Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000500459
Ethics application status
Approved
Date submitted
2/05/2025
Date registered
22/05/2025
Date last updated
15/06/2025
Date data sharing statement initially provided
22/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Artificial Intelligence (AI) skilled companion for people in assisted living facilities: Pilot study
Scientific title
The effect of an AI skilled companion on loneliness for people in assisted living facilities: Pilot study
Secondary ID [1] 314352 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild cognitive impairment 337333 0
Anxiety 337585 0
Depression 337586 0
Dementia 337587 0
Condition category
Condition code
Neurological 333717 333717 0 0
Dementias
Neurological 333718 333718 0 0
Other neurological disorders
Mental Health 333719 333719 0 0
Anxiety
Mental Health 333720 333720 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will interact with an agentic AI companion. They will be provided supervised access at least twice a week for 15 minutes during the 4 week intervention. They will also have unsupervised access available during the intervention on-demand. The participants will access a purpose-built AI companion access on a touch-screen tablet and also on a large human-sized screen in a common area. The participants will have conversations with the AI companion, which will reply based on its programming in a naturalistic manner (not pre-scripted responses). The AI companion has been previously co-designed with people with dementia and is called 'Viv'. There is no maximum number of times the participant can access the companion per week.
Intervention code [1] 330964 0
Treatment: Other
Intervention code [2] 331137 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341314 0
Loneliness
Assessment method [1] 341314 0
UCLA Loneliness scale
Timepoint [1] 341314 0
Baseline and 1 week post-completion of intervention
Secondary outcome [1] 447095 0
Social networks
Assessment method [1] 447095 0
Lubben Social Network Scale (Lubben et al. 2006)
Timepoint [1] 447095 0
Baseline and 1 week post-completion of intervention
Secondary outcome [2] 447096 0
Quality of life
Assessment method [2] 447096 0
Assessment of Quality of Life-6D (AQOL-6D, Richard et al. 2012)- relationship and mental well-being subscales (participant version)
Timepoint [2] 447096 0
Baseline and 1 week post-completion of intervention
Secondary outcome [3] 447097 0
Depression
Assessment method [3] 447097 0
Geriatric Depression Scale 15 item version (D’Ath et al. 1994)
Timepoint [3] 447097 0
Baseline and 1 week post-completion of intervention
Secondary outcome [4] 447098 0
Anxiety
Assessment method [4] 447098 0
Goldberg Anxiety Scale (Goldberg et al. 1987)
Timepoint [4] 447098 0
Baseline and 1 week post-completion of intervention
Secondary outcome [5] 447099 0
Changed behaviours
Assessment method [5] 447099 0
Neuropsychiatric Inventory (NPI, Cummings, 1994) (care partner- optional)
Timepoint [5] 447099 0
Baseline and 1 week post-completion of intervention
Secondary outcome [6] 447697 0
Quality of life (care partner- optional)
Assessment method [6] 447697 0
Quality of Life-Alzheimer's Disease Scale (QoL-AD; Logsdon et al. 1999) (care partner version- optional).
Timepoint [6] 447697 0
Baseline and 1 week post-completion of intervention

Eligibility
Key inclusion criteria
People in assisted living facilities:
Aged 55 or older
Living in an assisted living facility
Cognitively healthy, or living with mild cognitive impairment, or mild to moderate dementia

Study partner
Inclusion criteria include:
Staff member at an assisted living facility or care partner supporting a person participating in the study.
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People in assisted living facilities:
Not able to give informed consent or have family member or guardian provide consent

Study partner:
N/A

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 318871 0
University
Name [1] 318871 0
UNSW Sydney (in-kind support)
Country [1] 318871 0
Australia
Primary sponsor type
University
Name
UNSW Sydney
Country
Australia
Secondary sponsor category [1] 321332 0
None
Name [1] 321332 0
Country [1] 321332 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317484 0
The University of New South Wales Committee C
Ethics committee address [1] 317484 0
Ethics committee country [1] 317484 0
Australia
Date submitted for ethics approval [1] 317484 0
10/04/2025
Approval date [1] 317484 0
02/06/2025
Ethics approval number [1] 317484 0
iRECS8662

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 141202 0
Dr Suraj Samtani
Address 141202 0
Centre for Healthy Brain Ageing (CHeBA), School of Clinical Medicine, Discipline of Psychiatry & Mental Health, UNSW Medicine and Health, Level 3, AGSM (G27), Gate 11, Botany Street UNSW SYDNEY 2052 AUSTRALIA
Country 141202 0
Australia
Phone 141202 0
+61 293480170
Email 141202 0
s.samtani@unsw.edu.au
Contact person for public queries
Name 141203 0
Suraj Samtani
Address 141203 0
Centre for Healthy Brain Ageing (CHeBA), School of Clinical Medicine, Discipline of Psychiatry & Mental Health, UNSW Medicine and Health, Level 3, AGSM (G27), Gate 11, Botany Street UNSW SYDNEY 2052 AUSTRALIA
Country 141203 0
Australia
Phone 141203 0
+61 293480170
Email 141203 0
s.samtani@unsw.edu.au
Contact person for scientific queries
Name 141204 0
Suraj Samtani
Address 141204 0
Centre for Healthy Brain Ageing (CHeBA), School of Clinical Medicine, Discipline of Psychiatry & Mental Health, UNSW Medicine and Health, Level 3, AGSM (G27), Gate 11, Botany Street UNSW SYDNEY 2052 AUSTRALIA
Country 141204 0
Australia
Phone 141204 0
+61 293480170
Email 141204 0
s.samtani@unsw.edu.au

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: The ethics application states that data will not be shared for secondary research purposes



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol  s.samtani@unsw.edu.au
Informed consent form  s.samtani@unsw.edu.au
Ethical approval  s.samtani@unsw.edu.au iRECS8662- ethics approval 20250602.pdf


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.