CARESSES Testing and Evaluation Phases (NCT03756194) | Clinical Trial Compass
UnknownNot Applicable
CARESSES Testing and Evaluation Phases
United Kingdom90 participantsStarted 2019-02-15
Plain-language 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.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cultural Competence Assessment Tool -Robotics (CCATool-Robotics): change in perceptions of the robot's cultural competency when assistance provided with and without personalisation.
Timeframe: Two sessions, approximately 15 minutes each in length