<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/NCT03756194</url>
  </required_header>
  <id_info>
    <org_study_id>CARESSES No 737858</org_study_id>
    <nct_id>NCT03756194</nct_id>
  </id_info>
  <brief_title>CARESSES Testing and Evaluation Phases</brief_title>
  <acronym>CARESSES</acronym>
  <official_title>'Culture-Aware Robots and Environmental Sensor Systems for Elderly Support' (CARESSES) - Testing and Evaluation Phases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Bedfordshire</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Università degli Studi of Genova</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Örebro University, Sweden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Middlesex University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>SoftBank Robotics Europe</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Advinia Health Care limited</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Japan Advanced Institute of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nagoya University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chubu University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Bedfordshire</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The aim of this study is to conduct and evaluate a controlled experimental trial aimed at&#xD;
      exploring whether, to what extent and how a socially-assistive Pepper robot that operates on&#xD;
      a unique CARESSES cultural competence solution can produce better health and well-being&#xD;
      related outcomes among older adults residing in long stay care homes (and their informal&#xD;
      carers) compared to a control socially-assistive Pepper robot with an alternative CARESSES&#xD;
      solution, as well as care as usual.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of the &quot;Culture-Aware Robots and Environmental Sensor Systems for Elderly&#xD;
      Support' (CARESSES) project is to build culturally competent robots that are able to&#xD;
      re-configure their way of acting and speaking when offering a service to a person they are&#xD;
      assisting, and match his / her culture, customs and etiquette. This study will test and&#xD;
      evaluate robots that have been configured to provide a culturally-competent care to older&#xD;
      adults residing in care homes. It is hypothesised that by introducing robots, which are more&#xD;
      sensitive to the user's needs and able to adapt to his / her cultural background, the&#xD;
      CARESSES' innovative solution will offer a safe, reliable and intuitive system that fosters&#xD;
      independence and autonomy, improves quality of life of older adults, and also reduces&#xD;
      informal carer's burden. The methodology adopted to develop this culturally competent&#xD;
      solution is based on the principles of Transcultural Nursing, specifically on Hofstede's&#xD;
      Cultural dimensions theory (for describing general cultural characteristics at national&#xD;
      level) and on Papadopoulos, Tilki and Taylor's model of cultural competence.&#xD;
&#xD;
      At the heart of the CARESSES software is a cultural knowledge base (CKB) that stores all the&#xD;
      required information about the user and his / her cultural background. CKB was developed&#xD;
      using the guidelines provided by the experts in Transcultural Nursing, who identified through&#xD;
      field observations differences and similarities between individuals within three cultural&#xD;
      groups (i.e. White-English, Indian and Japanese) in order to avoid as much as possible&#xD;
      stereotyping and to provide suggestions regarding how likely culturally-specific behaviours&#xD;
      are valid for an individual belonging to the cultural group.&#xD;
&#xD;
      The study will employ a mixed method (qualitative and quantitative) single-blind, controlled&#xD;
      before-and-after experimental design with two testing sites (UK and Japan), in which&#xD;
      participants will either be purposefully allocated to an experimental arm (who will receive&#xD;
      and be assisted by the CARESSES robot), control arm 1 (who will receive and be assisted by&#xD;
      the control CARESSES robot) or control arm 2 (who will receive care as usual). Between and&#xD;
      within subjects comparisons will be used to evaluate whether and how the assistance of a&#xD;
      CARESSES Pepper robot improves health and well-being related outcomes among care home&#xD;
      residents and their informal carers. Eligible older adults from three cultural groups&#xD;
      (White-English, Indian and Japanese) will be recruited from the UK-based (White-English and&#xD;
      Indian cultural backgrounds only) and Japanese-based testing sites. Additionally, the&#xD;
      participants will be requested to nominate up to three informal carers of their choice who&#xD;
      will also be invited to take part in the study, but to a different degree. After the&#xD;
      recruitment, the participants from both sites will then be purposefully allocated to either&#xD;
      an experimental arm (UK site: n=10; Japan site: n=5) that will adopt the CARESSES robot, or&#xD;
      to a control arm 1 (UK site: n=10; Japan site: n=5) that will adopt the CARESSES control&#xD;
      robot, or to control arm 2 (UK site: n=10; Japan site n=5).&#xD;
&#xD;
      In the UK site, each of the arms will include five participants who primarily identify&#xD;
      themselves with the White-English culture, and five participants who primarily identify&#xD;
      themselves with the Indian culture. In the Japan site, three arms will only include&#xD;
      participants who primarily identify themselves with the Japanese culture. The participants&#xD;
      allocated to the control arm 2 will engage in testing first, followed by the control arm 1&#xD;
      and then the experimental arm. Testing will occur on two participants at any one time in the&#xD;
      UK site, and on one participant in the Japan site. Each participant will adopt a Pepper robot&#xD;
      over a period of two weeks.&#xD;
&#xD;
      Prior to commencing the full-scale study, a pre-trial feasibility pilot will be conducted&#xD;
      aimed at assessing the feasibility and acceptability of the screening, recruitment and&#xD;
      evaluation procedures, as well as identifying and tackling any technical issues associated&#xD;
      with the implementation of the CARESSES robot within a care home. One resident, who primarily&#xD;
      identifies himself / herself with the White-English culture and one informal carer will be&#xD;
      invited to take part in the pilot study. The evaluation procedure will take place in a&#xD;
      condensed format across one week (9 hours) rather than two weeks (18 hours) as during the&#xD;
      full-scale study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 15, 2019</start_date>
  <completion_date type="Anticipated">January 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>The researchers and technical staff supporting the experiments are unable to be blinded. Therefore, a single blind masking strategy will be used meaning that the participants and their carers (apart from the control arm 2) will be left unaware of what group they have been allocated to and what type of the CARESSES robot they will be interacting with.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Cultural Competence Assessment Tool -Robotics (CCATool-Robotics): change in perceptions of the robot's cultural competency when assistance provided with and without personalisation.</measure>
    <time_frame>Two sessions, approximately 15 minutes each in length</time_frame>
    <description>The measurement tool is an adaptation of the RCTSH Cultural Competence Assessment Tool (CCATool; Papadopoulos, Tilki, and Lees, 2004). The current tool is designed to measure older adults' perceptions of the CARESSES robot's cultural awareness, cultural knowledge, cultural sensitivity, and cultural competence. The tool comprises of 28 statements that participants use to rate their level of agreement with.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Short Form (36) Health Survey (SF-36</measure>
    <time_frame>Two sessions, approximately 20 minutes each in length</time_frame>
    <description>The SF-36v2 (Hays, Sherbourne, &amp; Mazel, 1993) is a multi-purpose, short-form health survey with 36 questions proven to be useful in surveys of general and specific populations, including older adults. It measures the following eight dimensions: general health, bodily pain, emotional role limitation, physical role limitation, mental health, vitality, physical functioning and social functioning. Each dimension score has values between 0 and 100, in which 0 means dead and 100 perfect health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Zarit Burden Inventory (ZBI)</measure>
    <time_frame>Two sessions, approximately 5 minutes each in length</time_frame>
    <description>A 22-item self-report inventory is aimed at evaluating subjective care burden among informal carers (Zarit, Reever, &amp; Bach-Peterson, 1980). Its validity and reliability have been widely established. The scale items examine burden associated with functional / behavioural impairments and care situations. Each item is scored on a 5-point Likert Scale ranging from &quot;never&quot; to &quot;nearly always present.&quot; A total score is obtained with higher scores indicting higher care burden among informal carers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short form University of California Los Angeles (UCLA) Loneliness Scale (ULS-8)</measure>
    <time_frame>Two sessions, approximately 8 minutes each in length</time_frame>
    <description>Loneliness will be measured using the Short-Form Measure of Loneliness (Hays &amp; DiMatteo, 1987). The scale is comprised of eight items to assess loneliness (&quot;I lack companionship&quot;, &quot;There is no one I can turn to&quot;, &quot;I am an outgoing person&quot;, &quot;I feel left out&quot;, &quot;I feel isolation from others&quot;, &quot;I can find companionship when I want it&quot;, &quot;I am unhappy being so withdrawn&quot;, &quot;People are around me but not with me&quot;) using a 4-point Likert scale with values ranging from &quot;never&quot; to &quot;always&quot;. To obtain a total score, all values are added up, and the higher scores are, the bigger feeling of loneliness may be presumed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire for user interface satisfaction (QUIS)</measure>
    <time_frame>One session, approximately 10 minutes in length</time_frame>
    <description>A measure of overall system satisfaction along six scales, and hierarchically organized measures of eleven specific interface factors (screen factors, terminology and system feedback, learning factors, system capabilities, technical manuals, on-line tutorials, multimedia, voice recognition, virtual environments, internet access, and software installation; Chin, Diehl, &amp; Norman, 1988). Each area measures the users' overall satisfaction with that facet of the interface, as well as the factors that make up that facet, on a 9-point scale. The questionnaire is designed to be configured according to the needs of each interface analysis by including only the sections that are of interest to the user. Taking into consideration the context of the current study, &quot;the software&quot; is replaced by &quot;the robot&quot; where required.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Negative attitudes towards robots scale (NARS)</measure>
    <time_frame>Two sessions, approximately 5 minutes each in length</time_frame>
    <description>This scale assesses participants' attitudes towards robots (Nomura, Kanda, Suzuki, &amp; Kato, 2004). NARS is comprised of 14 items scored on a 5-point Likert Scale (1= I completely disagree; 5=I completely agree), which in turn belong to three subscales: S1 measures &quot;situations of interaction with robots,&quot; S2 measures &quot;social inﬂuence of robots,&quot; and S3 measures &quot;emotions in interaction with robots&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Older adults' perceptions of the robot's cultural competence and overall experience</measure>
    <time_frame>One session, approximately 5 minutes each in length</time_frame>
    <description>Semi-structured interviews with older adults from the experimental group will be conducted to elicit their perceptions of the robot's cultural competence; acceptability of and satisfaction with the robot interactions; quality of service provided; and impact the robot had upon their health and well-being, independence and autonomy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Informal carers' experience of using the robot</measure>
    <time_frame>One session, approximately 20 minutes each in length</time_frame>
    <description>Semi-structured interviews with informal carers' from the experimental group will be conducted to receive their feedback on whether and how the robot reduced any feelings of carer burden and stress; their perceptions of whether and how the robot impacted upon the quality of life of both themselves and the resident; and perceptions regarding the robot's ease of use when interacting with it.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Aging</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will utilize the socially-assistive robot with a CARESSES cultural competence solution during 6 sessions (3 times per week, e.g., Monday, Wednesday, and Friday; for a total of 2 weeks) of 3 hours at a time.&#xD;
Baseline and follow-up assessments will be conducted prior to the beginning of the trials and shortly after the end of the last session accordingly.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control arm 1</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants will utilize the socially-assistive control robot with an alternative CARESSES solution during 6 sessions (3 times per week, e.g., Monday, Wednesday, and Friday; for a total of 2 weeks) of 3 hours at a time.&#xD;
Baseline and follow-up assessments will be conducted prior to the beginning of the trials and shortly after the end of the last session accordingly.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control arm 2</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will be receiving conventional human care with no robot intervention.&#xD;
Baseline assessments will be conducted as soon as participants are recruited and allocated to the study arm. Follow-up assessments will be conducted in two weeks after the baseline data collection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Socially-assistive Pepper robot with a CARESSES cultural competence solution</intervention_name>
    <description>Week 1. On the first day, training will be provided to the participants enabling them to familiarise themselves with the robot's functionalities. The robot will be culturally aware i.e., it will be aware of the participants' cultural background prior to the testing commencing. As such, it will pre-load the appropriate CKB and apply this during its time with the participants. During the next two sessions, the robot will interact and provide culturally-competent assistance, however, it will not learn and adjust to the participants' individual cultural values and preferences.&#xD;
Week 2. The participants will again utilize the robot for three days, but it now will learn from the responses it receives from them, consequently interacting in a culture-specific personalised way.</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Socially-assistive control Pepper robot with an alternative CARESSES solution</intervention_name>
    <description>Week 1. On the first day, training will be provided to the participants enabling them to familiarise themselves with the robot's functionalities. During the next two sessions, the CARESSES control robot will not be culturally aware: it will pre-load a generic and more limited CKB that is not tailored for anyone's cultural profile. It will also not learn and adjust to the participants' values and preferences.&#xD;
Week 2. Participants will again utilize the robot for three days, but the CARESSES control robot will now be configured to be able to learn and adapt to the individual's particular profile. This robot's learning will not include propagation: improving its cultural knowledge base in one area will not also automatically lead to knowledge improvements in other related areas. This robot will possess the same full suite of functions as the CARESSES robot although will be less likely to offer these in a culturally appropriate way.</description>
    <arm_group_label>Control arm 1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria (Older Adults):&#xD;
&#xD;
          -  Aged ≥ 65 years.&#xD;
&#xD;
          -  Reside in an eligible Advinia care home in the UK or within the HISUISUI facility in&#xD;
             Japan.&#xD;
&#xD;
          -  Reside in a single occupancy bedroom / bedroom area.&#xD;
&#xD;
          -  Identify themselves as primarily belonging to the White-English or Indian cultures (UK&#xD;
             site only), or Japanese culture (Japan site only).&#xD;
&#xD;
          -  Unlikely to express aggression towards themselves, the robot, and/or the researcher&#xD;
             (as assessed by the interRAI- Long Term Care Facility (LTCF) tool Aggressive Behaviour&#xD;
             Scale (ABS) &lt; 1).&#xD;
&#xD;
          -  Have the cognitive ability to participate in the study (as assessed by the&#xD;
             interRAI-LTCF tool Cognitive Performance Scale (CPS) ≤ 2).&#xD;
&#xD;
          -  Unlikely to fall ill and be hospitalized during study period (as assessed by the&#xD;
             FRAIL-NH scale ≤ 10)&#xD;
&#xD;
          -  Verbally able to communicate in and understand English (UK site only) or Japanese&#xD;
             (Japan site only).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Aged &lt; 65 years.&#xD;
&#xD;
          -  Reside in multiple-occupancy bedrooms (UK site only)&#xD;
&#xD;
          -  Do not identify themselves as primarily belonging to the Indian, White-English or&#xD;
             Japanese culture.&#xD;
&#xD;
          -  Likely to express aggression towards themselves the robot, and/or the researcher (as&#xD;
             assessed by the interRAI-LTCF tool ABS ≥ 1).&#xD;
&#xD;
          -  Do not have sufficient cognitive ability to participate in the study (as assessed by&#xD;
             the interRAI-LTCF tool CPS &gt; 2).&#xD;
&#xD;
          -  Likely to fall ill and be hospitalized during study period (as assessed by the&#xD;
             FRAIL-NH scale &gt; 10)&#xD;
&#xD;
          -  Not able to communicate in and understand English (UK site only) or Japanese (Japan&#xD;
             site only).&#xD;
&#xD;
        Inclusion criteria (Informal carers)&#xD;
&#xD;
          -  Aged ≥18 years.&#xD;
&#xD;
          -  Have visited the participant in the care home within the past 3 months.&#xD;
&#xD;
          -  Provide any type of informal help, care and/or support to the participant.&#xD;
&#xD;
          -  Are a relative, partner, friend or neighbour who has a significant personal&#xD;
             relationship with the participant.&#xD;
&#xD;
          -  Are not paid or officially employed to provide care to the participant.&#xD;
&#xD;
          -  Able to communicate in and understand English (UK site) or Japanese (Japanese site).&#xD;
&#xD;
        Exclusion criteria (Informal carers)&#xD;
&#xD;
          -  Aged &lt; 18 years.&#xD;
&#xD;
          -  Have not visited the participant in the care home within the past 3 months.&#xD;
&#xD;
          -  Not able to verbally communicate in and understand English (UK site only) or Japanese&#xD;
             (Japan site only).&#xD;
&#xD;
          -  Are formally paid to provide care to the participant.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Antonio Sgorbissa, ASSOC PROFESSOR</last_name>
    <role>Principal Investigator</role>
    <affiliation>Università di Genova</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chris Papadopoulos, Dr</last_name>
    <phone>+44 (0) 7719021766</phone>
    <email>Chris.Papadopoulos@beds.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Rosemary Davidson, Dr</last_name>
    <phone>+44 (0) 7966676974</phone>
    <email>rosemary.davidson@beds.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Bedfordshire</name>
      <address>
        <city>Luton</city>
        <zip>LU1 3JU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rosemary Davidson, Dr</last_name>
      <phone>+44 7966676974</phone>
      <email>rosemary.davidson@beds.ac.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>http://caressesrobot.org/en/</url>
    <description>Related Info</description>
  </link>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>October 9, 2019</last_update_submitted>
  <last_update_submitted_qc>October 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Bedfordshire</investigator_affiliation>
    <investigator_full_name>Dr Chris Papadopoulos</investigator_full_name>
    <investigator_title>Principal lecturer in Public Health</investigator_title>
  </responsible_party>
  <keyword>Aged</keyword>
  <keyword>Elders</keyword>
  <keyword>Robotics</keyword>
  <keyword>Cultural competence</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Loneliness</keyword>
  <keyword>Technology acceptance</keyword>
  <keyword>Social robotics</keyword>
  <keyword>Informal caregiver</keyword>
  <keyword>Homes for the aged</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pharmaceutical Solutions</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03756194
org study id: CARESSES No 737858
nct id: NCT03756194
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to conduct and evaluate a controlled experimental trial aimed at
      exploring whether, to what extent and how a socially-assistive Pepper robot that operates on
      a unique CARESSES cultural competence solution can produce better health and well-being
      related outcomes among older adults residing in long stay care homes (and their informal
      carers) compared to a control socially-assistive Pepper robot with an alternative CARESSES
      solution, as well as care as usual.
The objective of the "Culture-Aware Robots and Environmental Sensor Systems for Elderly
      Support' (CARESSES) project is to build culturally competent robots that are able to
      re-configure their way of acting and speaking when offering a service to a person they are
      assisting, and match his / her culture, customs and etiquette. This study will test and
      evaluate robots that have been configured to provide a culturally-competent care to older
      adults residing in care homes. It is hypothesised that by introducing robots, which are more
      sensitive to the user's needs and able to adapt to his / her cultural background, the
      CARESSES' innovative solution will offer a safe, reliable and intuitive system that fosters
      independence and autonomy, improves quality of life of older adults, and also reduces
      informal carer's burden. The methodology adopted to develop this culturally competent
      solution is based on the principles of Transcultural Nursing, specifically on Hofstede's
      Cultural dimensions theory (for describing general cultural characteristics at national
      level) and on Papadopoulos, Tilki and Taylor's model of cultural competence.

      At the heart of the CARESSES software is a cultural knowledge base (CKB) that stores all the
      required information about the user and his / her cultural background. CKB was developed
      using the guidelines provided by the experts in Transcultural Nursing, who identified through
      field observations differences and similarities between individuals within three cultural
      groups (i.e. White-English, Indian and Japanese) in order to avoid as much as possible
      stereotyping and to provide suggestions regarding how likely culturally-specific behaviours
      are valid for an individual belonging to the cultural group.

      The study will employ a mixed method (qualitative and quantitative) single-blind, controlled
      before-and-after experimental design with two testing sites (UK and Japan), in which
      participants will either be purposefully allocated to an experimental arm (who will receive
      and be assisted by the CARESSES robot), control arm 1 (who will receive and be assisted by
      the control CARESSES robot) or control arm 2 (who will receive care as usual). Between and
      within subjects comparisons will be used to evaluate whether and how the assistance of a
      CARESSES Pepper robot improves health and well-being related outcomes among care home
      residents and their informal carers. Eligible older adults from three cultural groups
      (White-English, Indian and Japanese) will be recruited from the UK-based (White-English and
      Indian cultural backgrounds only) and Japanese-based testing sites. Additionally, the
      participants will be requested to nominate up to three informal carers of their choice who
      will also be invited to take part in the study, but to a different degree. After the
      recruitment, the participants from both sites will then be purposefully allocated to either
      an experimental arm (UK site: n=10; Japan site: n=5) that will adopt the CARESSES robot, or
      to a control arm 1 (UK site: n=10; Japan site: n=5) that will adopt the CARESSES control
      robot, or to control arm 2 (UK site: n=10; Japan site n=5).

      In the UK site, each of the arms will include five participants who primarily identify
      themselves with the White-English culture, and five participants who primarily identify
      themselves with the Indian culture. In the Japan site, three arms will only include
      participants who primarily identify themselves with the Japanese culture. The participants
      allocated to the control arm 2 will engage in testing first, followed by the control arm 1
      and then the experimental arm. Testing will occur on two participants at any one time in the
      UK site, and on one participant in the Japan site. Each participant will adopt a Pepper robot
      over a period of two weeks.

      Prior to commencing the full-scale study, a pre-trial feasibility pilot will be conducted
      aimed at assessing the feasibility and acceptability of the screening, recruitment and
      evaluation procedures, as well as identifying and tackling any technical issues associated
      with the implementation of the CARESSES robot within a care home. One resident, who primarily
      identifies himself / herself with the White-English culture and one informal carer will be
      invited to take part in the pilot study. The evaluation procedure will take place in a
      condensed format across one week (9 hours) rather than two weeks (18 hours) as during the
      full-scale study.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
masking description: The researchers and technical staff supporting the experiments are unable to be blinded. Therefore, a single blind masking strategy will be used meaning that the participants and their carers (apart from the control arm 2) will be left unaware of what group they have been allocated to and what type of the CARESSES robot they will be interacting with.
measure: Cultural Competence Assessment Tool -Robotics (CCATool-Robotics): change in perceptions of the robot's cultural competency when assistance provided with and without personalisation.
time frame: Two sessions, approximately 15 minutes each in length
description: The measurement tool is an adaptation of the RCTSH Cultural Competence Assessment Tool (CCATool; Papadopoulos, Tilki, and Lees, 2004). The current tool is designed to measure older adults' perceptions of the CARESSES robot's cultural awareness, cultural knowledge, cultural sensitivity, and cultural competence. The tool comprises of 28 statements that participants use to rate their level of agreement with.
measure: Short Form (36) Health Survey (SF-36
time frame: Two sessions, approximately 20 minutes each in length
description: The SF-36v2 (Hays, Sherbourne, & Mazel, 1993) is a multi-purpose, short-form health survey with 36 questions proven to be useful in surveys of general and specific populations, including older adults. It measures the following eight dimensions: general health, bodily pain, emotional role limitation, physical role limitation, mental health, vitality, physical functioning and social functioning. Each dimension score has values between 0 and 100, in which 0 means dead and 100 perfect health.
measure: The Zarit Burden Inventory (ZBI)
time frame: Two sessions, approximately 5 minutes each in length
description: A 22-item self-report inventory is aimed at evaluating subjective care burden among informal carers (Zarit, Reever, & Bach-Peterson, 1980). Its validity and reliability have been widely established. The scale items examine burden associated with functional / behavioural impairments and care situations. Each item is scored on a 5-point Likert Scale ranging from "never" to "nearly always present." A total score is obtained with higher scores indicting higher care burden among informal carers.
measure: Short form University of California Los Angeles (UCLA) Loneliness Scale (ULS-8)
time frame: Two sessions, approximately 8 minutes each in length
description: Loneliness will be measured using the Short-Form Measure of Loneliness (Hays & DiMatteo, 1987). The scale is comprised of eight items to assess loneliness ("I lack companionship", "There is no one I can turn to", "I am an outgoing person", "I feel left out", "I feel isolation from others", "I can find companionship when I want it", "I am unhappy being so withdrawn", "People are around me but not with me") using a 4-point Likert scale with values ranging from "never" to "always". To obtain a total score, all values are added up, and the higher scores are, the bigger feeling of loneliness may be presumed.
measure: Questionnaire for user interface satisfaction (QUIS)
time frame: One session, approximately 10 minutes in length
description: A measure of overall system satisfaction along six scales, and hierarchically organized measures of eleven specific interface factors (screen factors, terminology and system feedback, learning factors, system capabilities, technical manuals, on-line tutorials, multimedia, voice recognition, virtual environments, internet access, and software installation; Chin, Diehl, & Norman, 1988). Each area measures the users' overall satisfaction with that facet of the interface, as well as the factors that make up that facet, on a 9-point scale. The questionnaire is designed to be configured according to the needs of each interface analysis by including only the sections that are of interest to the user. Taking into consideration the context of the current study, "the software" is replaced by "the robot" where required.
measure: Negative attitudes towards robots scale (NARS)
time frame: Two sessions, approximately 5 minutes each in length
description: This scale assesses participants' attitudes towards robots (Nomura, Kanda, Suzuki, & Kato, 2004). NARS is comprised of 14 items scored on a 5-point Likert Scale (1= I completely disagree; 5=I completely agree), which in turn belong to three subscales: S1 measures "situations of interaction with robots," S2 measures "social inﬂuence of robots," and S3 measures "emotions in interaction with robots".
measure: Older adults' perceptions of the robot's cultural competence and overall experience
time frame: One session, approximately 5 minutes each in length
description: Semi-structured interviews with older adults from the experimental group will be conducted to elicit their perceptions of the robot's cultural competence; acceptability of and satisfaction with the robot interactions; quality of service provided; and impact the robot had upon their health and well-being, independence and autonomy.
measure: Informal carers' experience of using the robot
time frame: One session, approximately 20 minutes each in length
description: Semi-structured interviews with informal carers' from the experimental group will be conducted to receive their feedback on whether and how the robot reduced any feelings of carer burden and stress; their perceptions of whether and how the robot impacted upon the quality of life of both themselves and the resident; and perceptions regarding the robot's ease of use when interacting with it.
arm group label: Experimental
arm group type: Experimental
description: Participants will utilize the socially-assistive robot with a CARESSES cultural competence solution during 6 sessions (3 times per week, e.g., Monday, Wednesday, and Friday; for a total of 2 weeks) of 3 hours at a time.
Baseline and follow-up assessments will be conducted prior to the beginning of the trials and shortly after the end of the last session accordingly.
arm group label: Control arm 1
arm group type: Other
description: Participants will utilize the socially-assistive control robot with an alternative CARESSES solution during 6 sessions (3 times per week, e.g., Monday, Wednesday, and Friday; for a total of 2 weeks) of 3 hours at a time.
Baseline and follow-up assessments will be conducted prior to the beginning of the trials and shortly after the end of the last session accordingly.
arm group label: Control arm 2
arm group type: No Intervention
description: Participants will be receiving conventional human care with no robot intervention.
Baseline assessments will be conducted as soon as participants are recruited and allocated to the study arm. Follow-up assessments will be conducted in two weeks after the baseline data collection.
intervention type: Device
intervention name: Socially-assistive Pepper robot with a CARESSES cultural competence solution
description: Week 1. On the first day, training will be provided to the participants enabling them to familiarise themselves with the robot's functionalities. The robot will be culturally aware i.e., it will be aware of the participants' cultural background prior to the testing commencing. As such, it will pre-load the appropriate CKB and apply this during its time with the participants. During the next two sessions, the robot will interact and provide culturally-competent assistance, however, it will not learn and adjust to the participants' individual cultural values and preferences.
Week 2. The participants will again utilize the robot for three days, but it now will learn from the responses it receives from them, consequently interacting in a culture-specific personalised way.
arm group label: Experimental
intervention type: Device
intervention name: Socially-assistive control Pepper robot with an alternative CARESSES solution
description: Week 1. On the first day, training will be provided to the participants enabling them to familiarise themselves with the robot's functionalities. During the next two sessions, the CARESSES control robot will not be culturally aware: it will pre-load a generic and more limited CKB that is not tailored for anyone's cultural profile. It will also not learn and adjust to the participants' values and preferences.
Week 2. Participants will again utilize the robot for three days, but the CARESSES control robot will now be configured to be able to learn and adapt to the individual's particular profile. This robot's learning will not include propagation: improving its cultural knowledge base in one area will not also automatically lead to knowledge improvements in other related areas. This robot will possess the same full suite of functions as the CARESSES robot although will be less likely to offer these in a culturally appropriate way.
arm group label: Control arm 1
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Antonio Sgorbissa, ASSOC PROFESSOR
role: Principal Investigator
affiliation: Università di Genova
last name: Chris Papadopoulos, Dr
phone: +44 (0) 7719021766
email: Chris.Papadopoulos@beds.ac.uk
last name: Rosemary Davidson, Dr
phone: +44 (0) 7966676974
email: rosemary.davidson@beds.ac.uk
facility: 
status: Recruiting
contact: 
country: United Kingdom
url: http://caressesrobot.org/en/
description: Related Info
responsible party type: Principal Investigator
investigator affiliation: University of Bedfordshire
investigator full name: Dr Chris Papadopoulos
investigator title: Principal lecturer in Public Health
mesh term: Pharmaceutical Solutions
sharing ipd: No