Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

CARESSES Testing and Evaluation Phases (CARESSES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03756194
Recruitment Status : Recruiting
First Posted : November 28, 2018
Last Update Posted : October 14, 2019
Sponsor:
Collaborators:
Università degli Studi of Genova
Örebro University
Middlesex University
SoftBank Robotics Europe
Advinia Health Care limited
Japan Advanced Institute of Science and Technology
Nagoya University
Chubu University
Information provided by (Responsible Party):
Dr Chris Papadopoulos, University of Bedfordshire

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Aging Device: Socially-assistive Pepper robot with a CARESSES cultural competence solution Device: Socially-assistive control Pepper robot with an alternative CARESSES solution Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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.
Primary Purpose: Other
Official Title: 'Culture-Aware Robots and Environmental Sensor Systems for Elderly Support' (CARESSES) - Testing and Evaluation Phases
Actual Study Start Date : February 15, 2019
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : January 31, 2020

Arm Intervention/treatment
Experimental: Experimental

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.

Device: Socially-assistive Pepper robot with a CARESSES cultural competence solution

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.


Control arm 1

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.

Device: Socially-assistive control Pepper robot with an alternative CARESSES solution

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.


No Intervention: Control arm 2

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.




Primary Outcome Measures :
  1. 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 ]
    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.


Secondary Outcome Measures :
  1. Short Form (36) Health Survey (SF-36 [ Time Frame: Two sessions, approximately 20 minutes each in length ]
    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.

  2. The Zarit Burden Inventory (ZBI) [ Time Frame: Two sessions, approximately 5 minutes each in length ]
    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.

  3. Short form University of California Los Angeles (UCLA) Loneliness Scale (ULS-8) [ Time Frame: Two sessions, approximately 8 minutes each in length ]
    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.

  4. Questionnaire for user interface satisfaction (QUIS) [ Time Frame: One session, approximately 10 minutes in length ]
    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.

  5. Negative attitudes towards robots scale (NARS) [ Time Frame: Two sessions, approximately 5 minutes each in length ]
    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".

  6. Older adults' perceptions of the robot's cultural competence and overall experience [ Time Frame: One session, approximately 5 minutes each in length ]
    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.

  7. Informal carers' experience of using the robot [ Time Frame: One session, approximately 20 minutes each in length ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria (Older Adults):

  • Aged ≥ 65 years.
  • Reside in an eligible Advinia care home in the UK or within the HISUISUI facility in Japan.
  • Reside in a single occupancy bedroom / bedroom area.
  • Identify themselves as primarily belonging to the White-English or Indian cultures (UK site only), or Japanese culture (Japan site only).
  • Unlikely to express aggression towards themselves, the robot, and/or the researcher (as assessed by the interRAI- Long Term Care Facility (LTCF) tool Aggressive Behaviour Scale (ABS) < 1).
  • Have the cognitive ability to participate in the study (as assessed by the interRAI-LTCF tool Cognitive Performance Scale (CPS) ≤ 2).
  • Unlikely to fall ill and be hospitalized during study period (as assessed by the FRAIL-NH scale ≤ 10)
  • Verbally able to communicate in and understand English (UK site only) or Japanese (Japan site only).

Exclusion Criteria:

  • Aged < 65 years.
  • Reside in multiple-occupancy bedrooms (UK site only)
  • Do not identify themselves as primarily belonging to the Indian, White-English or Japanese culture.
  • Likely to express aggression towards themselves the robot, and/or the researcher (as assessed by the interRAI-LTCF tool ABS ≥ 1).
  • Do not have sufficient cognitive ability to participate in the study (as assessed by the interRAI-LTCF tool CPS > 2).
  • Likely to fall ill and be hospitalized during study period (as assessed by the FRAIL-NH scale > 10)
  • Not able to communicate in and understand English (UK site only) or Japanese (Japan site only).

Inclusion criteria (Informal carers)

  • Aged ≥18 years.
  • Have visited the participant in the care home within the past 3 months.
  • Provide any type of informal help, care and/or support to the participant.
  • Are a relative, partner, friend or neighbour who has a significant personal relationship with the participant.
  • Are not paid or officially employed to provide care to the participant.
  • Able to communicate in and understand English (UK site) or Japanese (Japanese site).

Exclusion criteria (Informal carers)

  • Aged < 18 years.
  • Have not visited the participant in the care home within the past 3 months.
  • Not able to verbally communicate in and understand English (UK site only) or Japanese (Japan site only).
  • Are formally paid to provide care to the participant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03756194


Contacts
Layout table for location contacts
Contact: Chris Papadopoulos, Dr +44 (0) 7719021766 Chris.Papadopoulos@beds.ac.uk
Contact: Rosemary Davidson, Dr +44 (0) 7966676974 rosemary.davidson@beds.ac.uk

Locations
Layout table for location information
United Kingdom
University of Bedfordshire Recruiting
Luton, United Kingdom, LU1 3JU
Contact: Rosemary Davidson, Dr    +44 7966676974    rosemary.davidson@beds.ac.uk   
Sponsors and Collaborators
University of Bedfordshire
Università degli Studi of Genova
Örebro University
Middlesex University
SoftBank Robotics Europe
Advinia Health Care limited
Japan Advanced Institute of Science and Technology
Nagoya University
Chubu University
Investigators
Layout table for investigator information
Principal Investigator: Antonio Sgorbissa, ASSOC PROFESSOR Università di Genova

Additional Information:
Layout table for additonal information
Responsible Party: Dr Chris Papadopoulos, Principal lecturer in Public Health, University of Bedfordshire
ClinicalTrials.gov Identifier: NCT03756194     History of Changes
Other Study ID Numbers: CARESSES No 737858
First Posted: November 28, 2018    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Chris Papadopoulos, University of Bedfordshire:
Aged
Elders
Robotics
Cultural competence
Quality of life
Loneliness
Technology acceptance
Social robotics
Informal caregiver
Homes for the aged
Additional relevant MeSH terms:
Layout table for MeSH terms
Pharmaceutical Solutions