Clinical trial NCT04168463: Exploring Use of Companion Robot Pets for Older Adults in Care Homes
Official title: Exploring Use of Companion Robot Pets for Older Adults in Care Homes, an 8-month Stepped-wedge, Cluster Randomised Control Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Dementia
Neuropsychiatric Symptoms
Wellbeing
Keywords: Dementia
Social robots
Companion robots
Robot pets
Wellbeing
Older adults
Long-term care
Residential care
Lead sponsor: University of Plymouth
Sponsor class: OTHER
First posted: 2019-11-19
Enrollment: 83
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Stepped-wedge, cluster randomised control trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will assess the use and impact of the affordable 'Joy for All' robot pets for older people with and without dementia living in the care homes in South West England.

Robot pets such as Paro have shown potential in improving wellbeing (including reduced agitation, loneliness, medication use, anxiety and depression), however previous work conducted by the investigators suggests Paro is less acceptable to older adults than alternative devices; the Joy for All cat and dog. Paro is also much more expensive (£5000 compared to £100) limiting its use within the real world, and limiting the number of people able to benefit.

The investigators therefore wish to explore the potential of these more affordable robots in achieving wellbeing benefits.

Detailed description: This study will be an eight month stepped-wedge, cluster randomised control trial exploring the use and impact of 'Joy for All' robot pets with older people living in care homes in South West England. Participants will include individuals with and without dementia.

The study aims to:

* See if affordable robot pets lead to improved wellbeing and are robust and engaging over 4-8 months in care homes and nursing homes.
* Identify under what circumstances, for which care home residents, and with what impact the robot pets are used.

The wellbeing outcomes to be explored include; neuropsychiatric symptoms, challenging behaviour, communication and loneliness.

Additional outcomes include monitoring of medication use, 1:1 care applications, and maintenance of a usage chart.

Qualitative data will also be collected through reflective diaries maintained by care staff, and interviews following completion of the study.

The study will include residents of eight care homes, which will be stratified into two clusters based on size and dementia service. The two clusters will then be randomised to immediate start (and receive robot animals immediately), or delayed start (and receive robot animals after four months). This provides a period of control. The sample size is primarily informed by feasibility, and the number of residents in each home likely to participate. In total there are approximately 190 residents of which the investigators estimate 100 across the 8 homes will give consent and interact with the robots. If 70% residents (across both arms and over the whole study) benefit from interacting with the robots the 95% confidence interval is 61-79%. This is of sufficient precision.

Measures will be completed at baseline, 4 months and 8 months. Interviews will be conducted at 8 months, and analysed alongside reflective diary entries.

This study should provide understanding of the potential for these more affordable robot pets in improving wellbeing for older people, and insight into their use and implementation.

Eligibility criteria: Inclusion Criteria:

* Any resident at a collaborating care home or nursing home that has consent to participate.

Exclusion Criteria:

* Any resident at a collaborating home without consent to participate.

Primary outcomes:
measure: Neuropsychiatric Inventory (Nursing Home Version) (Cummings, 1994)
timeFrame: Measured at baseline, 4 months and 8 months
Secondary outcomes:
measure: Challenging Behaviour Scale (Moniz-Cook et al., 2001)
timeFrame: Measured at baseline, 4 months and 8 months
measure: Campaign to End Loneliness Measurement Tool (3-item) (Campaign to End Loneliness, n.d.)
timeFrame: Measured at baseline, 4 months and 8 months
measure: Holden Communication Scale (Strøm et al., 2016)
timeFrame: Measured at baseline, 4 months and 8 months
measure: Medication Use Review
timeFrame: Will be reviewed for the 4 weeks prior to study commencement, 4 weeks prior to 4 month post study commencement and the 4 weeks prior to study completion at 8 months
measure: 1:1 Care Applications
timeFrame: Will be reviewed for the 4 weeks prior to study commencement, 4 weeks prior to 4 month post study commencement and the 4 weeks prior to study completion at 8 months
measure: Qualitative Impact Review
timeFrame: Dairies will be maintained during intervention phases (8 months for cluster 1, 4 months for cluster 2), interviews and summative review will be conducted at 8 months
Other outcomes:
Locations:
city: Plymouth
country: United Kingdom
facility: University of Plymouth
state: Devon
Study officials:
affiliation: PhD Student, School of Nursing and Midwifery, University of Plymouth
name: Hannah L Bradwell, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moniz-Cook E, Woods R, Gardiner E, Silver M, Agar S. The Challenging Behaviour Scale (CBS): development of a scale for staff caring for older people in residential and nursing homes. Br J Clin Psychol. 2001 Sep;40(3):309-22. doi: 10.1348/014466501163715.
citation: Strom BS, Engedal K, Saltyte Benth J, Grov EK. Psychometric evaluation of the Holden Communication Scale (HCS) for persons with dementia. BMJ Open. 2016 Dec 13;6(12):e013447. doi: 10.1136/bmjopen-2016-013447.
citation: Bradwell H, Edwards KJ, Winnington R, Thill S, Allgar V, Jones RB. Implementing Affordable Socially Assistive Pet Robots in Care Homes Before and During the COVID-19 Pandemic: Stratified Cluster Randomized Controlled Trial and Mixed Methods Study. JMIR Aging. 2022 Aug 24;5(3):e38864. doi: 10.2196/38864.