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Clinical Trials/NCT03818217
NCT03818217
Completed
Not Applicable

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

Medical University of Graz1 site in 1 country64 target enrollmentMay 6, 2019
ConditionsDementia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dementia
Sponsor
Medical University of Graz
Enrollment
64
Locations
1
Primary Endpoint
Change of motivation (persons with dementia)
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 6, 2019
End Date
June 30, 2020
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Medical University of Graz
Responsible Party
Principal Investigator
Principal Investigator

Sandra Schüssler

Deputy Head of the Institute of Nursing Science

Medical University of Graz

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change of motivation (persons with dementia)

Time Frame: 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)

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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