NCT03823066

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 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. Methods The design is a mixed method intervention study of a refined socially assistive humanoid robot. In total, three people with dementia, three relatives, three dementia trainers and three professional caregivers were included in the study. Quantitative data of technology acceptance were collected using the "Technology Usage Inventory". Qualitative data (main focus: experiences with the robot and handling the robot) were collected by means of observation and qualitative interviews. Movement data of people with dementia were collected by means of the eye camera of the robot. This study helps to further refine and test a socially assistive robot for people with dementia living at home.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 22, 2018

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 30, 2019

Completed
Last Updated

January 30, 2019

Status Verified

January 1, 2019

Enrollment Period

27 days

First QC Date

January 9, 2019

Last Update Submit

January 29, 2019

Conditions

Keywords

acceptanceusabilityhome caresocially assistive robothumanoid robotcaregiversdementia trainerscognitive trainingphysical training

Outcome Measures

Primary Outcomes (2)

  • Technology acceptance (all participants): "Technology Usage Inventory"

    The questionnaire "Technology Usage Inventory" measures technology acceptance. It captures technology-specific and psychological factors contributing to the use of a technological device. The questionnaire has 8 dimensions (curiosity:4 items, anxiety:4 items, interest:4 items, usability/user-friendliness: 3 items, immersion:4 items, utility:4 items, skepticism:4 items and accessibility:3 items) with 30 items (7-point Likert scale). For every dimension 1- 21 or 28 points can be obtained. For all dimensions, higher levels on the respective dimension indicate a higher level of expression in the respective construct.

    1 week

  • Experience with the robot (all participants)

    Qualitative interviews with people with dementia. 1 qualitative focus group interview for all other participants.

    1 week

Secondary Outcomes (2)

  • Handling the robot (people with dementia)

    After 3 days of intervention

  • Change of mobility (people with dementia)

    1 week

Study Arms (1)

Coach Pepper

EXPERIMENTAL

Pepper is a humanoid socially assistive robot

Device: Coach Pepper

Interventions

Robot Peppers's height is 1.20 meters and it weighs 28 kilograms. Pepper will be called Coach Pepper, because it is connected, via web interfaces, with a theratainment app including cognitive and physical training

Coach Pepper

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Persons with dementia:
  • adults
  • living at home
  • all types of dementia
  • light and moderate dementia (MMSE 10 and above)
  • light dementia: living alone or with a 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, as this 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 antipsychotic and antidepressant medication 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)
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz, Institute of Nursing Science

Graz, 8010, Austria

Location

Related Publications (10)

  • 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: 24739662BACKGROUND
  • 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: 17869590BACKGROUND
  • 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: 25407039BACKGROUND
  • 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: 26257646BACKGROUND
  • 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

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
not possible
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: a humanoid socially assistive robot will be tested for people with dementia
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Head of the Institute of Nursing Science

Study Record Dates

First Submitted

January 9, 2019

First Posted

January 30, 2019

Study Start

August 22, 2018

Primary Completion

September 18, 2018

Study Completion

September 18, 2018

Last Updated

January 30, 2019

Record last verified: 2019-01

Locations