<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03823066</url>
  </required_header>
  <id_info>
    <org_study_id>30-401ex17/18a</org_study_id>
    <nct_id>NCT03823066</nct_id>
  </id_info>
  <brief_title>Experience With a Robot for Home Care and Its Acceptance by People With Dementia, Caregivers and Dementia Trainers</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Graz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Joanneum Research Forschungsgesellschaft mbH</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sozialverein Deutschlandsberg</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Humanizing Technologies GmbH</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University of Graz</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      Dementia rates are increasing worldwide and consequently burden global healthcare resources&#xD;
      to a serious degree. However, there is a declining number of caregivers to provide care. It&#xD;
      is for this reason that many new technologies, such as socially assistive robots, have been&#xD;
      developed because of their potential to support caregivers in promoting the independence of&#xD;
      people with dementia. Most of the (socially assistive) robots have so far been tested for&#xD;
      people without dementia in mainly laboratory or institutional settings, like nursing homes.&#xD;
      Consequently, there is a lack of knowledge about the possible uses of robots from the&#xD;
      perspective of those affected by dementia in real-life/care situations (e.g. at home).&#xD;
      Testing in a laboratory setting cannot capture the complexity and high variability of&#xD;
      everyday situations occurring during the care of persons with dementia.&#xD;
&#xD;
      Methods&#xD;
&#xD;
      The design is a mixed method intervention study of a refined socially assistive humanoid&#xD;
      robot. In total, three people with dementia, three relatives, three dementia trainers and&#xD;
      three professional caregivers were included in the study. Quantitative data of technology&#xD;
      acceptance were collected using the &quot;Technology Usage Inventory&quot;. Qualitative data (main&#xD;
      focus: experiences with the robot and handling the robot) were collected by means of&#xD;
      observation and qualitative interviews. Movement data of people with dementia were collected&#xD;
      by means of the eye camera of the robot.&#xD;
&#xD;
      This study helps to further refine and test a socially assistive robot for people with&#xD;
      dementia living at home.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 22, 2018</start_date>
  <completion_date type="Actual">September 18, 2018</completion_date>
  <primary_completion_date type="Actual">September 18, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>a humanoid socially assistive robot will be tested for people with dementia</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>not possible</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Technology acceptance (all participants): &quot;Technology Usage Inventory&quot;</measure>
    <time_frame>1 week</time_frame>
    <description>The questionnaire &quot;Technology Usage Inventory&quot; 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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Experience with the robot (all participants)</measure>
    <time_frame>1 week</time_frame>
    <description>Qualitative interviews with people with dementia. 1 qualitative focus group interview for all other participants.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Handling the robot (people with dementia)</measure>
    <time_frame>After 3 days of intervention</time_frame>
    <description>Open, 1-hour semi-structured participant observation of people with dementia using the robot at home conducted by nurses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of mobility (people with dementia)</measure>
    <time_frame>1 week</time_frame>
    <description>Movement data collected by the eye camera of the robot.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Dementia</condition>
  <arm_group>
    <arm_group_label>Coach Pepper</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pepper is a humanoid socially assistive robot</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Coach Pepper</intervention_name>
    <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</description>
    <arm_group_label>Coach Pepper</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Persons with dementia:&#xD;
&#xD;
          -  adults&#xD;
&#xD;
          -  living at home&#xD;
&#xD;
          -  all types of dementia&#xD;
&#xD;
          -  light and moderate dementia (MMSE 10 and above)&#xD;
&#xD;
          -  light dementia: living alone or with a relative at home (if alone: the relative should&#xD;
             live in the neighborhood and be in daily contact with the person with dementia.)&#xD;
&#xD;
          -  moderate dementia: living with a relative at home&#xD;
&#xD;
          -  receive professional and/or non professional care or no care&#xD;
&#xD;
          -  speak and understand German&#xD;
&#xD;
          -  have no physical, auditory or visual restrictions, as this would make the application&#xD;
             of the interventions impossible&#xD;
&#xD;
          -  do not take any dementia-specific medication or have been taking dementia-specific&#xD;
             medication for at least 3 months; condition stable and no change expected during the&#xD;
             study period&#xD;
&#xD;
          -  do not take antipsychotic and antidepressant medication or have been taking them for&#xD;
             at least 14 days before study start&#xD;
&#xD;
          -  children and pets in the household after previous individual discussion&#xD;
&#xD;
        Relatives:&#xD;
&#xD;
          -  relatives of the participating persons with dementia (adults)&#xD;
&#xD;
          -  relatives means family members, like spouse, daughter, aunt, ... or significant others&#xD;
             like friends and neighbors&#xD;
&#xD;
          -  living or not living with the person with dementia in the same household (in the case&#xD;
             of moderate dementia, relatives must live in the same household)&#xD;
&#xD;
          -  person with dementia receives or receives no professional care&#xD;
&#xD;
          -  the relative provides or does not provide care&#xD;
&#xD;
          -  If the person with dementia receives paid 24-hour care (regardless of whether they&#xD;
             have mild or moderate dementia), a relative still has to be recruited as a participant&#xD;
             (This relative must live in the same house or household and be in daily contact with&#xD;
             the person with dementia).&#xD;
&#xD;
          -  speak and understand German&#xD;
&#xD;
        Professional caregivers&#xD;
&#xD;
          -  adults&#xD;
&#xD;
          -  nurses&#xD;
&#xD;
          -  speak and understand German&#xD;
&#xD;
        Dementia trainers&#xD;
&#xD;
          -  adults&#xD;
&#xD;
          -  trained as M.A.S. (Morbus Alzheimer Syndrome) trainer&#xD;
&#xD;
          -  train the participants with dementia at home&#xD;
&#xD;
          -  speak and understand German&#xD;
&#xD;
        ExclusioncCriteria:&#xD;
&#xD;
        Persons with dementia:&#xD;
&#xD;
          -  known aggressive behavior&#xD;
&#xD;
          -  frontotemporal Dementia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Medical University of Graz, Institute of Nursing Science</name>
      <address>
        <city>Graz</city>
        <zip>8010</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <reference>
    <citation>ADI. Journey of caring: an analysis of long-term care for dementia. ADI, London, 2013</citation>
  </reference>
  <reference>
    <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</citation>
  </reference>
  <reference>
    <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.</citation>
    <PMID>24739662</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>17869590</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25407039</PMID>
  </reference>
  <reference>
    <citation>NHI, WHO. Global Health and Aging http://www.who.int/ageing/publications/ global_health.pdf. Accessed 18. Dezember 2017, 2011.</citation>
  </reference>
  <reference>
    <citation>OECD. Adressing Dementia - the OECD response. OECD publishing, Paris, 2015.</citation>
  </reference>
  <reference>
    <citation>Pino M, Boulay M, Jouen F, Rigaud AS. &quot;Are we ready for robots that care for us?&quot; 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.</citation>
    <PMID>26257646</PMID>
  </reference>
  <reference>
    <citation>Prince et al. World Alzheimer Report 2016 - Improving healthcare for people living with dementia. ADI, UK, 2016</citation>
  </reference>
  <reference>
    <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</citation>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>January 29, 2019</last_update_submitted>
  <last_update_submitted_qc>January 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Graz</investigator_affiliation>
    <investigator_full_name>Sandra Schüssler</investigator_full_name>
    <investigator_title>Deputy Head of the Institute of Nursing Science</investigator_title>
  </responsible_party>
  <keyword>acceptance</keyword>
  <keyword>usability</keyword>
  <keyword>home care</keyword>
  <keyword>socially assistive robot</keyword>
  <keyword>humanoid robot</keyword>
  <keyword>caregivers</keyword>
  <keyword>dementia trainers</keyword>
  <keyword>cognitive training</keyword>
  <keyword>physical training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03823066
org study id: 30-401ex17/18a
nct id: NCT03823066
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: a humanoid socially assistive robot will be tested for people with dementia
primary purpose: Supportive Care
masking: None (Open Label)
masking description: not possible
measure: Technology acceptance (all participants): "Technology Usage Inventory"
time frame: 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)
time frame: 1 week
description: Qualitative interviews with people with dementia. 1 qualitative focus group interview for all other participants.
measure: Handling the robot (people with dementia)
time frame: 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)
time frame: 1 week
description: Movement data collected by the eye camera of the robot.
arm group label: Coach Pepper
arm group type: Experimental
description: Pepper is a humanoid socially assistive robot
intervention type: Device
intervention name: Coach Pepper
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
arm group label: Coach Pepper
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Austria
citation: ADI. Journey of caring: an analysis of long-term care for dementia. ADI, London, 2013
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
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: 24739662
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: 17869590
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.
PMID: 25407039
citation: NHI, WHO. Global Health and Aging http://www.who.int/ageing/publications/ global_health.pdf. Accessed 18. Dezember 2017, 2011.
citation: OECD. Adressing Dementia - the OECD response. OECD publishing, Paris, 2015.
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.
PMID: 26257646
citation: Prince et al. World Alzheimer Report 2016 - Improving healthcare for people living with dementia. ADI, UK, 2016
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
responsible party type: Principal Investigator
investigator affiliation: Medical University of Graz
investigator full name: Sandra Schüssler
investigator title: Deputy Head of the Institute of Nursing Science
mesh term: Dementia
sharing ipd: Undecided