- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04168463
Exploring Use of Companion Robot Pets for Older Adults in Care Homes
Exploring Use of Companion Robot Pets for Older Adults in Care Homes, an 8-month Stepped-wedge, Cluster Randomised Control Trial.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Devon
-
Plymouth, Devon, United Kingdom, PL4 8AA
- University of Plymouth
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Immediate Intervention
This cluster of four homes will receive robot animals immediately at commencement of the eight month trial.
|
Intervention will include the opportunity to interact with the Joy for All robot animals.
Other Names:
|
Other: Delayed Intervention
This cluster of four homes will receive robot animals four months after commencement of the 8 month trial.
The four months without robots will serve as a control period.
|
Intervention will include the opportunity to interact with the Joy for All robot animals.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neuropsychiatric Inventory (Nursing Home Version) (Cummings, 1994)
Time Frame: Measured at baseline, 4 months and 8 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Challenging Behaviour Scale (Moniz-Cook et al., 2001)
Time Frame: Measured at baseline, 4 months and 8 months
|
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
|
Campaign to End Loneliness Measurement Tool (3-item) (Campaign to End Loneliness, n.d.)
Time Frame: Measured at baseline, 4 months and 8 months
|
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
|
Holden Communication Scale (Strøm et al., 2016)
Time Frame: Measured at baseline, 4 months and 8 months
|
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
|
Medication Use Review
Time Frame: 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
|
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
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1:1 Care Applications
Time Frame: 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
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Will assess any changes in number of 1:1 care applications for each care home resident
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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
|
Qualitative Impact Review
Time Frame: 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
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hannah L Bradwell, MSc, PhD Student, School of Nursing and Midwifery, University of Plymouth
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 268571
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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