DementiaNCT05884424
Effectiveness and Cost-Effectiveness of Robot Therapy With the Paro Robot in People Living With Dementia
A study testing PARO Therapy Robot in people with Dementia and Neurocognitive Disorders, run by Instituto de Mayores y Servicios Sociales (IMSERSO) at 15 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dementia, Neurocognitive Disorders, Mild Cognitive Impairment
- What is being tested?
- PARO Therapy Robot
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 15 sitesSpain
- Study dates
- 10 Apr 2023to 6 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Presence of sensory limitations that preclude participation in the sessions.
- Health issues that advise against or impede participation in the sessions.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Spain15 sites
Centro Residencial CleceVitam Bastiagueiro
A Coruña
Residencia DomusVi Alcoi
Alicante
Residencia DomusVi Alicante Babel
Alicante
Residencia CleceVitam San Pedro Poveda
Burgos
Residencia DomusVi Vila-Real
Castelló
Residencia CleceVitam Ponent
Lleida
Residencia de Mayores Albertia Moratalaz
Madrid, 28030
Residencia ORPEA Madrid Buenavista
Madrid
Residencia ORPEA Pinto
Madrid
Centro Residencial CleceVitam Carmen Conde
Murcia
Residencia Bañosalud
Palencia
Residencia CleceVitam San Antonio
Salamanca
CleceVitam Gerohotel
Valladolid
ATENDO Calidade S.L
Vigo, Pontevedra
Residencia León Trucíos
Vizcaya
About this study
Official title: Effectiveness and Cost-Effectiveness of Robot Therapy With the Paro Robot in People Living With Dementia: A Randomized Controlled Multicenter Clinical Trial
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.
Read the detailed description
The increase in life expectancy in recent decades has been associated with inevitable aging of the population and a rise in the prevalence of dementia. The World Health Organization (WHO) defines dementia as an acquired condition involving multiple cognitive disabilities that are sufficient to interfere with the daily life of the patients and their environment, with important associated personal suffering and economic costs. Despite advances in recent years, the diagnosis and course of dementia remains a challenge for professionals, and there continue to be important social and healthcare shortcomings regarding prevention, treatment and care.
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.
- Being tested
- PARO Therapy Robot
- Keywords
- Dementia, Neurocognitive Disorders, Mild Cognitive Impairment, Robot therapy, Quality of life, Neuropsychiatric symptoms, Older adult, Robot, Cost-effectiveness
- Medical subject headings
- Dementia, Neurocognitive Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PARO Therapy RobotBehavioural
Also called PARO
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:
- Welcome and presentation.
- Main activity with PARO.
- PARO cleaning.
- 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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 12 weeks after end of the intervention (T2)
Secondary outcomes (9)
Mood assessed through the Geriatric Depression Scale-15 (GDS-15)
Geriatric Depression Scale (GDS-15). GDS-15 consists of 15 yes/no questions and the score ranges from 0-15. Scores of 6 or higher on a maximum of 15 points are considered to be indicative of depression. The Spanish adaptation of this scale will be used. This scale is administered to the person with dementia.
Measured: Baseline (T0)
Change in mood assessed through the Geriatric Depression Scale-15 (GDS-15)
Geriatric Depression Scale (GDS-15). GDS-15 consists of 15 yes/no questions and the score ranges from 0-15. Scores of 6 or higher on a maximum of 15 points are considered to be indicative of depression. The Spanish adaptation of this scale will be used. This scale is administered to the person with dementia.
Measured: 12 weeks after the beginning of the intervention (T1)
Change in mood assessed through the Geriatric Depression Scale-15 (GDS-15)
Geriatric Depression Scale (GDS-15). GDS-15 consists of 15 yes/no questions and the score ranges from 0-15. Scores of 6 or higher on a maximum of 15 points are considered to be indicative of depression. The Spanish adaptation of this scale will be used. This scale is administered to the person with dementia.
Measured: 12 weeks after end of the intervention (T2)
Apathy assessed through the Apathy in Dementia-Nursing Home (APADEM-NH)
APADEM-NH explores the dimensions of thought deficit (33 items), emotional blunting (17 items), and cognitive inertia (16 items), based on a Likert-type scale from 0 (no apathy) to 3 (severe apathy). This scale will be completed by a regular caregiver of the person with dementia, who in this case will be a professional at the site.
Measured: Baseline (T0)
Change in apathy assessed through the Apathy in Dementia-Nursing Home (APADEM-NH)
APADEM-NH explores the dimensions of thought deficit (33 items), emotional blunting (17 items), and cognitive inertia (16 items), based on a Likert-type scale from 0 (no apathy) to 3 (severe apathy). This scale will be completed by a regular caregiver of the person with dementia, who in this case will be a professional at the site.
Measured: 12 weeks after the beginning of the intervention (T1)
Change in apathy assessed through the Apathy in Dementia-Nursing Home (APADEM-NH)
APADEM-NH explores the dimensions of thought deficit (33 items), emotional blunting (17 items), and cognitive inertia (16 items), based on a Likert-type scale from 0 (no apathy) to 3 (severe apathy). This scale will be completed by a regular caregiver of the person with dementia, who in this case will be a professional at the site.
Measured: 12 weeks after end of the intervention (T2)
Agitation assessed through the Cohen-Mansfield Agitation Inventory (CMAI)
Cohen-Mansfield Agitation Inventory (CMAI). CMAI is a tool developed for the detection and assessment of agitation behavior in elderly people. The adaptation to Spanish of this tool is the Cohen-Mansfield Agitation Inventory of the elderly. In the same way as the APADEM-NH, this scale will be completed by a professional at the site who frequently works in the care of the user.
Measured: Baseline (T0)
Change in agitation assessed through the Cohen-Mansfield Agitation Inventory (CMAI)
Cohen-Mansfield Agitation Inventory (CMAI). CMAI is a tool developed for the detection and assessment of agitation behavior in elderly people. The adaptation to Spanish of this tool is the Cohen-Mansfield Agitation Inventory of the elderly. In the same way as the APADEM-NH, this scale will be completed by a professional at the site who frequently works in the care of the user.
Measured: 12 weeks after the beginning of the intervention (T1)
Change in agitation assessed through the Cohen-Mansfield Agitation Inventory (CMAI)
Cohen-Mansfield Agitation Inventory (CMAI). CMAI is a tool developed for the detection and assessment of agitation behavior in elderly people. The adaptation to Spanish of this tool is the Cohen-Mansfield Agitation Inventory of the elderly. In the same way as the APADEM-NH, this scale will be completed by a professional at the site who frequently works in the care of the user.
Measured: 12 weeks after end of the intervention (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start10 Apr 2023
- Primary completion6 Oct 2023
- Study completion6 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Mayores y Servicios Sociales (IMSERSO)
- Sponsor type
- Other government
- Collaborators
- Asturhealth SL, Servicio Canario de Salud
- Responsible party
- Principal investigator, Enrique Perez Saez, Instituto de Mayores y Servicios Sociales (IMSERSO)
- Investigators
- Enrique Perez, Phd, Study director, Centro de Referencia Estatal de atención a personas con enfermedad de Alzheimer y otras demencias - ImsersoTeresa Rodriguez, MSc, Principal investigator, Centro de Referencia Estatal de atención a personas con enfermedad de Alzheimer y otras demencias - ImsersoMireia Tofiño, MSc, Principal investigator, Centro de Referencia Estatal de atención a personas con enfermedad de Alzheimer y otras demencias - Imserso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884424
- Sponsor's protocol ID
- 04/22
- Status last verified
- Nov 2023
- First submitted
- 14 Apr 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 214502152021 Alzheimer's disease facts and figures. Alzheimers Dement. 2021 Mar;17(3):327-406. doi: 10.1002/alz.12328. Epub 2021 Mar 23.
PubMed 33756057Asl 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.
PubMed 36471336Cohen-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.
PubMed 2715584Frings 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.
PubMed 24595028Hernandez 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.
PubMed 29767329Kang 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.
PubMed 31668459Logsdon 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.
PubMed 12021425Moniz-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.
PubMed 18297476Moyle 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.
PubMed 29165558O'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.
PubMed 21320303Peters 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.
PubMed 23963293Pu 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.
PubMed 31738463Martin 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.
PubMed 32674372Saragih 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.
PubMed 34041803
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Cost-Effectiveness of Robot Therapy With the Paro Robot in People Living With Dementia: A Randomized Controlled Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT05884424
- Acronym / sponsor ID
- 04/22
- Keywords
- Dementia, Neurocognitive Disorders, Mild Cognitive Impairment, Robot therapy, Quality of life, Neuropsychiatric symptoms, Older adult, Robot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Instituto de Mayores y Servicios Sociales (IMSERSO)Other government
- Collaborators
- Asturhealth SL, Servicio Canario de Salud
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 6 Oct 2023 (actual)
- Study completion
- 6 Oct 2023 (actual)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The increase in life expectancy in recent decades has been associated with inevitable aging of the population and a rise in the prevalence of dementia. The World Health Organization (WHO) defines dementia as an acquired condition involving multiple cognitive disabilities that are sufficient to interfere with the daily life of the patients and their environment, with important associated personal suffering and economic costs. Despite advances in recent years, the diagnosis and course of dementia remains a challenge for professionals, and there continue to be important social and healthcare shortcomings regarding prevention, treatment and care.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| PARO Therapy Robot | Experimental | Behavioral: PARO Therapy RobotParticipants 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. |
| Control | No intervention | –Participants in the control group will maintain their standard care, participating in those activities previously assigned in their individual care plan. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Presence of sensory limitations that preclude participation in the sessions.
- Health issues that advise against or impede participation in the sessions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PARO Therapy RobotAlso: PAROParticipants 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). | Behavioural | PARO Therapy Robot |
Primary outcome
Quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD)
Time frame: Baseline (T0)
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.
Change in quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD)
Time frame: 12 weeks after the beginning of the intervention (T1)
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.
Change in quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD)
Time frame: 12 weeks after end of the intervention (T2)
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.
Quality of life evaluated through EQ-5D-5L
Time frame: Baseline (T0)
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).
Change in quality of life evaluated through EQ-5D-5L
Time frame: 12 weeks after the beginning of the intervention (T1)
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).
Change in quality of life evaluated through EQ-5D-5L
Time frame: 12 weeks after end of the intervention (T2)
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).
9 secondary outcomes
Mood assessed through the Geriatric Depression Scale-15 (GDS-15)
Time frame: Baseline (T0)
Change in mood assessed through the Geriatric Depression Scale-15 (GDS-15)
Time frame: 12 weeks after the beginning of the intervention (T1)
Change in mood assessed through the Geriatric Depression Scale-15 (GDS-15)
Time frame: 12 weeks after end of the intervention (T2)
Apathy assessed through the Apathy in Dementia-Nursing Home (APADEM-NH)
Time frame: Baseline (T0)
Change in apathy assessed through the Apathy in Dementia-Nursing Home (APADEM-NH)
Time frame: 12 weeks after the beginning of the intervention (T1)
Change in apathy assessed through the Apathy in Dementia-Nursing Home (APADEM-NH)
Time frame: 12 weeks after end of the intervention (T2)
Agitation assessed through the Cohen-Mansfield Agitation Inventory (CMAI)
Time frame: Baseline (T0)
Change in agitation assessed through the Cohen-Mansfield Agitation Inventory (CMAI)
Time frame: 12 weeks after the beginning of the intervention (T1)
Change in agitation assessed through the Cohen-Mansfield Agitation Inventory (CMAI)
Time frame: 12 weeks after end of the intervention (T2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Background: PubMed 21450215Bemelmans 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.
- Background: PubMed 337560572021 Alzheimer's disease facts and figures. Alzheimers Dement. 2021 Mar;17(3):327-406. doi: 10.1002/alz.12328. Epub 2021 Mar 23.
- Background: PubMed 36471336Asl 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.
- Background: PubMed 2715584Cohen-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.
- Background: PubMed 24595028Frings 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.
- Background: PubMed 29767329Hernandez 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.
- Background: PubMed 31668459Kang 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.
- Background: PubMed 12021425Logsdon 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.
- Background: PubMed 18297476Moniz-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.
- Background: PubMed 29165558Moyle 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.
- Background: PubMed 21320303O'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.
- Background: PubMed 23963293Peters 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enrique Perez, Phd study director
Centro de Referencia Estatal de atención a personas con enfermedad de Alzheimer y otras demencias - Imserso
Teresa Rodriguez, MSc principal investigator
Centro de Referencia Estatal de atención a personas con enfermedad de Alzheimer y otras demencias - Imserso
Mireia Tofiño, MSc principal investigator
Centro de Referencia Estatal de atención a personas con enfermedad de Alzheimer y otras demencias - Imserso
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PARO Therapy Robot in people with Dementia and Neurocognitive Disorders, run by Instituto de Mayores y Servicios Sociales (IMSERSO) at 15 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD) (time frame: Baseline (T0)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05884424, which also lists 34 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.