<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/NCT03818217</url>
  </required_header>
  <id_info>
    <org_study_id>30-401ex17/18</org_study_id>
    <nct_id>NCT03818217</nct_id>
  </id_info>
  <brief_title>Effects of a Robot on Physical and Psychosocial Outcomes of Persons With Dementia and Their Social Environment at Home</brief_title>
  <official_title>Effects of a Socially Assistive Robot Coach on Physical and Psychosocial Outcomes of Caregivers, Dementia Trainers and Persons With Dementia Living at Home: a Mixed Method Randomized Clinical Trial</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.&#xD;
&#xD;
      Most of the (socially assistive) robots have so far been tested for people without dementia&#xD;
      in mainly laboratory or in institutional settings, like nursing homes. Consequently, there is&#xD;
      a lack of knowledge about the possible uses of robots from the perspective of those affected&#xD;
      by dementia in real-life/care situations (e.g. at home). Testing in a laboratory setting&#xD;
      cannot capture the complexity and high variability of everyday situations occurring during&#xD;
      the care of persons with dementia.&#xD;
&#xD;
      Aim:&#xD;
&#xD;
      The aim is to investigate the effect of a socially assistive humanoid robot on the physical&#xD;
      and psychosocial outcomes of caregivers, dementia trainers and persons with dementia living&#xD;
      at home.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      The design is a mixed method randomized clinical trial. As an intervention, 20 persons with&#xD;
      dementia will receive a socially assistive humanoid robot coach (including a theratainment&#xD;
      app for physical and cognitive exercises). The control group (also 20 persons with dementia)&#xD;
      will receive a tablet including the same theratainment app as in the intervention group, but&#xD;
      without the robot.&#xD;
&#xD;
      Data will be collected using sensor data of the robot and the tablet, eye tracking,&#xD;
      questionnaires, observation and interviews. There are also questionnaires for the relatives&#xD;
      (n=40), dementia trainers (n=5) and professional caregivers (n=5).&#xD;
&#xD;
      Data analysis is quantitative (descriptive statistics, median regression, covariance&#xD;
      analysis) and qualitative (content analysis).&#xD;
&#xD;
      The planned study supports the further development of socially assistive robots with regard&#xD;
      to the individual needs of persons with dementia living at home.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 6, 2019</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">April 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Intervention group: 20 persons with dementia will receive a socially assistive humanoid robot coach (including a theratainment app for physical and cognitive exercises).&#xD;
The control group (also 20 persons with dementia) will get a Tablet training including the same theratainment app as in the intervention group, but without the robot.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Masking is not possible, because of the used interventions</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change of motivation (persons with dementia)</measure>
    <time_frame>3 weeks</time_frame>
    <description>The &quot;Apathy Evaluation Scale&quot; is a scale to measure motivation because apathy can be understood as a loss of motivation. The scale has 18 items (4-point Likert scale). 18-72 points can be obtained. Higher scores correspond to a higher degree of apathy and therefore lower motivation. Furthermore, sensor data of the robot Pepper/ the tablet will be analysed (usage of different functions).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of care burden (relatives)</measure>
    <time_frame>3 weeks</time_frame>
    <description>The &quot;Zarid Burden Interview&quot; captures the subjective burden of caregivers. The instrument has 22 items (5-point Likert scale). 0 - 88 points can be obtained. Higher scores indicate greater caregiver distress.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of quality of life (persons with dementia, relatives): The &quot;Dementia Quality of Life Instrument&quot;</measure>
    <time_frame>3 weeks</time_frame>
    <description>The &quot;Dementia Quality of Life Instrument&quot; will be used for the participants with dementia. The instrument has 28 items (4-point Likert scale) in 5 domains (self-esteem: 4 items; positive affect/humor- 6 items, negative affect - 11 items; feelings of belonging - 3 items; sense of aesthetics - 5 items). A global quality-of-life item is also included but does not contribute to the overall score. For every item, 1 to 4 points can be obtained, with higher scores indicating better quality of life. For the relatives, the short version of the &quot;World Health Organization Quality of Life Scale&quot; will be used. It has 26 items and 4 domains (physical health, psychological, social relationship, environment). For every item, 1-5 points can be obtained. In general, higher domain scores indicate a higher quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of care dependency (persons with dementia)</measure>
    <time_frame>3 weeks</time_frame>
    <description>The &quot;Care Dependency Scale&quot; has 15 items (5-point Likert scale). 15-75 points can be obtained. Lower scores indicate a higher degree of care dependency.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of mobility (persons with dementia)</measure>
    <time_frame>3 weeks</time_frame>
    <description>The &quot;Timed UP and GO Test&quot; measures the time (in seconds) an individual needs to stand up from a standard arm chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down. Interpretation: &lt;10 seconds = completely unrestricted; 10-19 seconds = less mobile, but still unrestricted; 20 - 29 seconds = limited mobility; &gt;30 seconds = pronounced mobility restriction. 14 seconds and more has been shown to indicate a high risk of falls. Furthermore, sensor data of the robot Pepper will be analysed (activity during physical training with the theratainment app).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of cognition (persons with dementia)</measure>
    <time_frame>3 weeks</time_frame>
    <description>The &quot;Montreal Cognitive Assessment&quot; has 30 items in 8 domains of cognitive functioning: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. 0-30 points can be obtained. Lower scores indicate a higher degree of cognitive impairment. Furthermore, sensor data of the theratainment app on the tablet will be analysed (performance of cognitive training).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of depression (persons with dementia, relatives)</measure>
    <time_frame>3 weeks</time_frame>
    <description>The short version of the &quot;Geriatric Depression Scale&quot; will be used for persons with dementia. The scale has 15 items (yes/no answers). 0-15 points can be obtained. Higher scores indicate a higher level of depressive symptoms. The &quot;Center for Epidemiological Studies Depression Scale&quot; will be used for the relatives. The scale has 20 items (4-point Likert scale). 0-60 points can be obtained. Higher scores indicate a higher level of depressive symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technology acceptance (persons with dementia, relatives, dementia trainers, professional caregivers)</measure>
    <time_frame>3 weeks</time_frame>
    <description>The &quot;Technology Usage Inventory&quot; measures acceptance with 9 scales (curiosity, anxiety, interest, usability/user friendliness, immersion, utility, skepticism and accessibility, intention to use) and 30 items (7-point Likert scale). 26-182 points can be obtained (except for the scale &quot;Intention to Use&quot;, which is a visual analogue scale with a ten-centimeter-long horizontal line with the two end-points &quot;agree&quot; and &quot;disagree&quot;. A cross on the line indicates the degree of agreement. For the evaluation, the distance from the right end-point (disagreement) to the answer cross on the line is measured. This distance (in millimeters) is determined and summed up for all three items (maximum:300, Minimum:0). For all scales, higher levels on the respective scales indicate a higher level of expression in the respective construct. Additionally, individual interviews (people with dementia) and focus groups (other participants) will be conducted to obtain more in-deep knowledge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of usability/acceptance (persons with dementia): semi-structured observation</measure>
    <time_frame>3 weeks</time_frame>
    <description>An open, semi-structured observation of persons with dementia interacting with the robot at home will be conducted by professional caregivers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of affect (relatives)</measure>
    <time_frame>3 weeks</time_frame>
    <description>The &quot;Positive and Negative Affect Schedule&quot; has 20 items (5-point Likert scale) with 2 dimensions (positive affect, negative affect). In total, 20 - 100 points can be obtained. Higher scores indicate higher positive or rather negative affect.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of behavioral problems (persons with dementia)</measure>
    <time_frame>3 weeks</time_frame>
    <description>The &quot;Neuropsychiatric Inventory (NPI)&quot; has 12 dimensions (delusions, agitation/aggression, depression, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability, aberrant motor behavior, sleep and night-time behavior disorders, appetite and eating disorders). Each of the 12 domains is rated in terms of severity (ranging from 0 = absent to 3 = severe) and frequency (ranging from 1 = rare to 4 = frequent). The score of each item is then calculated by multiplying severity by frequency, thus obtaining a score ranging between 0 and 12. The total NPI score is finally obtained by adding all the single item scores (thus, ranging from 0 to 144). Higher scores indicate greater psychopathology.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">95</enrollment>
  <condition>Dementia</condition>
  <arm_group>
    <arm_group_label>Coach Pepper group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pepper is a humanoid socially assistive robot.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tablet group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Tablet training</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Coach Pepper group</intervention_name>
    <description>Robot Pepper's height is 1.20 meters and it weighs 28 kilograms. Pepper's operation time is about 12 hours.&#xD;
Pepper will be called as Coach Pepper because s/he is virtually connected via web interfaces with a theratainment app including cognitive and physical training .</description>
    <arm_group_label>Coach Pepper group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tablet group</intervention_name>
    <description>The Tablet provides a theratainment app including cognitive and physical training.</description>
    <arm_group_label>Tablet group</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 (except frontotemporal dementia)&#xD;
&#xD;
          -  light and moderate dementia (MMSE 10 and above)&#xD;
&#xD;
          -  light dementia: living alone or with 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, which would make the application of&#xD;
             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 antipsychotics and antidepressants or have been taking them for at least&#xD;
             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;
          -  relative provides or does not provide care&#xD;
&#xD;
          -  if the persons with dementia receive 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 or nursing assistants&#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;
        Exclusion criteria:&#xD;
&#xD;
        Persons with dementia:&#xD;
&#xD;
          -  frontotemporal dementia&#xD;
&#xD;
          -  known aggressive behavior&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sandra Schüssler, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical Univesity of Graz, Institute of Nursing Science</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of Graz</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>
  <reference>
    <citation>Wang RH, Sudhama A, Begum M, Huq R, Mihailidis A. Robots to assist daily activities: views of older adults with Alzheimer's disease and their caregivers. Int Psychogeriatr. 2017 Jan;29(1):67-79. doi: 10.1017/S1041610216001435. Epub 2016 Sep 23.</citation>
    <PMID>27660047</PMID>
  </reference>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>August 25, 2022</last_update_submitted>
  <last_update_submitted_qc>August 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 26, 2022</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>socially assistive robot</keyword>
  <keyword>humanoid robot</keyword>
  <keyword>motivation</keyword>
  <keyword>home care</keyword>
  <keyword>cognitive training</keyword>
  <keyword>physical training</keyword>
  <keyword>caregivers</keyword>
  <keyword>dementia trainers</keyword>
  <keyword>Computers, handheld</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/NCT03818217
org study id: 30-401ex17/18
nct id: NCT03818217
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 in 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.

      Aim:

      The aim is to investigate the effect of a socially assistive humanoid robot on the physical
      and psychosocial outcomes of caregivers, dementia trainers and persons with dementia living
      at home.

      Methods:

      The design is a mixed method randomized clinical trial. As an intervention, 20 persons with
      dementia will receive a socially assistive humanoid robot coach (including a theratainment
      app for physical and cognitive exercises). The control group (also 20 persons with dementia)
      will receive a tablet including the same theratainment app as in the intervention group, but
      without the robot.

      Data will be collected using sensor data of the robot and the tablet, eye tracking,
      questionnaires, observation and interviews. There are also questionnaires for the relatives
      (n=40), dementia trainers (n=5) and professional caregivers (n=5).

      Data analysis is quantitative (descriptive statistics, median regression, covariance
      analysis) and qualitative (content analysis).

      The planned study supports the further development of socially assistive robots with regard
      to the individual needs of persons with dementia living at home.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Intervention group: 20 persons with dementia will receive a socially assistive humanoid robot coach (including a theratainment app for physical and cognitive exercises).
The control group (also 20 persons with dementia) will get a Tablet training including the same theratainment app as in the intervention group, but without the robot.
primary purpose: Supportive Care
masking: None (Open Label)
masking description: Masking is not possible, because of the used interventions
measure: Change of motivation (persons with dementia)
time frame: 3 weeks
description: The "Apathy Evaluation Scale" is a scale to measure motivation because apathy can be understood as a loss of motivation. The scale has 18 items (4-point Likert scale). 18-72 points can be obtained. Higher scores correspond to a higher degree of apathy and therefore lower motivation. Furthermore, sensor data of the robot Pepper/ the tablet will be analysed (usage of different functions).
measure: Change of care burden (relatives)
time frame: 3 weeks
description: The "Zarid Burden Interview" captures the subjective burden of caregivers. The instrument has 22 items (5-point Likert scale). 0 - 88 points can be obtained. Higher scores indicate greater caregiver distress.
measure: Change of quality of life (persons with dementia, relatives): The "Dementia Quality of Life Instrument"
time frame: 3 weeks
description: The "Dementia Quality of Life Instrument" will be used for the participants with dementia. The instrument has 28 items (4-point Likert scale) in 5 domains (self-esteem: 4 items; positive affect/humor- 6 items, negative affect - 11 items; feelings of belonging - 3 items; sense of aesthetics - 5 items). A global quality-of-life item is also included but does not contribute to the overall score. For every item, 1 to 4 points can be obtained, with higher scores indicating better quality of life. For the relatives, the short version of the "World Health Organization Quality of Life Scale" will be used. It has 26 items and 4 domains (physical health, psychological, social relationship, environment). For every item, 1-5 points can be obtained. In general, higher domain scores indicate a higher quality of life.
measure: Change of care dependency (persons with dementia)
time frame: 3 weeks
description: The "Care Dependency Scale" has 15 items (5-point Likert scale). 15-75 points can be obtained. Lower scores indicate a higher degree of care dependency.
measure: Change of mobility (persons with dementia)
time frame: 3 weeks
description: The "Timed UP and GO Test" measures the time (in seconds) an individual needs to stand up from a standard arm chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down. Interpretation: <10 seconds = completely unrestricted; 10-19 seconds = less mobile, but still unrestricted; 20 - 29 seconds = limited mobility; >30 seconds = pronounced mobility restriction. 14 seconds and more has been shown to indicate a high risk of falls. Furthermore, sensor data of the robot Pepper will be analysed (activity during physical training with the theratainment app).
measure: Change of cognition (persons with dementia)
time frame: 3 weeks
description: The "Montreal Cognitive Assessment" has 30 items in 8 domains of cognitive functioning: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. 0-30 points can be obtained. Lower scores indicate a higher degree of cognitive impairment. Furthermore, sensor data of the theratainment app on the tablet will be analysed (performance of cognitive training).
measure: Change of depression (persons with dementia, relatives)
time frame: 3 weeks
description: The short version of the "Geriatric Depression Scale" will be used for persons with dementia. The scale has 15 items (yes/no answers). 0-15 points can be obtained. Higher scores indicate a higher level of depressive symptoms. The "Center for Epidemiological Studies Depression Scale" will be used for the relatives. The scale has 20 items (4-point Likert scale). 0-60 points can be obtained. Higher scores indicate a higher level of depressive symptoms.
measure: Technology acceptance (persons with dementia, relatives, dementia trainers, professional caregivers)
time frame: 3 weeks
description: The "Technology Usage Inventory" measures acceptance with 9 scales (curiosity, anxiety, interest, usability/user friendliness, immersion, utility, skepticism and accessibility, intention to use) and 30 items (7-point Likert scale). 26-182 points can be obtained (except for the scale "Intention to Use", which is a visual analogue scale with a ten-centimeter-long horizontal line with the two end-points "agree" and "disagree". A cross on the line indicates the degree of agreement. For the evaluation, the distance from the right end-point (disagreement) to the answer cross on the line is measured. This distance (in millimeters) is determined and summed up for all three items (maximum:300, Minimum:0). For all scales, higher levels on the respective scales indicate a higher level of expression in the respective construct. Additionally, individual interviews (people with dementia) and focus groups (other participants) will be conducted to obtain more in-deep knowledge
measure: Change of usability/acceptance (persons with dementia): semi-structured observation
time frame: 3 weeks
description: An open, semi-structured observation of persons with dementia interacting with the robot at home will be conducted by professional caregivers.
measure: Change of affect (relatives)
time frame: 3 weeks
description: The "Positive and Negative Affect Schedule" has 20 items (5-point Likert scale) with 2 dimensions (positive affect, negative affect). In total, 20 - 100 points can be obtained. Higher scores indicate higher positive or rather negative affect.
measure: Change of behavioral problems (persons with dementia)
time frame: 3 weeks
description: The "Neuropsychiatric Inventory (NPI)" has 12 dimensions (delusions, agitation/aggression, depression, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability, aberrant motor behavior, sleep and night-time behavior disorders, appetite and eating disorders). Each of the 12 domains is rated in terms of severity (ranging from 0 = absent to 3 = severe) and frequency (ranging from 1 = rare to 4 = frequent). The score of each item is then calculated by multiplying severity by frequency, thus obtaining a score ranging between 0 and 12. The total NPI score is finally obtained by adding all the single item scores (thus, ranging from 0 to 144). Higher scores indicate greater psychopathology.
arm group label: Coach Pepper group
arm group type: Experimental
description: Pepper is a humanoid socially assistive robot.
arm group label: Tablet group
arm group type: Other
description: Tablet training
intervention type: Device
intervention name: Coach Pepper group
description: Robot Pepper's height is 1.20 meters and it weighs 28 kilograms. Pepper's operation time is about 12 hours.
Pepper will be called as Coach Pepper because s/he is virtually connected via web interfaces with a theratainment app including cognitive and physical training .
arm group label: Coach Pepper group
intervention type: Device
intervention name: Tablet group
description: The Tablet provides a theratainment app including cognitive and physical training.
arm group label: Tablet group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Sandra Schüssler, Dr.
role: Principal Investigator
affiliation: Medical Univesity of Graz, Institute of Nursing Science
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
citation: Wang RH, Sudhama A, Begum M, Huq R, Mihailidis A. Robots to assist daily activities: views of older adults with Alzheimer's disease and their caregivers. Int Psychogeriatr. 2017 Jan;29(1):67-79. doi: 10.1017/S1041610216001435. Epub 2016 Sep 23.
PMID: 27660047
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