CARESSES Testing and Evaluation Phases

NCT03756194 | Unknown DMC

• 1 other identifier: CARESSES No 737858
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Keywords

Aged; Elders; Robotics; Cultural competence; Quality of life; Loneliness; Technology acceptance; Social robotics; Informal caregiver; Homes for the aged

Outcome Measures

Primary Outcomes (1)

• Cultural Competence Assessment Tool -Robotics (CCATool-Robotics): change in perceptions of the robot's cultural competency when assistance provided with and without personalisation.

  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.

  Two sessions, approximately 15 minutes each in length

Secondary Outcomes (7)

• Short Form (36) Health Survey (SF-36

  Two sessions, approximately 20 minutes each in length

• The Zarit Burden Inventory (ZBI)

  Two sessions, approximately 5 minutes each in length

• Short form University of California Los Angeles (UCLA) Loneliness Scale (ULS-8)

  Two sessions, approximately 8 minutes each in length

• Questionnaire for user interface satisfaction (QUIS)

  One session, approximately 10 minutes in length

• Negative attitudes towards robots scale (NARS)

  Two sessions, approximately 5 minutes each in length

Study Arms (3)

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

Control arm 1

OTHER

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

Control arm 2

NO INTERVENTION

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.

Interventions

Socially-assistive Pepper robot with a CARESSES cultural competence solution DEVICE

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.

Experimental

Socially-assistive control Pepper robot with an alternative CARESSES solution DEVICE

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.

Control arm 1

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).
• 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).
• Aged \< 18 years.
• Have not visited the participant in the care home within the past 3 months.

Sponsors & Collaborators

• University of Bedfordshire: lead
• Università degli Studi of Genova: collaborator
• Örebro University, Sweden: collaborator
• Middlesex University: collaborator
• SoftBank Robotics Europe: collaborator
• Advinia Health Care limited: collaborator
• Japan Advanced Institute of Science and Technology: collaborator
• Nagoya University: collaborator
• Chubu University: collaborator

Study Sites (1)

University of Bedfordshire

Luton, LU1 3JU, United Kingdom

RECRUITING

Related Publications (1)

• Papadopoulos C, Hill T, Battistuzzi L, Castro N, Nigath A, Randhawa G, Merton L, Kanoria S, Kamide H, Chong NY, Hewson D, Davidson R, Sgorbissa A. The CARESSES study protocol: testing and evaluating culturally competent socially assistive robots among older adults residing in long term care homes through a controlled experimental trial. Arch Public Health. 2020 Mar 20;78:26. doi: 10.1186/s13690-020-00409-y. eCollection 2020.

  PMID: 32206312 DERIVED

Related Links

• Related Info

Study Officials

• Antonio Sgorbissa, ASSOC PROFESSOR

  Università di Genova

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chris Papadopoulos, Dr

CONTACT

+44 (0) 7719021766; Chris.Papadopoulos@beds.ac.uk

Rosemary Davidson, Dr

CONTACT

+44 (0) 7966676974; rosemary.davidson@beds.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal lecturer in Public Health

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: November 28, 2018
• Study Start: February 15, 2019
• Primary Completion: October 31, 2019
• Study Completion: January 31, 2020
• Last Updated: October 14, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)