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NCT Number: NCT04168463

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

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.

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Key information

Conditions

Aging Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neuropsychiatric Symptoms Wellbeing

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Plymouth

Plymouth, Devon, PL4 8AA, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Device

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

Other names: Robot pets, Companion robots

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

    Will assess any changes in number of 1:1 care applications for each care home resident

  6. 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

Sponsors and collaborators

Lead sponsor

University of Plymouth

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Nov 19, 2019
Registry last updated
Feb 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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