Effects of a Robot on Physical and Psychosocial Outcomes of Persons With Dementia and Their Social Environment at Home

February 29, 2024 updated by: Sandra Schüssler, Medical University of Graz

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8010
        • Medical University of Graz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Coach Pepper group
Pepper is a humanoid socially assistive robot.
Device: Coach Pepper group

Robot Pepper's height is 1.20 meters and it weighs 28 kilograms. Pepper's operation time is about 12 hours.

Pepper will be called as Coach Pepper because s/he is virtually connected via web interfaces with a theratainment app including cognitive and physical training .
Other: Tablet group
Tablet training
Device: Tablet group
The Tablet provides a theratainment app including cognitive and physical training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
3 weeks
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.
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of quality of life (persons with dementia, relatives): The "Dementia Quality of Life Instrument"
Time Frame: 3 weeks
The "Dementia Quality of Life Instrument" will be used for the participants with dementia. The instrument has 28 items (4-point Likert scale) in 5 domains (self-esteem: 4 items; positive affect/humor- 6 items, negative affect - 11 items; feelings of belonging - 3 items; sense of aesthetics - 5 items). A global quality-of-life item is also included but does not contribute to the overall score. For every item, 1 to 4 points can be obtained, with higher scores indicating better quality of life. For the relatives, the short version of the "World Health Organization Quality of Life Scale" will be used. It has 26 items and 4 domains (physical health, psychological, social relationship, environment). For every item, 1-5 points can be obtained. In general, higher domain scores indicate a higher quality of life.
3 weeks
Change of care dependency (persons with dementia)
Time Frame: 3 weeks
The "Care Dependency Scale" has 15 items (5-point Likert scale). 15-75 points can be obtained. Lower scores indicate a higher degree of care dependency.
3 weeks
Change of mobility (persons with dementia)
Time Frame: 3 weeks
The "Timed UP and GO Test" measures the time (in seconds) an individual needs to stand up from a standard arm chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down. Interpretation: <10 seconds = completely unrestricted; 10-19 seconds = less mobile, but still unrestricted; 20 - 29 seconds = limited mobility; >30 seconds = pronounced mobility restriction. 14 seconds and more has been shown to indicate a high risk of falls. Furthermore, sensor data of the robot Pepper will be analysed (activity during physical training with the theratainment app).
3 weeks
Change of cognition (persons with dementia)
Time Frame: 3 weeks
The "Montreal Cognitive Assessment" has 30 items in 8 domains of cognitive functioning: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. 0-30 points can be obtained. Lower scores indicate a higher degree of cognitive impairment. Furthermore, sensor data of the theratainment app on the tablet will be analysed (performance of cognitive training).
3 weeks
Change of depression (persons with dementia, relatives)
Time Frame: 3 weeks
The short version of the "Geriatric Depression Scale" will be used for persons with dementia. The scale has 15 items (yes/no answers). 0-15 points can be obtained. Higher scores indicate a higher level of depressive symptoms. The "Center for Epidemiological Studies Depression Scale" will be used for the relatives. The scale has 20 items (4-point Likert scale). 0-60 points can be obtained. Higher scores indicate a higher level of depressive symptoms.
3 weeks
Change of usability/acceptance (persons with dementia): semi-structured observation
Time Frame: 3 weeks
An open, semi-structured observation of persons with dementia interacting with the robot at home will be conducted by professional caregivers.
3 weeks
Change of affect (relatives)
Time Frame: 3 weeks
The "Positive and Negative Affect Schedule" has 20 items (5-point Likert scale) with 2 dimensions (positive affect, negative affect). In total, 20 - 100 points can be obtained. Higher scores indicate higher positive or rather negative affect.
3 weeks
Change of behavioral problems (persons with dementia)
Time Frame: 3 weeks
The "Neuropsychiatric Inventory (NPI)" has 12 dimensions (delusions, agitation/aggression, depression, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability, aberrant motor behavior, sleep and night-time behavior disorders, appetite and eating disorders). Each of the 12 domains is rated in terms of severity (ranging from 0 = absent to 3 = severe) and frequency (ranging from 1 = rare to 4 = frequent). The score of each item is then calculated by multiplying severity by frequency, thus obtaining a score ranging between 0 and 12. The total NPI score is finally obtained by adding all the single item scores (thus, ranging from 0 to 144). Higher scores indicate greater psychopathology.
3 weeks
Technology acceptance (persons with dementia, relatives, dementia trainers, professional caregivers)
Time Frame: 3 weeks
The "Technology Usage Inventory" measures acceptance with 9 scales (curiosity, anxiety, interest, usability/user friendliness, immersion, utility, skepticism and accessibility, intention to use) and 30 items (7-point Likert scale). 26-182 points can be obtained (except for the scale "Intention to Use", which is a visual analogue scale with a ten-centimeter-long horizontal line with the two end-points "agree" and "disagree". A cross on the line indicates the degree of agreement. For the evaluation, the distance from the right end-point (disagreement) to the answer cross on the line is measured. This distance (in millimeters) is determined and summed up for all three items (maximum:300, Minimum:0). For all scales, higher levels on the respective scales indicate a higher level of expression in the respective construct. Additionally, individual interviews (people with dementia, relatives) and focus groups (other participants) will be conducted to obtain more in-deep knowledge
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Collaborators

Joanneum Research Forschungsgesellschaft mbH
Sozialverein Deutschlandsberg
Humanizing Technologies GmbH

Investigators

  • Principal Investigator: Sandra Schüssler, Dr., Medical Univesity of Graz, Institute of Nursing Science

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2019

Primary Completion (Actual)

April 30, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

January 9, 2019

First Submitted That Met QC Criteria

January 25, 2019

First Posted (Actual)

January 28, 2019

Study Record Updates

Last Update Posted (Actual)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 30-401ex17/18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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