NCT03818217

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

Completed NA Last updated 1 March 2024

What this trial tests

NA trial testing Coach Pepper group in Dementia in 64 participants. Completed in 30 June 2020.

Timeline

6 May 2019

Primary endpoint
30 April 2020

30 June 2020

Quick facts

Lead sponsor	Medical University of Graz
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	64
Start date	6 May 2019
Primary completion	30 April 2020
Estimated completion	30 June 2020
Sites	1 location across Austria

Drugs / interventions tested

• Coach Pepper group
• Tablet group

Conditions studied

• Dementia — all drugs for Dementia →

Sponsor

Medical University of Graz

Who can join

Eligibility, any sex, with Dementia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Psychosocial effects of a humanoid robot on informal caregivers of people with dementia: A randomised controlled trial with nested interviews.
   Zuschnegg J, Häussl A, Lodron G, Orgel T, et al · · 2025 · cited 7× · PMID 39700737 · DOI 10.1016/j.ijnurstu.2024.104967