Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT03756194
Eligibility 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT03756194
Study Brief:
Protocol Section:
NCT03756194