Effectiveness and Cost-Effectiveness of Robot Therapy With the Paro Robot in People Living With Dementia: A Randomized Controlled Multicenter Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 123
- 试验地点
- 16
- 主要终点
- Quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Presence of sensory limitations that preclude participation in the sessions.
- •Health issues that advise against or impede participation in the sessions.
结局指标
主要结局
Quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD)
时间窗: Baseline (T0)
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)
时间窗: 12 weeks after end of the intervention (T2)
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
时间窗: Baseline (T0)
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
时间窗: 12 weeks after end of the intervention (T2)
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).
次要结局
- Change in mood assessed through the Geriatric Depression Scale-15 (GDS-15)(12 weeks after end of the intervention (T2))
- Apathy assessed through the Apathy in Dementia-Nursing Home (APADEM-NH)(Baseline (T0))
- Change in apathy assessed through the Apathy in Dementia-Nursing Home (APADEM-NH)(12 weeks after end of the intervention (T2))
- Mood assessed through the Geriatric Depression Scale-15 (GDS-15)(Baseline (T0))
- Agitation assessed through the Cohen-Mansfield Agitation Inventory (CMAI)(Baseline (T0))
- Change in agitation assessed through the Cohen-Mansfield Agitation Inventory (CMAI)(12 weeks after end of the intervention (T2))
研究者
Enrique Perez Saez
Neuropsychologist
Instituto de Mayores y Servicios Sociales (IMSERSO)