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DementiaNCT03823066

Experience With a Robot for Home Care and Its Acceptance by People With Dementia, Caregivers and Dementia Trainers

A study testing Coach Pepper in people with Dementia, run by Medical University of Graz at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Dementia
What is being tested?
Coach Pepper
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteAustria
Study dates
22 Aug 2018to 18 Sep 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.)
Show all 34Show fewer
  • 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)
  • 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
  • the relative provides or does not provide care
  • If the person with dementia receives 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
  • 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
  • ExclusioncCriteria:
  • Persons with dementia:
  • known aggressive behavior
  • frontotemporal Dementia

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • Medical University of Graz, Institute of Nursing Science

    Graz, 8010

Other trials in Austria

About this study

Official title: Experience With a Socially Assistive Robot for Home Care and Its Acceptance by People With Dementia, Caregivers and Dementia Trainers. A Mixed-method Intervention Study

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.

Read more

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.

Conditions
Dementia
Being tested
Coach Pepper
Keywords
acceptance, usability, home care, socially assistive robot, humanoid robot, caregivers, dementia trainers, cognitive training, physical training
Medical subject headings
Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coach PepperDevice

    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

Study groups in NCT03823066
Study groupRoleWhat they receive
Coach PepperExperimentalPepper is a humanoid socially assistive robot
Receives: Device: Coach Pepper

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 week

  2. Experience with the robot (all participants)

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

    Measured: 1 week

Secondary outcomes (2)

  1. Handling the robot (people with dementia)

    Open, 1-hour semi-structured participant observation of people with dementia using the robot at home conducted by nurses.

    Measured: After 3 days of intervention

  2. Change of mobility (people with dementia)

    Movement data collected by the eye camera of the robot.

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2019
  2. Study start22 Aug 2018
  3. Primary completion18 Sep 2018
  4. Study completion18 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
a humanoid socially assistive robot will be tested for people with dementia
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03823066
Sponsor's protocol ID
30-401ex17/18a
Status last verified
Jan 2019
First submitted
9 Jan 2019
Last updated
30 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

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

  • 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

  • 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.

    PubMed 24739662

  • 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.

    PubMed 17869590

  • 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.

    PubMed 25407039

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

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

  • 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.

    PubMed 26257646

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

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Coach Pepper in people with Dementia, run by Medical University of Graz at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 34 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Technology acceptance (all participants): "Technology Usage Inventory" (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03823066, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2019.

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