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Trial registered on ANZCTR


Registration number
ACTRN12621001010886
Ethics application status
Approved
Date submitted
9/07/2021
Date registered
2/08/2021
Date last updated
4/07/2022
Date data sharing statement initially provided
2/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the effectiveness of a social robot intervention on pain management in people with dementia living in residential aged care facilities: A cluster randomised controlled trial
Scientific title
Evaluating the effectiveness of a social robot intervention on pain management in people older than 65 and older who have dementia living in residential aged care facilities: A cluster randomised controlled trial
Secondary ID [1] 304467 0
None.
Universal Trial Number (UTN)
Trial acronym
Linked study record
This is a follow-up study of a previously registered trial (ACTRN12621000837820) entitled "A feasibility RCT to assess the usability of the PainChek app to assess pain in adults aged 65 and older who have dementia, and scoping of cost implications".

Health condition
Health condition(s) or problem(s) studied:
Dementia 322295 0
Chronic pain 322296 0
Condition category
Condition code
Neurological 319971 319971 0 0
Dementias
Anaesthesiology 320469 320469 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The PersonAl RObot (PARO) is a therapeutic robot and a non-pharmacological intervention for people with dementia. PARO has the appearance of a baby harp seal and is covered with artificial fur, which is soft and warm to touch. It has the following four senses: sight, hearing, balance and tactile senses. PARO has two optical nose sensors to recognise the source of light and has a diurnal rhythm of sleep or movement according to the light sources and stimulation of the sensors. PARO also has three microphones in its ears to detect sound source direction and speech recognition, such as its name or greetings, as well as some simple words. It contains a posture sensor to maintain balance and recognises its posture when it is held by a user. For motion, it has seven silent intelligent actuators to open and close its eyes and move its neck and its front and rear flippers. Thus PARO combines these four senses to respond and communicate with users by moving or making a sound. The voice of PARO was recorded from a real baby harp seal. PARO can also learn users’ preference for its behaviour and has emotions such as happiness or anger.

In this study, participants living in residential aged care facilities randomised to Intervention Group will receive a 15-minute non-facilitated individual (one-on-one) PARO intervention per day from Monday to Friday for four weeks and we will follow up at week 8.

In each session, trained research assistants (RAs) will introduce PARO to a participant and leave the robot to the participant for 15 minutes. RAs will record the time, duration and interactions of participants with PARO for each session using an observation diary.

Before and after each session, trained research assistants (RAs) will assess the pain levels of participants using the PainChek app during the four-week intervention. The RA will use a Tablet camera to capture a three-second video of the facial expressions of participants. The facial indicators of pain will be detected automatically and the RA will record other pain-related behaviours such as voice, movement, behaviour, activity and body language via the PainChek app. It takes around two minutes to complete the assessment.
Intervention code [1] 320817 0
Treatment: Devices
Comparator / control treatment
Participants living in the residential aged care facilities in the Control Group will receive a 15-minute non-facilitated individual (one-on-one) Plush Toy intervention per day from Monday to Friday for four weeks and we will follow up at week 8. The plush toy will be a PARO with all robotic and artificial intelligence capabilities disabled.

In each session, trained research assistants (RAs) will introduce the plush toy to a participant and leave the toy to the participant for 15 minutes.

RAs will record the time, duration and interactions of participants with the plush toy for each session using an observation diary.

Before and after each session, trained research assistants (RAs) will assess the pain levels of participants using the PainChek app during the four-week intervention. The RA will use a Tablet camera to capture a three-second video of the facial expressions of participants. The facial indicators of pain will be detected automatically and the RA will record other pain-related behaviours such as voice, movement, behaviour, activity and body language via the PainChek app. It takes around two minutes to complete the assessment.
Control group
Active

Outcomes
Primary outcome [1] 327915 0
Pain levels measured by PainChek app
Timepoint [1] 327915 0
Assessed before and after each PARO or Plush-toy session (primary endpoint) for 4 weeks
Primary outcome [2] 327916 0
Pain levels measured by the Abbey Pain Scale
Timepoint [2] 327916 0
Assessed at baseline, weeks 4 (primary endpoint) and week 8 after commencement of the intervention.
Primary outcome [3] 327917 0
Neuropsychiatric symptoms using the Neuropsychiatric Inventory-nursing home version
Timepoint [3] 327917 0
Assessed at baseline, weeks 4 (primary endpoint) and week 8 after commencement of the intervention.
Secondary outcome [1] 396997 0
Quality of life measured by a generic instrument EuroQoL 5-Dimensions (EQ-5D)
Timepoint [1] 396997 0
Assessed at baseline, weeks 4 (primary endpoint) and week 8 after commencement of the intervention.
Secondary outcome [2] 396998 0
Quality of life measured by a dementia-specific instrument Quality of Life in Alzheimer’s disease (QoL-AD)
Timepoint [2] 396998 0
Assessed at baseline, weeks 4 (primary endpoint) and week 8 after commencement of the intervention.
Secondary outcome [3] 396999 0
Regularly scheduled medication consumption determined by review of medical records being assessed by the Modification Quantification Scale Version III (MQS III)
Timepoint [3] 396999 0
Assessed at baseline, weeks 4 (primary endpoint) and week 8 after commencement of the intervention.
Secondary outcome [4] 397000 0
As needed PRN medication consumption determined by review of medical records being assessed by the Modification Quantification Scale Version III (MQS III)
Timepoint [4] 397000 0
Assessed at baseline, weeks 4 (primary endpoint) and week 8 after commencement of the intervention.
Secondary outcome [5] 397001 0
The cost-effectiveness analysis will calculate the cost of the PARO intervention for the incremental cost per unit improvement in pain levels measured by using the PainChek app between the PARO and Plush Toy group. The cost-utility analysis will calculate the incremental cost per quality-adjusted life-years (QALYs) using Quality of Life in Alzheimer’s disease (QoL-AD),
Timepoint [5] 397001 0
Assessed at weeks 4 after commencement of the intervention.
Secondary outcome [6] 397002 0
Process evaluation (1) implementation (process evaluations of intervention fidelity) using audit of observation records.
Timepoint [6] 397002 0
Assessed daily during the 4-week intervention
Secondary outcome [7] 398502 0
Process evaluation (2) mechanisms of impact (participants experience and interactions) through semi-structured interviews with participants.
Timepoint [7] 398502 0
Assessed at week 4 after commencement of the intervention
Secondary outcome [8] 398503 0
Process evaluation (3) contextual factors (barriers and facilitators of using PainChek app and the social robot PARO) via semi-structured interviews and focus groups with key stakeholders (i.e., people with dementia, family and care staff)
Timepoint [8] 398503 0
Assessed at week 4 after commencement of the intervention

Eligibility
Key inclusion criteria
(1) Age 65 years and older and can speak and understand English.
(2) Participants must have been diagnosed with some form of dementia.
(3) Participants are assumed to experience chronic pain if they report and have regular pain medication.
(4) Demonstration of sensation and perception to allow interaction with PARO.
(5) Living in the care facility for more than 3 months.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Diseases such as acute exacerbation of chronic obstructive pulmonary disease that requires residents to be admitted to hospital frequently;
(2) Terminal illnesses where the resident is in the final palliative stage;
(3) A diagnosis of a major mental illness, such as schizophrenia;
(4) A diagnosis of Parkinson’s Disease as their facial features could have been compromised due to the nature and progress of the condition; and
(5) Infectious diseases, such as acquired immune deficiency syndrome, COVID-19, or tuberculosis, or an open wound that is unable to be covered.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be undertaken via Griffith University secure web-based system.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
To prevent treatment contamination within the same study site, a cluster-randomised controlled trial (C-RCT) will be conducted. Six Australian Government approved and accredited facilities will be randomly assigned to either the intervention group or the control group. Randomisation of clusters will be undertaken via the Griffith University secure web-based system. Participants, family and outcome assessors will be blinded to the group allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Frequency and percentages will be used for ordinal or categorical variables while mean and standard deviation will be used to describe continuous variables with normal distribution and the median for data with skewed distribution. An intention-to-treat approach will be applied for data analysis. Multilevel mixed-effects linear regression models will be undertaken for primary and secondary outcomes. Statistical significance will be set at the alpha level of 0.05. Health economic evaluations will use STATA/SE (version 16.0) (StataCorp, College Station, TX). Non-parametric bootstrapping will provide 95% credible intervals to economic outcomes. Qualitative data will be transcribed into NVivo 11.0 and analysed using thematic analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2021
Actual
2/05/2022
Date of last participant enrolment
Anticipated
31/07/2022
Actual
Date of last data collection
Anticipated
31/01/2023
Actual
Sample size
Target
92
Accrual to date
40
Final

Funding & Sponsors
Funding source category [1] 308882 0
University
Name [1] 308882 0
Griffith University
Country [1] 308882 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
170 Kessels Road Nathan Campus, Griffith University, Brisbane, Queensland 4111, Australia
Country
Australia
Secondary sponsor category [1] 309805 0
None
Name [1] 309805 0
Address [1] 309805 0
Country [1] 309805 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308738 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 308738 0
Ethics committee country [1] 308738 0
Australia
Date submitted for ethics approval [1] 308738 0
23/03/2021
Approval date [1] 308738 0
19/04/2021
Ethics approval number [1] 308738 0
2021/221
Ethics committee name [2] 308787 0
UnitingCare Queensland Human Research Ethics Committee
Ethics committee address [2] 308787 0
Ethics committee country [2] 308787 0
Australia
Date submitted for ethics approval [2] 308787 0
15/03/2021
Approval date [2] 308787 0
19/04/2021
Ethics approval number [2] 308787 0
PU 20210315

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111718 0
Dr Lihui Pu
Address 111718 0
School of Nursing and Midwifery & Menzies Health Institute
170 Kessels Rd, Nathan Campus, Griffith University, Brisbane. QLD,4111, Australia
Country 111718 0
Australia
Phone 111718 0
+610737357212
Fax 111718 0
Email 111718 0
l.pu@griffith.edu.au
Contact person for public queries
Name 111719 0
Lihui Pu
Address 111719 0
School of Nursing and Midwifery & Menzies Health Institute
170 Kessels Rd, Nathan Campus, Griffith University, Brisbane. QLD,4111, Australia
Country 111719 0
Australia
Phone 111719 0
+610737357212
Fax 111719 0
Email 111719 0
l.pu@griffith.edu.au
Contact person for scientific queries
Name 111720 0
Lihui Pu
Address 111720 0
School of Nursing and Midwifery & Menzies Health Institute
170 Kessels Rd, Nathan Campus, Griffith University, Brisbane. QLD,4111, Australia
Country 111720 0
Australia
Phone 111720 0
+610737357212
Fax 111720 0
Email 111720 0
l.pu@griffith.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No participant permission to share data beyond this study.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.