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

Primary Purpose

Dementia, Neurocognitive Disorders, Mild Cognitive Impairment

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
PARO Therapy Robot
Sponsored by
Instituto de Mayores y Servicios Sociales (IMSERSO)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia focused on measuring Dementia, Neurocognitive Disorders, Mild Cognitive Impairment, Robot therapy, Quality of life, Neuropsychiatric symptoms, Older adult, Robot, Cost-effectiveness

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • ATENDO Calidade S.L
  • Residencia DomusVi Alcoi
  • Residencia DomusVi Alicante Babel
  • Residencia CleceVitam San Pedro Poveda
  • Residencia DomusVi Vila-Real
  • Centro Residencial CleceVitam Bastiagueiro
  • Residencia CleceVitam Ponent
  • Residencia de Mayores Albertia Moratalaz
  • Residencia ORPEA Madrid Buenavista
  • Residencia ORPEA Pinto
  • Centro Residencial CleceVitam Carmen Conde
  • Residencia Bañosalud
  • Residencia CleceVitam San Antonio
  • CleceVitam Gerohotel
  • Residencia León Trucíos

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PARO Therapy Robot

Control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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).
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).
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).

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
April 14, 2023
Last Updated
May 22, 2023
Sponsor
Instituto de Mayores y Servicios Sociales (IMSERSO)
Collaborators
Asturhealth SL, Servicio de Evaluación y Planificación del Servicio Canario de la Salud (SESCS)
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1. Study Identification

Unique Protocol Identification Number
NCT05884424
Brief Title
Effectiveness and Cost-Effectiveness of Robot Therapy With the Paro Robot in People Living With Dementia
Official Title
Effectiveness and Cost-Effectiveness of Robot Therapy With the Paro Robot in People Living With Dementia: A Randomized Controlled Multicenter Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 10, 2023 (Actual)
Primary Completion Date
October 6, 2023 (Anticipated)
Study Completion Date
October 6, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto de Mayores y Servicios Sociales (IMSERSO)
Collaborators
Asturhealth SL, Servicio de Evaluación y Planificación del Servicio Canario de la Salud (SESCS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PARO Therapy Robot
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants in the control group will maintain their standard care, participating in those activities previously assigned in their individual care plan.
Intervention Type
Behavioral
Intervention Name(s)
PARO Therapy Robot
Other Intervention Name(s)
PARO
Intervention Description
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).
Primary Outcome Measure Information:
Title
Quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD)
Description
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.
Time Frame
Baseline (T0)
Title
Change in quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD)
Description
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.
Time Frame
12 weeks after the beginning of the intervention (T1)
Title
Change in quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD)
Description
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.
Time Frame
12 weeks after end of the intervention (T2)
Title
Quality of life evaluated through EQ-5D-5L
Description
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).
Time Frame
Baseline (T0)
Title
Change in quality of life evaluated through EQ-5D-5L
Description
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).
Time Frame
12 weeks after the beginning of the intervention (T1)
Title
Change in quality of life evaluated through EQ-5D-5L
Description
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).
Time Frame
12 weeks after end of the intervention (T2)
Secondary Outcome Measure Information:
Title
Mood assessed through the Geriatric Depression Scale-15 (GDS-15)
Description
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.
Time Frame
Baseline (T0)
Title
Change in mood assessed through the Geriatric Depression Scale-15 (GDS-15)
Description
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.
Time Frame
12 weeks after the beginning of the intervention (T1)
Title
Change in mood assessed through the Geriatric Depression Scale-15 (GDS-15)
Description
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.
Time Frame
12 weeks after end of the intervention (T2)
Title
Apathy assessed through the Apathy in Dementia-Nursing Home (APADEM-NH)
Description
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.
Time Frame
Baseline (T0)
Title
Change in apathy assessed through the Apathy in Dementia-Nursing Home (APADEM-NH)
Description
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.
Time Frame
12 weeks after the beginning of the intervention (T1)
Title
Change in apathy assessed through the Apathy in Dementia-Nursing Home (APADEM-NH)
Description
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.
Time Frame
12 weeks after end of the intervention (T2)
Title
Agitation assessed through the Cohen-Mansfield Agitation Inventory (CMAI)
Description
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.
Time Frame
Baseline (T0)
Title
Change in agitation assessed through the Cohen-Mansfield Agitation Inventory (CMAI)
Description
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.
Time Frame
12 weeks after the beginning of the intervention (T1)
Title
Change in agitation assessed through the Cohen-Mansfield Agitation Inventory (CMAI)
Description
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.
Time Frame
12 weeks after end of the intervention (T2)
Other Pre-specified Outcome Measures:
Title
Psychotropic medication
Description
Psychotropic medication (antidementia drugs, antidepressants, anxiolytics and antipsychotics) prescribed at baseline (T0)
Time Frame
Baseline (T0)
Title
Change in psychotropic medication
Description
Change in psychotropic medication (antidementia drugs, antidepressants, anxiolytics and antipsychotics) prescribed between baseline (T0) and after the intervention (T1).
Time Frame
12 weeks after the beginning of the intervention (T1)
Title
Rescue medication
Description
Number of rescue medication doses used by each participant during the study period
Time Frame
12 weeks after the beginning of the intervention (T1)
Title
Cost-Effectiveness
Description
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.
Time Frame
12 weeks after the beginning of the intervention (T1)
Title
Acceptability of PARO robot
Description
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.
Time Frame
Post-intervention (T1) (after 12 weeks of robot therapy intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enrique Perez, Phd
Organizational Affiliation
Centro de Referencia Estatal de atención a personas con enfermedad de Alzheimer y otras demencias - Imserso
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Teresa Rodriguez, MSc
Organizational Affiliation
Centro de Referencia Estatal de atención a personas con enfermedad de Alzheimer y otras demencias - Imserso
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mireia Tofiño, MSc
Organizational Affiliation
Centro de Referencia Estatal de atención a personas con enfermedad de Alzheimer y otras demencias - Imserso
Official's Role
Principal Investigator
Facility Information:
Facility Name
ATENDO Calidade S.L
City
Vigo
State/Province
Pontevedra
Country
Spain
Facility Name
Residencia DomusVi Alcoi
City
Alicante
Country
Spain
Facility Name
Residencia DomusVi Alicante Babel
City
Alicante
Country
Spain
Facility Name
Residencia CleceVitam San Pedro Poveda
City
Burgos
Country
Spain
Facility Name
Residencia DomusVi Vila-Real
City
Castelló
Country
Spain
Facility Name
Centro Residencial CleceVitam Bastiagueiro
City
La Coruña
Country
Spain
Facility Name
Residencia CleceVitam Ponent
City
Lérida
Country
Spain
Facility Name
Residencia de Mayores Albertia Moratalaz
City
Madrid
ZIP/Postal Code
28030
Country
Spain
Facility Name
Residencia ORPEA Madrid Buenavista
City
Madrid
Country
Spain
Facility Name
Residencia ORPEA Pinto
City
Madrid
Country
Spain
Facility Name
Centro Residencial CleceVitam Carmen Conde
City
Murcia
Country
Spain
Facility Name
Residencia Bañosalud
City
Palencia
Country
Spain
Facility Name
Residencia CleceVitam San Antonio
City
Salamanca
Country
Spain
Facility Name
CleceVitam Gerohotel
City
Valladolid
Country
Spain
Facility Name
Residencia León Trucíos
City
Vizcaya
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
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Effectiveness and Cost-Effectiveness of Robot Therapy With the Paro Robot in People Living With Dementia

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