam Ponent

Lleida, Spain

Location

Residencia de Mayores Albertia Moratalaz

Madrid, 28030, Spain

Location

Residencia ORPEA Madrid Buenavista

Madrid, Spain

Location

Residencia ORPEA Pinto

Madrid, Spain

Location

Centro Residencial CleceVitam Carmen Conde

Murcia, Spain

Location

Residencia Bañosalud

Palencia, Spain

Location

Residencia CleceVitam San Antonio

Salamanca, Spain

Location

CleceVitam Gerohotel

Valladolid, Spain

Location

Residencia León Trucíos

Vizcaya, Spain

Location

Related Publications (34)

• 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.

  PMID: 21450215 BACKGROUND

• 2021 Alzheimer's disease facts and figures. Alzheimers Dement. 2021 Mar;17(3):327-406. doi: 10.1002/alz.12328. Epub 2021 Mar 23.

  PMID: 33756057 BACKGROUND

• 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.

  PMID: 36471336 BACKGROUND

• 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.

  PMID: 2715584 BACKGROUND

• 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.

  PMID: 24595028 BACKGROUND

• 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.

  PMID: 29767329 BACKGROUND

• 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.

  PMID: 31668459 BACKGROUND

• 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.

  PMID: 12021425 BACKGROUND

• 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.

  PMID: 18297476 BACKGROUND

• 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.

  PMID: 29165558 BACKGROUND

• 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.

  PMID: 21320303 BACKGROUND

• 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.

  PMID: 23963293 BACKGROUND

• 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.

  PMID: 31738463 BACKGROUND

• 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.

  PMID: 32674372 BACKGROUND

• 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.

  PMID: 34041803 BACKGROUND

• 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.

  PMID: 20639620 BACKGROUND

• 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.

  PMID: 7183759 BACKGROUND

• 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.

  PMID: 35462001 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Glick HA, Doshi JA, Sonnad SS, Polsky D. Economic evaluation in clinical trials. 1st. ed. Oxford: Oxford University Press; 2007.

  BACKGROUND

• 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.

  PMID: 21570161 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 15691450 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 20838046 BACKGROUND

• Plan integral de Alzheimer y otras demencias (2019-2023). Madrid: Ministerio de Sanidad, Consumo y Bienestar Social; 2019.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Dementia; Neurocognitive Disorders; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Cognition Disorders

Study Officials

• Enrique Perez, Phd

  Centro de Referencia Estatal de atención a personas con enfermedad de Alzheimer y otras demencias - Imserso

  STUDY DIRECTOR

• Teresa Rodriguez, MSc

  Centro de Referencia Estatal de atención a personas con enfermedad de Alzheimer y otras demencias - Imserso

  PRINCIPAL INVESTIGATOR

• Mireia Tofiño, MSc

  Centro de Referencia Estatal de atención a personas con enfermedad de Alzheimer y otras demencias - Imserso

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The technician in charge of assessing users participating in the study must be blinded throughout the intervention, i.e., he/she will not be able to know whether the assessed users belong to the experimental group or to the control group. 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neuropsychologist

Model Details: The investigators propose the conduct of a randomized and controlled multicenter pragmatic clinical trial to compare 12 weeks of robot therapy sessions with the PARO robot versus 12 weeks of standard care. Participants who meet the inclusion criteria will be allocated by block randomization to either the PARO robot intervention group or the standard care control group. Participants allocated to the PARO group will undergo three intervention sessions per week for 12 weeks, in addition to continuing their standard care. Participants in the control group will maintain their standard care, participating in those activities previously assigned in their individual care plan. In addition, follow-up will be performed 12 weeks after the end of the intervention to assess the duration of the effects.

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: June 1, 2023
• Study Start: April 10, 2023
• Primary Completion: October 6, 2023
• Study Completion: October 6, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (15)