NCT04168463

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

February 23, 2021

Status Verified

February 1, 2021

Enrollment Period

10 months

First QC Date

November 15, 2019

Last Update Submit

February 20, 2021

Conditions

Keywords

DementiaSocial robotsCompanion robotsRobot petsWellbeingOlder adultsLong-term careResidential care

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Challenging Behaviour Scale (Moniz-Cook et al., 2001)

    Measured at baseline, 4 months and 8 months

  • Campaign to End Loneliness Measurement Tool (3-item) (Campaign to End Loneliness, n.d.)

    Measured at baseline, 4 months and 8 months

  • Holden Communication Scale (Strøm et al., 2016)

    Measured at baseline, 4 months and 8 months

  • Medication Use Review

    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 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 more secondary outcomes

Study Arms (2)

Immediate Intervention

EXPERIMENTAL

This cluster of four homes will receive robot animals immediately at commencement of the eight month trial.

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.

Device: Two Joy for All robots (one cat and one dog)

Interventions

Intervention will include the opportunity to interact with the Joy for All robot animals.

Also known as: Robot pets, Companion robots
Delayed InterventionImmediate Intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Plymouth

Plymouth, Devon, PL4 8AA, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 11593958BACKGROUND
  • 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.

    PMID: 27965255BACKGROUND
  • 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.

Related Links

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Hannah L Bradwell, MSc

    PhD Student, School of Nursing and Midwifery, University of Plymouth

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
N/A not possible
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Stepped-wedge, cluster randomised control trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 15, 2019

First Posted

November 19, 2019

Study Start

January 1, 2020

Primary Completion

October 30, 2020

Study Completion

January 1, 2021

Last Updated

February 23, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations