Exploring Use of Companion Robot Pets for Older Adults in Care Homes

Aging Clinical Trial

Official title:

Exploring Use of Companion Robot Pets for Older Adults in Care Homes, an 8-month Stepped-wedge, Cluster Randomised Control Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04168463
• Other study ID #: 268571
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: January 1, 2021

Study information

• Verified date: February 2021
• Source: University of Plymouth
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: January 1, 2021
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Dementia
• Neuropsychiatric Symptoms
• Wellbeing

Intervention

Device:
• Two Joy for All robots (one cat and one dog)
Intervention will include the opportunity to interact with the Joy for All robot animals.

Locations

Country	Name	City	State
United Kingdom	University of Plymouth	Plymouth	Devon

Sponsors (1)

Lead Sponsor	Collaborator
University of Plymouth

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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. — View Citation

Strøm BS, Engedal K, Šaltyte 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuropsychiatric Inventory (Nursing Home Version) (Cummings, 1994)	Will be used to assess any changes in neuropsychiatric symptoms of care home residents. For each domain, there are four scores; frequency (0-4, with higher scores being most frequent), severity (0-3, with higher scores being most severe), total score (frequency x severity), and caregiver distress (0-5, higher scores signal more distress)	Measured at baseline, 4 months and 8 months
Secondary	Challenging Behaviour Scale (Moniz-Cook et al., 2001)	Will be used to assess any changes in challenging behaviour exhibited by care home residents. Scores range from 0-400, with higher scores indicating more challenging behaviours.	Measured at baseline, 4 months and 8 months
Secondary	Campaign to End Loneliness Measurement Tool (3-item) (Campaign to End Loneliness, n.d.)	Will be used to assess any changes in feelings of loneliness among care home residents. This outcome is measures with 3-items, scores range from 0-12, with higher scores indicating most loneliness.	Measured at baseline, 4 months and 8 months
Secondary	Holden Communication Scale (Strøm et al., 2016)	Will be used to assess any changes in communication of care home residents. Scores range from 0-48, with higher scores indicating more communication difficulties.	Measured at baseline, 4 months and 8 months
Secondary	Medication Use Review	Medication charts will be reviewed to assess any changes in medication use, particularly anti-depressant or anti-psychotic or 'pro re nata' or PRN medications to alleviate mood or distress.	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
Secondary	1:1 Care Applications	Will assess any changes in number of 1:1 care applications for each care home resident	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
Secondary	Qualitative Impact Review	Review of diaries, staff interviews and staff summative review will allow qualitative assessment of impact that may have been missed on selected quantitative scales	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

External Links

•   Campaign to End Loneliness (n.d.)
•   Cummings, 1994
•   Holden Communication Scale