AgingNCT04168463
Exploring Use of Companion Robot Pets for Older Adults in Care Homes
A study testing Two Joy for All robots (one cat and one dog) in people with Aging and Dementia, run by University of Plymouth at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Dementia, Neuropsychiatric Symptoms
- What is being tested?
- Two Joy for All robots (one cat and one dog)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2020to 1 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Any resident at a collaborating care home or nursing home that has consent to participate.
Who cannot join
- Any resident at a collaborating home without consent to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Aging, Dementia, Neuropsychiatric Symptoms, Wellbeing
- Being tested
- Two Joy for All robots (one cat and one dog)
- Keywords
- Dementia, Social robots, Companion robots, Robot pets, Wellbeing, Older adults, Long-term care, Residential care
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two Joy for All robots (one cat and one dog)Device
Also called Robot pets, Companion robots
Intervention will include the opportunity to interact with the Joy for All robot animals.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Intervention | Experimental | This cluster of four homes will receive robot animals immediately at commencement of the eight month trial. Receives: Device: Two Joy for All robots (one cat and one dog) |
| Delayed Intervention | Other | 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. Receives: Device: Two Joy for All robots (one cat and one dog) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at baseline, 4 months and 8 months
Secondary outcomes (6)
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: Measured at baseline, 4 months and 8 months
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: Measured at baseline, 4 months and 8 months
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: Measured at baseline, 4 months and 8 months
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.
Measured: 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
1:1 Care Applications
Will assess any changes in number of 1:1 care applications for each care home resident
Measured: 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
Review of diaries, staff interviews and staff summative review will allow qualitative assessment of impact that may have been missed on selected quantitative scales
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start1 Jan 2020
- Primary completion30 Oct 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Stepped-wedge, cluster randomised control trial
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Plymouth
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hannah Bradwell, University of Plymouth
- Investigators
- Hannah L Bradwell, MSc, Principal investigator, PhD Student, School of Nursing and Midwifery, University of Plymouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168463
- Sponsor's protocol ID
- 268571
- Status last verified
- Feb 2021
- First submitted
- 15 Nov 2019
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 11593958Strom 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.
PubMed 27965255Bradwell 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.
PubMed 35830959
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Use of Companion Robot Pets for Older Adults in Care Homes, an 8-month Stepped-wedge, Cluster Randomised Control Trial.
- ClinicalTrials.gov ID
- NCT04168463
- Acronym / sponsor ID
- 268571
- Conditions
- Aging, Dementia, Neuropsychiatric Symptoms, Wellbeing
- Keywords
- Dementia, Social robots, Companion robots, Robot pets, Wellbeing, Older adults, Long-term care, Residential care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University of PlymouthUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 19 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped-wedge, cluster randomised control trial
| Arm | Type | Receives |
|---|---|---|
| Immediate Intervention | Experimental | Device: Two Joy for All robots (one cat and one dog)This cluster of four homes will receive robot animals immediately at commencement of the eight month trial. |
| Delayed Intervention | Other | Device: Two Joy for All robots (one cat and one dog)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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Any resident at a collaborating care home or nursing home that has consent to participate.
Key exclusion criteria (1 listed)
- Any resident at a collaborating home without consent to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Two Joy for All robots (one cat and one dog)Also: Robot pets, Companion robotsIntervention will include the opportunity to interact with the Joy for All robot animals. | Device | Delayed Intervention, Immediate Intervention |
Primary outcome
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)
6 secondary outcomes
Challenging Behaviour Scale (Moniz-Cook et al., 2001)
Time frame: 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
Holden Communication Scale (Strøm et al., 2016)
Time frame: 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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Background: PubMed 11593958Moniz-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.
- Background: PubMed 27965255Strom 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.
- Derived from this study: PubMed 35830959Bradwell 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.
- Campaign to End Loneliness (n.d.)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hannah L Bradwell, MSc principal investigator
PhD Student, School of Nursing and Midwifery, University of Plymouth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Two Joy for All robots (one cat and one dog) in people with Aging and Dementia, run by University of Plymouth at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychiatric Inventory (Nursing Home Version) (Cummings, 1994) (time frame: Measured at baseline, 4 months and 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04168463, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021.