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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness and Cost-Effectiveness of Robot Therapy With the Paro Robot in People Living With Dementia: A Randomized Controlled Multicenter Clinical Trial

Conditions
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Dementia, Neurocognitive Disorders, Mild Cognitive Impairment

Intervention / Treatment
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* Behavioral: PARO Therapy Robot


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Presence of sensory limitations that preclude participation in the sessions. Health issues that advise against or impede participation in the sessions.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PARO Therapy Robot<br>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<br>* 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).<br>* Other names: PARO;|
| No Intervention: Control<br>Participants in the control group will maintain their standard care, participating in those activities previously assigned in their individual care plan. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 12 weeks after end of the intervention (T2) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dementia, Neurocognitive Disorders, Mild Cognitive Impairment, Robot therapy, Quality of life, Neuropsychiatric symptoms, Older adult, Robot, Cost-effectiveness