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

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05884424
• Other study ID #: 04/22
• Status: Completed
• Phase: N/A
• Start date: April 10, 2023
• Est. completion date: October 6, 2023

Study information

• Verified date: November 2023
• Source: Instituto de Mayores y Servicios Sociales (IMSERSO)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: October 6, 2023
• Est. primary completion date: October 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Dementia
• Mild Cognitive Impairment
• Neurocognitive Disorders

Intervention

Behavioral:
• PARO Therapy Robot
Participants allocated to the PARO Therapy Robot group will receive three group robot therapy sessions per week for 12 weeks, in addition to continuing their standard care. Robot therapy session will last 20 minutes. The sessions will be partially guided, intending to allow participants to interact with the robot seal freely for as long as possible, but redirecting the activity if necessary. The sessions will be conducted in group format, in groups of 4 users, with participants sitting in a circle around a table. The professional conducting the sessions will be a therapist with experience in NPT for people living with dementia, and who has attended the training session on the study intervention protocol. The sessions will be structured as follows: 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).

Locations

Country	Name	City	State
Spain	Residencia DomusVi Alcoi	Alicante
Spain	Residencia DomusVi Alicante Babel	Alicante
Spain	Residencia CleceVitam San Pedro Poveda	Burgos
Spain	Residencia DomusVi Vila-Real	Castelló
Spain	Centro Residencial CleceVitam Bastiagueiro	La Coruña
Spain	Residencia CleceVitam Ponent	Lérida
Spain	Residencia de Mayores Albertia Moratalaz	Madrid
Spain	Residencia ORPEA Madrid Buenavista	Madrid
Spain	Residencia ORPEA Pinto	Madrid
Spain	Centro Residencial CleceVitam Carmen Conde	Murcia
Spain	Residencia Bañosalud	Palencia
Spain	Residencia CleceVitam San Antonio	Salamanca
Spain	CleceVitam Gerohotel	Valladolid
Spain	ATENDO Calidade S.L	Vigo	Pontevedra
Spain	Residencia León Trucíos	Vizcaya

Sponsors (3)

Lead Sponsor	Collaborator
Instituto de Mayores y Servicios Sociales (IMSERSO)	Asturhealth SL, Servicio de Evaluación y Planificación del Servicio Canario de la Salud (SESCS)

Country where clinical trial is conducted

Spain, 

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Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Psychotropic medication	Psychotropic medication (antidementia drugs, antidepressants, anxiolytics and antipsychotics) prescribed at baseline (T0)	Baseline (T0)
Other	Change in psychotropic medication	Change in psychotropic medication (antidementia drugs, antidepressants, anxiolytics and antipsychotics) prescribed between baseline (T0) and after the intervention (T1).	12 weeks after the beginning of the intervention (T1)
Other	Rescue medication	Number of rescue medication doses used by each participant during the study period	12 weeks after the beginning of the intervention (T1)
Other	Cost-Effectiveness	The cost-effectiveness measure will be the incremental cost-effectiveness ratio (ICER), obtained by dividing the difference between the cost of the PARO Therapy Robot intervention and the standard care by the difference in effectiveness (quality-adjusted life-years [QALY]) between the PARO Therapy Robot intervention and the standard care.	12 weeks after the beginning of the intervention (T1)
Other	Acceptability of PARO robot	The technicians who have performed the intervention will complete a questionnaire to assess the acceptability of PARO with each user who has participated. The questionnaire comprises 7 items that assess the participants from the perspective of the therapists. The questionnaire to be used encompasses several aspects such as closeness to the robot, feeling of well-being during the interaction, practicality, and actions of rejection. Each item is scored on a Likert-type scale from 1-5, where 1 = totally disagree and 5 = totally agree.	Post-intervention (T1) (after 12 weeks of robot therapy intervention)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)