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

NCT03818217 | Completed

• 1 other identifier: 30-401ex17/18
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Keywords

socially assistive robot; humanoid robot; motivation; home care; cognitive training; physical training; caregivers; dementia trainers; Computers, handheld

Outcome Measures

Primary Outcomes (2)

• Change of motivation (persons with dementia)

  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)

  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 Outcomes (9)

• 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 mobility (persons with dementia)

  3 weeks

• Change of cognition (persons with dementia)

  3 weeks

• Change of depression (persons with dementia, relatives)

  3 weeks

Study Arms (2)

Coach Pepper group

EXPERIMENTAL

Pepper is a humanoid socially assistive robot.

Device: Coach Pepper group

Tablet group

OTHER

Tablet training

Device: Tablet group

Interventions

Coach Pepper group DEVICE

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 .

Coach Pepper group

Tablet group DEVICE

The Tablet provides a theratainment app including cognitive and physical training.

Tablet group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Persons with dementia:
• frontotemporal dementia
• known aggressive behavior

Sponsors & Collaborators

• Medical University of Graz: lead
• Joanneum Research Forschungsgesellschaft mbH: collaborator
• Sozialverein Deutschlandsberg: collaborator
• Humanizing Technologies GmbH: collaborator

Study Sites (1)

Medical University of Graz

Graz, 8010, Austria

Location

Related Publications (11)

• ADI. Journey of caring: an analysis of long-term care for dementia. ADI, London, 2013

  BACKGROUND

• Bioethikkommission (Bioethics Commission). Roboter in der Betreuung alter Menschen - Stellungnahme der Bioethikkommission (Robots in the care of older people - statement of the Bioethics Commission). Geschäftsstelle der Bioethikkommission, Vienna, 2018

  BACKGROUND

• Boman IL, Lundberg S, Starkhammar S, Nygard L. Exploring the usability of a videophone mock-up for persons with dementia and their significant others. BMC Geriatr. 2014 Apr 16;14:49. doi: 10.1186/1471-2318-14-49.

  PMID: 24739662 BACKGROUND

• Lauriks S, Reinersmann A, Van der Roest HG, Meiland FJ, Davies RJ, Moelaert F, Mulvenna MD, Nugent CD, Droes RM. Review of ICT-based services for identified unmet needs in people with dementia. Ageing Res Rev. 2007 Oct;6(3):223-46. doi: 10.1016/j.arr.2007.07.002. Epub 2007 Aug 2.

  PMID: 17869590 BACKGROUND

• Mao HF, Chang LH, Yao G, Chen WY, Huang WN. Indicators of perceived useful dementia care assistive technology: Caregivers' perspectives. Geriatr Gerontol Int. 2015 Aug;15(8):1049-57. doi: 10.1111/ggi.12398. Epub 2014 Nov 19.

  PMID: 25407039 BACKGROUND

• NHI, WHO. Global Health and Aging http://www.who.int/ageing/publications/global_health.pdf. Accessed 18. Dezember 2017, 2011.

  BACKGROUND

• OECD. Adressing Dementia - the OECD response. OECD publishing, Paris, 2015.

  BACKGROUND

• Pino M, Boulay M, Jouen F, Rigaud AS. "Are we ready for robots that care for us?" Attitudes and opinions of older adults toward socially assistive robots. Front Aging Neurosci. 2015 Jul 23;7:141. doi: 10.3389/fnagi.2015.00141. eCollection 2015.

  PMID: 26257646 BACKGROUND

• Prince et al. World Alzheimer Report 2016 - Improving healthcare for people living with dementia. ADI, UK, 2016

  BACKGROUND

• Robert Koch Institut. Gesundheit in Deutschland. Gesundheitsberichterstattung des Bundes (Health in Germany. Health report of the federal government). Gemeinsam getragen von RKI und Destatis. RKI, Berlin, 2015

  BACKGROUND

• Wang RH, Sudhama A, Begum M, Huq R, Mihailidis A. Robots to assist daily activities: views of older adults with Alzheimer's disease and their caregivers. Int Psychogeriatr. 2017 Jan;29(1):67-79. doi: 10.1017/S1041610216001435. Epub 2016 Sep 23.

  PMID: 27660047 BACKGROUND

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Sandra Schüssler, Dr.

  Medical Univesity of Graz, Institute of Nursing Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking is not possible, because of the used interventions
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Head of the Institute of Nursing Science

Model Details: 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.

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 28, 2019
• Study Start: May 6, 2019
• Primary Completion: April 30, 2020
• Study Completion: June 30, 2020
• Last Updated: March 1, 2024

Record last verified: 2024-02

Locations

AU (1)