Clinical trial NCT03818217: Effects of a Robot on Physical and Psychosocial Outcomes of Persons With Dementia and Their Social Environment at Home
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: socially assistive robot
humanoid robot
motivation
home care
cognitive training
physical training
caregivers
dementia trainers
Computers, handheld
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: Joanneum Research Forschungsgesellschaft mbH
name: Sozialverein Deutschlandsberg
name: Humanizing Technologies GmbH
First posted: 2019-01-28
Enrollment: 64
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group: 20 persons with dementia 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) will get a Tablet training including the same theratainment app as in the intervention group, but without the robot.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion criteria:

Persons with dementia:

* adults
* 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:

* 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

* adults
* nurses or nursing assistants
* speak and understand German

Dementia trainers

* adults
* trained as M.A.S. (Morbus Alzheimer Syndrome) trainer
* train the participants with dementia at home
* speak and understand German

Exclusion criteria:

Persons with dementia:

* frontotemporal dementia
* known aggressive behavior

Primary outcomes:
measure: Change of motivation (persons with dementia)
timeFrame: 3 weeks
measure: Change of care burden (relatives)
timeFrame: 3 weeks
Secondary outcomes:
measure: Change of quality of life (persons with dementia, relatives): The "Dementia Quality of Life Instrument"
timeFrame: 3 weeks
measure: Change of care dependency (persons with dementia)
timeFrame: 3 weeks
measure: Change of mobility (persons with dementia)
timeFrame: 3 weeks
measure: Change of cognition (persons with dementia)
timeFrame: 3 weeks
measure: Change of depression (persons with dementia, relatives)
timeFrame: 3 weeks
measure: Technology acceptance (persons with dementia, relatives, dementia trainers, professional caregivers)
timeFrame: 3 weeks
measure: Change of usability/acceptance (persons with dementia): semi-structured observation
timeFrame: 3 weeks
measure: Change of affect (relatives)
timeFrame: 3 weeks
measure: Change of behavioral problems (persons with dementia)
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
Study officials:
affiliation: Medical Univesity of Graz, Institute of Nursing Science
name: Sandra Schüssler, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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