Effects of a Socially Assistive Robot Coach on Physical and Psychosocial Outcomes of Caregivers, Dementia Trainers and Persons With Dementia Living at Home: a Mixed Method Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Change of motivation (persons with dementia)
研究概览
简要总结
Background:
Dementia rates are increasing worldwide and consequently burden global healthcare resources to a serious degree. However, there is a declining number of caregivers to provide care. It is for this reason that many new technologies, such as socially assistive robots, have been developed because of their potential to support caregivers in promoting the independence of people with dementia.
Most of the (socially assistive) robots have so far been tested for people without dementia in mainly laboratory or in institutional settings, like nursing homes. Consequently, there is a lack of knowledge about the possible uses of robots from the perspective of those affected by dementia in real-life/care situations (e.g. at home). Testing in a laboratory setting cannot capture the complexity and high variability of everyday situations occurring during the care of persons with dementia.
Aim:
The aim is to investigate the effect of a socially assistive humanoid robot on the physical and psychosocial outcomes of caregivers, dementia trainers and persons with dementia living at home.
Methods:
The design is a mixed method randomized clinical trial. As an intervention, 20 persons with dementia and their relatives will receive a socially assistive humanoid robot coach (including a theratainment app for physical and cognitive exercises). The control group (also 20 persons with dementia and their relatives) will receive a tablet including the same theratainment app as in the intervention group, but without the robot.
Data will be collected using sensor data of the robot and the tablet, eye tracking, questionnaires, observation and interviews. There are also questionnaires for the relatives (n=40), dementia trainers (n=5) and professional caregivers (n=5).
Data analysis is quantitative (descriptive statistics, median regression, covariance analysis, wilcoxon rank-sum test) and qualitative (content analysis).
The planned study supports the further development of socially assistive robots with regard to the individual needs of persons with dementia living at home.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Masking is not possible, because of the used interventions
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persons with dementia:
- •living at home
- •all types of dementia (except frontotemporal dementia)
- •light and moderate dementia (MMSE 10 and above)
- •light dementia: living alone or with relative at home (if alone: the relative should live in the neighborhood and be in daily contact with the person with dementia)
- •moderate dementia: living with a relative at home
- •receive professional and/or non-professional care or no care
- •speak and understand German
- •have no physical, auditory or visual restrictions, which would make the application of the interventions impossible.
- •do not take any dementia-specific medication or have been taking dementia-specific medication for at least 3 months; condition stable and no change expected during the study period
- •do not take antipsychotics and antidepressants or have been taking them for at least 14 days before study start
- •children and pets in the household after previous individual discussion
- •relatives of the participating persons with dementia (adults)
- •relatives means family members, like spouse, daughter, aunt, ... or significant others like friends and neighbors
- •living or not living with the person with dementia in the same household (in the case of moderate dementia, relatives must live in the same household)
- •person with dementia receives or receives no professional care
- •relative provides or does not provide care
- •if the persons with dementia receive paid 24-hour care (regardless of whether they have mild or moderate dementia), a relative still has to be recruited as a participant (this relative must live in the same house or household and be in daily contact with the person with dementia)
- •speak and understand German
- •Professional caregivers
- •nurses or nursing assistants
- •speak and understand German
- •Dementia trainers
- •trained as M.A.S. (Morbus Alzheimer Syndrome) trainer
- •train the participants with dementia at home
- •speak and understand German
排除标准
- •Persons with dementia:
- •frontotemporal dementia
- •known aggressive behavior
研究组 & 干预措施
Coach Pepper group
Pepper is a humanoid socially assistive robot.
干预措施: Coach Pepper group (Device)
Tablet group
Tablet training
干预措施: Tablet group (Device)
结局指标
主要结局
Change of motivation (persons with dementia)
时间窗: 3 weeks
The "Apathy Evaluation Scale" is a scale to measure motivation because apathy can be understood as a loss of motivation. The scale has 18 items (4-point Likert scale). 18-72 points can be obtained. Higher scores correspond to a higher degree of apathy and therefore lower motivation. Furthermore, sensor data of the robot Pepper/ the tablet will be analysed (usage of different functions).
Change of care burden (relatives)
时间窗: 3 weeks
The "Zarid Burden Interview" captures the subjective burden of caregivers. The instrument has 22 items (5-point Likert scale). 0 - 88 points can be obtained. Higher scores indicate greater caregiver distress.
次要结局
- Technology acceptance (persons with dementia, relatives, dementia trainers, professional caregivers)(3 weeks)
- Change of quality of life (persons with dementia, relatives): The "Dementia Quality of Life Instrument"(3 weeks)
- Change of care dependency (persons with dementia)(3 weeks)
- Change of cognition (persons with dementia)(3 weeks)
- Change of depression (persons with dementia, relatives)(3 weeks)
- Change of usability/acceptance (persons with dementia): semi-structured observation(3 weeks)
- Change of affect (relatives)(3 weeks)
- Change of behavioral problems (persons with dementia)(3 weeks)
- Change of mobility (persons with dementia)(3 weeks)
研究者
Sandra Schüssler
Deputy Head of the Institute of Nursing Science
Medical University of Graz