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

Instituto de Mayores y Servicios Sociales (IMSERSO)

Status: Completed

Conditions: Mild Cognitive Impairment; Neurocognitive Disorders; Dementia

Treatments: Behavioral: PARO Therapy Robot

Study type: Interventional

Funder types: Other

Identifiers

NCT05884424

04/22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 123 patients

Sex: All

Ages: 60+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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123 participants in 2 patient groups

PARO Therapy Robot

Experimental group

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.

Treatment:

Behavioral: PARO Therapy Robot

Control

No Intervention group

Description:

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