Back to results

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

Primary Purpose

Dementia

Status

Completed

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

Coach Pepper

About this trial

This is an interventional supportive care trial for Dementia focused on measuring acceptance, usability, home care, socially assistive robot, humanoid robot, caregivers, dementia trainers, cognitive training, physical training

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Does not accept healthy volunteers

Inclusion Criteria:

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)
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

Sites / Locations

Medical University of Graz, Institute of Nursing Science

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Coach Pepper

Arm Description

Pepper is a humanoid socially assistive robot

Outcomes

Primary Outcome Measures

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.

Experience with the robot (all participants)

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

Secondary Outcome Measures

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.

Change of mobility (people with dementia)

Movement data collected by the eye camera of the robot.

Full Information

NCT ID

NCT03823066

First Posted

January 9, 2019

Last Updated

January 29, 2019

Sponsor

Medical University of Graz

Collaborators

Joanneum Research Forschungsgesellschaft mbH, Sozialverein Deutschlandsberg, Humanizing Technologies GmbH

1. Study Identification

Unique Protocol Identification Number

NCT03823066

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

August 22, 2018 (Actual)

Primary Completion Date

September 18, 2018 (Actual)

Study Completion Date

September 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Graz

Collaborators

Joanneum Research Forschungsgesellschaft mbH, Sozialverein Deutschlandsberg, Humanizing Technologies GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dementia

Keywords

acceptance, usability, home care, socially assistive robot, humanoid robot, caregivers, dementia trainers, cognitive training, physical training

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

a humanoid socially assistive robot will be tested for people with dementia

Masking

None (Open Label)

Masking Description

not possible

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Coach Pepper

Arm Type

Experimental

Arm Description

Pepper is a humanoid socially assistive robot

Intervention Type

Device

Intervention Name(s)

Coach Pepper

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

1 week

Title

Experience with the robot (all participants)

Description

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

Time Frame

1 week

Secondary Outcome Measure Information:

Title

Handling the robot (people with dementia)

Description

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

Time Frame

After 3 days of intervention

Title

Change of mobility (people with dementia)

Description

Movement data collected by the eye camera of the robot.

Time Frame

1 week

10. Eligibility

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) 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

Facility Information:

Facility Name

Medical University of Graz, Institute of Nursing Science

City

Graz

ZIP/Postal Code

8010

Country

Austria

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

Citation

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

Results Reference

background

Citation

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

Results Reference

background

PubMed Identifier

24739662

Citation

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.

Results Reference

background

PubMed Identifier

17869590

Citation

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.

Results Reference

background

PubMed Identifier

25407039

Citation

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.

Results Reference

background

Citation

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

Results Reference

background

Citation

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

Results Reference

background

PubMed Identifier

26257646

Citation

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.

Results Reference

background

Citation

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

Results Reference

background

Citation

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

Results Reference

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs