Exploring Use of Companion Robot Pets for Older Adults in Care Homes
Primary Purpose
Aging, Dementia, Neuropsychiatric Symptoms
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Two Joy for All robots (one cat and one dog)
Sponsored by
About this trial
This is an interventional supportive care trial for Aging focused on measuring Dementia, Social robots, Companion robots, Robot pets, Wellbeing, Older adults, Long-term care, Residential care
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.
Sites / Locations
- University of Plymouth
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Immediate Intervention
Delayed Intervention
Arm Description
This cluster of four homes will receive robot animals immediately at commencement of the eight month trial.
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.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
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.
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.
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.
1:1 Care Applications
Will assess any changes in number of 1:1 care applications for each care home resident
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
Full Information
NCT ID
NCT04168463
First Posted
November 15, 2019
Last Updated
February 20, 2021
Sponsor
University of Plymouth
1. Study Identification
Unique Protocol Identification Number
NCT04168463
Brief Title
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
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
January 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Plymouth
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Dementia, Neuropsychiatric Symptoms, Wellbeing
Keywords
Dementia, Social robots, Companion robots, Robot pets, Wellbeing, Older adults, Long-term care, Residential care
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Stepped-wedge, cluster randomised control trial
Masking
None (Open Label)
Masking Description
N/A not possible
Allocation
Randomized
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Immediate Intervention
Arm Type
Experimental
Arm Description
This cluster of four homes will receive robot animals immediately at commencement of the eight month trial.
Arm Title
Delayed Intervention
Arm Type
Other
Arm Description
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 Type
Device
Intervention Name(s)
Two Joy for All robots (one cat and one dog)
Other Intervention Name(s)
Robot pets, Companion robots
Intervention Description
Intervention will include the opportunity to interact with the Joy for All robot animals.
Primary Outcome Measure Information:
Title
Neuropsychiatric Inventory (Nursing Home Version) (Cummings, 1994)
Description
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)
Time Frame
Measured at baseline, 4 months and 8 months
Secondary Outcome Measure Information:
Title
Challenging Behaviour Scale (Moniz-Cook et al., 2001)
Description
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.
Time Frame
Measured at baseline, 4 months and 8 months
Title
Campaign to End Loneliness Measurement Tool (3-item) (Campaign to End Loneliness, n.d.)
Description
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.
Time Frame
Measured at baseline, 4 months and 8 months
Title
Holden Communication Scale (Strøm et al., 2016)
Description
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.
Time Frame
Measured at baseline, 4 months and 8 months
Title
Medication Use Review
Description
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.
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
Title
1:1 Care Applications
Description
Will assess any changes in number of 1:1 care applications for each care home resident
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
Title
Qualitative Impact Review
Description
Review of diaries, staff interviews and staff summative review will allow qualitative assessment of impact that may have been missed on selected quantitative scales
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hannah L Bradwell, MSc
Organizational Affiliation
PhD Student, School of Nursing and Midwifery, University of Plymouth
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Plymouth
City
Plymouth
State/Province
Devon
ZIP/Postal Code
PL4 8AA
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
11593958
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.
Results Reference
background
PubMed Identifier
27965255
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.
Results Reference
background
PubMed Identifier
35830959
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.
Results Reference
derived
Links:
URL
http://www.dementiamanagementstrategy.com/File.axd?id=c9f7405f-3596-4f5f-9f8d-f322e5188678
Description
Cummings, 1994
URL
https://www.campaigntoendloneliness.org/wp-content/uploads/Loneliness-Measurement-Guidance1-1.pdf
Description
Campaign to End Loneliness (n.d.)
URL
https://mafiadoc.com/the-holden-communication-scale-hcs_5a0b796c1723dd1abb6a85cb.html
Description
Holden Communication Scale
Learn more about this trial
Exploring Use of Companion Robot Pets for Older Adults in Care Homes
We'll reach out to this number within 24 hrs