Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-24 @ 4:34 PM
Study NCT ID:
NCT03823066
Status:
COMPLETED
Last Update Posted:
2019-01-30
First Post:
2019-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Experience With a Robot for Home Care and Its Acceptance by People With Dementia, Caregivers and Dementia Trainers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'not possible'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'a humanoid socially assistive robot will be tested for people with dementia'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-29', 'studyFirstSubmitDate': '2019-01-09', 'studyFirstSubmitQcDate': '2019-01-29', 'lastUpdatePostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Technology acceptance (all participants): "Technology Usage Inventory"', 'timeFrame': '1 week', 'description': '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.'}, {'measure': 'Experience with the robot (all participants)', 'timeFrame': '1 week', 'description': 'Qualitative interviews with people with dementia. 1 qualitative focus group interview for all other participants.'}], 'secondaryOutcomes': [{'measure': 'Handling the robot (people with dementia)', 'timeFrame': 'After 3 days of intervention', 'description': 'Open, 1-hour semi-structured participant observation of people with dementia using the robot at home conducted by nurses.'}, {'measure': 'Change of mobility (people with dementia)', 'timeFrame': '1 week', 'description': 'Movement data collected by the eye camera of the robot.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acceptance', 'usability', 'home care', 'socially assistive robot', 'humanoid robot', 'caregivers', 'dementia trainers', 'cognitive training', 'physical training'], 'conditions': ['Dementia']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'ADI. Journey of caring: an analysis of long-term care for dementia. ADI, London, 2013'}, {'type': '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'}, {'pmid': '24739662', 'type': 'BACKGROUND', '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.'}, {'pmid': '17869590', 'type': 'BACKGROUND', '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.'}, {'pmid': '25407039', 'type': 'BACKGROUND', '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."}, {'type': 'BACKGROUND', 'citation': 'NHI, WHO. Global Health and Aging http://www.who.int/ageing/publications/ global_health.pdf. Accessed 18. Dezember 2017, 2011.'}, {'type': 'BACKGROUND', 'citation': 'OECD. Adressing Dementia - the OECD response. OECD publishing, Paris, 2015.'}, {'pmid': '26257646', 'type': 'BACKGROUND', '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.'}, {'type': 'BACKGROUND', 'citation': 'Prince et al. World Alzheimer Report 2016 - Improving healthcare for people living with dementia. ADI, UK, 2016'}, {'type': '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'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\nDementia 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.\n\nMethods\n\nThe 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.\n\nThis study helps to further refine and test a socially assistive robot for people with dementia living at home.'}, 'eligibilityModule': {'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPersons with dementia:\n\n* adults\n* living at home\n* all types of dementia\n* light and moderate dementia (MMSE 10 and above)\n* 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.)\n* moderate dementia: living with a relative at home\n* receive professional and/or non professional care or no care\n* speak and understand German\n* have no physical, auditory or visual restrictions, as this would make the application of the interventions impossible\n* 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\n* do not take antipsychotic and antidepressant medication or have been taking them for at least 14 days before study start\n* children and pets in the household after previous individual discussion\n\nRelatives:\n\n* relatives of the participating persons with dementia (adults)\n* relatives means family members, like spouse, daughter, aunt, ... or significant others like friends and neighbors\n* 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)\n* person with dementia receives or receives no professional care\n* the relative provides or does not provide care\n* 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).\n* speak and understand German\n\nProfessional caregivers\n\n* adults\n* nurses\n* speak and understand German\n\nDementia trainers\n\n* adults\n* trained as M.A.S. (Morbus Alzheimer Syndrome) trainer\n* train the participants with dementia at home\n* speak and understand German\n\nExclusioncCriteria:\n\nPersons with dementia:\n\n* known aggressive behavior\n* frontotemporal Dementia'}, 'identificationModule': {'nctId': 'NCT03823066', 'briefTitle': 'Experience With a Robot for Home Care and Its Acceptance by People With Dementia, Caregivers and Dementia Trainers', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '30-401ex17/18a'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Coach Pepper', 'description': 'Pepper is a humanoid socially assistive robot', 'interventionNames': ['Device: Coach Pepper']}], 'interventions': [{'name': 'Coach Pepper', 'type': 'DEVICE', '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", 'armGroupLabels': ['Coach Pepper']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8010', 'city': 'Graz', 'country': 'Austria', 'facility': 'Medical University of Graz, Institute of Nursing Science', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'collaborators': [{'name': 'Joanneum Research Forschungsgesellschaft mbH', 'class': 'OTHER'}, {'name': 'Sozialverein Deutschlandsberg', 'class': 'UNKNOWN'}, {'name': 'Humanizing Technologies GmbH', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Head of the Institute of Nursing Science', 'investigatorFullName': 'Sandra Schüssler', 'investigatorAffiliation': 'Medical University of Graz'}}}}