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Trial registered on ANZCTR


Registration number
ACTRN12621000837820
Ethics application status
Approved
Date submitted
14/05/2021
Date registered
30/06/2021
Date last updated
31/01/2022
Date data sharing statement initially provided
30/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A feasibility RCT to assess the usability of the PainChek app to assess pain and scoping of cost implications
Scientific title
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
Secondary ID [1] 304214 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dementia 321909 0
Pain 321910 0
Condition category
Condition code
Neurological 319638 319638 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The PersonAl RObot (PARO) is a therapeutic robot and a non-pharmacological intervention that has no significant negative side effects. 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. Taking care of PARO can make people feel happy and they may enjoy having PARO as a companion, which reflects the therapeutic effects of PARO on users.

In this study, participants randomised to Intervention Group 1 will receive a 15-minute non-facilitated individual (one-on-one) PARO intervention for 2 sessions per day from Monday to Friday. Participants assigned to Intervention Group 2 will receive a 15-minute non-facilitated individual (one-on-one) PARO intervention for 1 session per day from Monday to Friday. The intervention will be three 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 three-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] 320552 0
Treatment: Devices
Comparator / control treatment
Participants in the Control Group will receive a 15-minute non-facilitated individual (one-on-one) Plush Toy intervention for 1 session per day from Monday to Friday for three 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 three-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] 327528 0
Feasibility of using the PainChek app regarding the clinical applicability of the tool, including training, completion rates, costs and benefits assessed by an audit of the study database. The cost of this study (e.g., labour, equipment, travel, recruitment, training, intervention delivery, etc) will be recorded. A resource checklist and data collection matrix will be designed to calculate the potential cost offsets and appropriate data collection methods for a future cost-effectiveness analysis.
Timepoint [1] 327528 0
Week 4 after commencement of the intervention
Primary outcome [2] 327835 0
Participants' perceptions and acceptability of using PainChek will be assessed by semi-structured interviews,
Timepoint [2] 327835 0
Week 4 after commencement of the intervention
Primary outcome [3] 327836 0
Family carers' perceptions and acceptability of using PainChek assessed by semi-structured one-on-one interviews,
Timepoint [3] 327836 0
Week 4 after commencement of the intervention
Secondary outcome [1] 395523 0
Pain levels measured by PainChek
Timepoint [1] 395523 0
Before and after each PARO or Plush-toy session
Secondary outcome [2] 395524 0
Pain levels measured by the Abbey Pain Scale
Timepoint [2] 395524 0
Week 4 and week 8 after commencement of the intervention
Secondary outcome [3] 395525 0
Neuropsychiatric symptoms using the Neuropsychiatric Inventory-nursing home version
Timepoint [3] 395525 0
Week 4 and week 8 after commencement of the intervention
Secondary outcome [4] 395526 0
Quality of life measured by a generic instrument EuroQoL 5-Dimensions (EQ-5D)
Timepoint [4] 395526 0
Week 4 and week 8 after commencement of the intervention
Secondary outcome [5] 396723 0
Quality of life measured by a dementia-specific instrument Quality of Life in Alzheimer’s disease (QoL-AD)
Timepoint [5] 396723 0
Week 4 and week 8 after commencement of the intervention
Secondary outcome [6] 396724 0
Regularly scheduled medication consumption determined by review of medical records being assessed by the Modification Quantification Scale Version III (MQS III )
Timepoint [6] 396724 0
Week 4 and week 8 after commencement of the intervention
Secondary outcome [7] 396726 0
As needed PRN medication consumption determined by review of medical records being assessed by the Modification Quantification Scale Version III (MQS III )
Timepoint [7] 396726 0
Week 4 and week 8 after commencement of the intervention
Secondary outcome [8] 396727 0
Care staff's perceptions and acceptability of using PainChek will be assessed by a semi-structured one-on-one interview
Timepoint [8] 396727 0
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; and
(4) 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)
The random order for the allocation of subjects into different groups will be undertaken via Griffith University secure web-based system.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Demographics and feasibility data will be analysed using descriptive statistics. Multiple imputation will be used to manage missing data and an intention-to-treat approach will be applied for data analysis. A General Linear Model (GLM) with repeated measures will be used to determine differences between groups (with 3 levels: double dose intervention, single-dose intervention, control) and within groups over time (with 3 levels: baseline, end of treatment at week 4, follow-up at week 8). Cohen’s d effect size will be calculated for the sample size estimation for a larger trial. Statistical significance will be set at the alpha level of 0.05. Analyses will be performed using IBM SPSS Statistics (version 26.0). Interview data will be transcribed and analysed with the help of NVivo using thematic analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2021
Actual
19/07/2021
Date of last participant enrolment
Anticipated
30/10/2021
Actual
3/09/2021
Date of last data collection
Anticipated
31/03/2022
Actual
5/11/2021
Sample size
Target
45
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 34045 0
4205 - Bethania

Funding & Sponsors
Funding source category [1] 308589 0
University
Name [1] 308589 0
Griffith Univiersity
Country [1] 308589 0
Australia
Primary sponsor type
University
Name
Menzies Health Institute Queensland, Griffith University
Address
170 Kessels Road Nathan Campus, Griffith University, Brisbane, Queensland 4111, Australia
Country
Australia
Secondary sponsor category [1] 309448 0
None
Name [1] 309448 0
Address [1] 309448 0
Country [1] 309448 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308525 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 308525 0
Human Research Ethics Office for Research
170 Kessels Road Nathan Campus, Griffith University, Brisbane, Queensland 4111, Australia
Ethics committee country [1] 308525 0
Australia
Date submitted for ethics approval [1] 308525 0
23/03/2021
Approval date [1] 308525 0
19/04/2021
Ethics approval number [1] 308525 0
reference number: 2021/221

Summary
Brief summary
Chronic pain is a common problem but often undiagnosed and untreated in people with dementia due to their cognitive impairment and limited communication ability, leading to reduced quality of life and increased healthcare costs. The efficacy and economic value of interventions to reduce pain in people with dementia remains unclear due to a lack of clinically useful pain assessment tools for this group. This study will (1) determine the feasibility of an artificial intelligence-based application (PainChek) to measure pain in people with dementia; (2) identify the optimal dosage and efficacy of a social robot (PARO) intervention; and (3) develop a checklist of cost-effectiveness measures. A sample of 45 residents with dementia will be randomly allocated to Intervention Group 1 (15-minute PARO intervention, 2×/day) or Intervention Group 2 (15-minute PARO intervention, 1×/day), or the Control Group (15-minute Plush Toy, 1×/day), for 4 weeks and follow-up at week 8. Primary outcomes include the feasibility of using the PainChek to evaluate the intervention efficacy and cost-effectiveness needs within a larger trial. Secondary outcomes are neuropsychiatric symptoms, medication use and participants’ quality of life. This novel project will improve pain management in people with dementia, and potentially reduce treatment costs.
Trial website
Trial related presentations / publications
Public notes
This is Phase I Feasibility study of a large cluster-randomised controlled study entitled "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" (GU Ref No: 2021/221). Participants, family and outcome assessors will be blinded to the group allocation.

Contacts
Principal investigator
Name 111010 0
Prof Wendy Moyle
Address 111010 0
School of Nursing and Midwifery & Menzies Health Institute
170 Kessels Rd, Nathan Campus, Griffith University, Brisbane. QLD,4111, Australia
Country 111010 0
Australia
Phone 111010 0
+610737355526
Fax 111010 0
Email 111010 0
[email protected]
Contact person for public queries
Name 111011 0
Lihui Pu
Address 111011 0
School of Nursing and Midwifery & Menzies Health Institute
170 Kessels Rd, Nathan Campus, Griffith University, Brisbane. QLD,4111, Australia
Country 111011 0
Australia
Phone 111011 0
+610737357212
Fax 111011 0
Email 111011 0
[email protected]
Contact person for scientific queries
Name 111012 0
Lihui Pu
Address 111012 0
School of Nursing and Midwifery & Menzies Health Institute
170 Kessels Rd, Nathan Campus, Griffith University, Brisbane. QLD,4111, Australia
Country 111012 0
Australia
Phone 111012 0
+610737357212
Fax 111012 0
Email 111012 0
[email protected]

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.