Clinical trial NCT05884424: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Neurocognitive Disorders
Mild Cognitive Impairment
Keywords: Dementia
Neurocognitive Disorders
Mild Cognitive Impairment
Robot therapy
Quality of life
Neuropsychiatric symptoms
Older adult
Robot
Cost-effectiveness
Lead sponsor: Instituto de Mayores y Servicios Sociales (IMSERSO)
Sponsor class: OTHER_GOV
Collaborators: name: Asturhealth SL
name: Servicio de Evaluación y Planificación del Servicio Canario de la Salud (SESCS)
First posted: 2023-06-01
Enrollment: 123
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD)
timeFrame: Baseline (T0)
measure: Change in quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD)
timeFrame: 12 weeks after the beginning of the intervention (T1)
measure: Change in quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD)
timeFrame: 12 weeks after end of the intervention (T2)
measure: Quality of life evaluated through EQ-5D-5L
timeFrame: Baseline (T0)
measure: Change in quality of life evaluated through EQ-5D-5L
timeFrame: 12 weeks after the beginning of the intervention (T1)
measure: Change in quality of life evaluated through EQ-5D-5L
timeFrame: 12 weeks after end of the intervention (T2)
Secondary outcomes:
measure: Mood assessed through the Geriatric Depression Scale-15 (GDS-15)
timeFrame: Baseline (T0)
measure: Change in mood assessed through the Geriatric Depression Scale-15 (GDS-15)
timeFrame: 12 weeks after the beginning of the intervention (T1)
measure: Change in mood assessed through the Geriatric Depression Scale-15 (GDS-15)
timeFrame: 12 weeks after end of the intervention (T2)
measure: Apathy assessed through the Apathy in Dementia-Nursing Home (APADEM-NH)
timeFrame: Baseline (T0)
measure: Change in apathy assessed through the Apathy in Dementia-Nursing Home (APADEM-NH)
timeFrame: 12 weeks after the beginning of the intervention (T1)
measure: Change in apathy assessed through the Apathy in Dementia-Nursing Home (APADEM-NH)
timeFrame: 12 weeks after end of the intervention (T2)
measure: Agitation assessed through the Cohen-Mansfield Agitation Inventory (CMAI)
timeFrame: Baseline (T0)
measure: Change in agitation assessed through the Cohen-Mansfield Agitation Inventory (CMAI)
timeFrame: 12 weeks after the beginning of the intervention (T1)
measure: Change in agitation assessed through the Cohen-Mansfield Agitation Inventory (CMAI)
timeFrame: 12 weeks after end of the intervention (T2)
Other outcomes:
measure: Psychotropic medication
timeFrame: Baseline (T0)
measure: Change in psychotropic medication
timeFrame: 12 weeks after the beginning of the intervention (T1)
measure: Rescue medication
timeFrame: 12 weeks after the beginning of the intervention (T1)
measure: Cost-Effectiveness
timeFrame: 12 weeks after the beginning of the intervention (T1)
measure: Acceptability of PARO robot
timeFrame: Post-intervention (T1) (after 12 weeks of robot therapy intervention)
Locations:
city: Vigo
country: Spain
facility: ATENDO Calidade S.L
state: Pontevedra
city: Alicante
country: Spain
facility: Residencia DomusVi Alcoi
city: Alicante
country: Spain
facility: Residencia DomusVi Alicante Babel
city: Burgos
country: Spain
facility: Residencia CleceVitam San Pedro Poveda
city: Castelló
country: Spain
facility: Residencia DomusVi Vila-Real
city: La Coruña
country: Spain
facility: Centro Residencial CleceVitam Bastiagueiro
city: Lérida
country: Spain
facility: Residencia CleceVitam Ponent
city: Madrid
country: Spain
facility: Residencia de Mayores Albertia Moratalaz
city: Madrid
country: Spain
facility: Residencia ORPEA Madrid Buenavista
city: Madrid
country: Spain
facility: Residencia ORPEA Pinto
city: Murcia
country: Spain
facility: Centro Residencial CleceVitam Carmen Conde
city: Palencia
country: Spain
facility: Residencia Bañosalud
city: Salamanca
country: Spain
facility: Residencia CleceVitam San Antonio
city: Valladolid
country: Spain
facility: CleceVitam Gerohotel
city: Vizcaya
country: Spain
facility: Residencia León Trucíos
Study officials:
affiliation: Centro de Referencia Estatal de atención a personas con enfermedad de Alzheimer y otras demencias - Imserso
name: Enrique Perez, Phd
role: STUDY_DIRECTOR
affiliation: Centro de Referencia Estatal de atención a personas con enfermedad de Alzheimer y otras demencias - Imserso
name: Teresa Rodriguez, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro de Referencia Estatal de atención a personas con enfermedad de Alzheimer y otras demencias - Imserso
name: Mireia Tofiño, MSc
role: PRINCIPAL_INVESTIGATOR
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