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Trial registered on ANZCTR


Registration number
ACTRN12619000706178p
Ethics application status
Submitted, not yet approved
Date submitted
6/05/2019
Date registered
10/05/2019
Date last updated
10/05/2019
Date data sharing statement initially provided
10/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The feasibility and usability of “Pain Check®" as a tool to assist persons with dementia in documenting and sharing their pain experience with healthcare professionals
Scientific title
The implementation of ‘PainChek®’ in the community setting: As an aide-memoir for people with mild dementia
Secondary ID [1] 298165 0
Nil Known
Universal Trial Number (UTN)
U1111-1232-4010
Trial acronym
Nil known
Linked study record
Nil known

Health condition
Health condition(s) or problem(s) studied:
Dementia 312720 0
Pain 312721 0
Behavioural problems 312722 0
Condition category
Condition code
Neurological 311221 311221 0 0
Dementias
Neurological 311272 311272 0 0
Alzheimer's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
PainChek® is an approved medical device in the form of a smart device app, which combines artificial intelligence and smart automation to identify and quantify pain in real time. The app has been validated and used for assessing pain in people with moderate to severe dementia. PainChek® works by using facial recognition technology and analysis to detect pain through facial muscle movements which indicate the presence of pain. The user then enters other observed pain cues (e.g. vocalisation, movements and behaviours) exhibited by the patient via a series of checklists, and the app automatically calculates a pain score and assigns a pain intensity. The app does not store any images of the patient and adheres to strict medical privacy and confidentiality legislation. Over time the app provides the user with a record of the patient’s pain experience including the intensity of their pain and how the pain impacted on how they feel and behaved.
In the context of this study, a person living with dementia would use PainChek® to document their pain experience, effectively using the app as an electronic pain diary. He or she could then share this information with the clinician looking after their pain.
This study will be conducted in community-dwelling people with mild dementia to allow them to document their own pain for 6 months. The primary researcher will be in contact with the people with mild dementia either by face to face or via teleconference.They will be provided with in-app and online training (accessible from the app), be supported by the primary researcher and the PainChek Ltd (www.painchek.com). They will be instructed regularly document their pain, both weekly and on an as required basis. They will also be contacted weekly by the primary researcher to ascertain if they are comfortable using the app and to address any questions or concerns about its use. .
The outcome of these studies includes the Health-ITUES scores (usability feedback). The Health-ITUES consists of 20 items, with the higher scores correlating to higher technology usability. The 20-item scale consists of four subscales: (1) quality of work life, (2) perceived usefulness, (3) perceived ease of use, and (4) user control. The clinical impact of using PainChek® will be examined by evaluating pain severity scores that will already be collected from PainChek®.
Intervention code [1] 314390 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319979 0
Perceived usability of PainChek® over time is assessed by people with mild dementia using Health-ITUES questionnaire.
Timepoint [1] 319979 0
This survey will be conducted twice:
1)Pre-implementation (before using PainChek®)
2) Post-implementation of PainChek® after 6 months
Primary outcome [2] 320016 0
Pain Severity scores: Pain intensity is assessed using PainChek®. PainChek® scale will be used as an aide- memoire for people with mild dementia.
Timepoint [2] 320016 0
During the implementation of PainChek®(at least once weekly for 6 months)
Secondary outcome [1] 370253 0
Nil
Timepoint [1] 370253 0
Nil

Eligibility
Key inclusion criteria
Inclusion criteria of the participants includes: diagnosed or classified with mild dementia by their general practitioner or specialist, living independently at home, i.e. are able to complete activities of daily living, have a past medical history of pain, are current smart device user and are willing to participate.

Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People with dementia exclusion criteria:
1) If the people with dementia is clinically unwell, deemed ineligible or if it is inappropriate to include.
2)Those not fluent in English or who have difficulty understanding English

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
The study will be conducted in 30 community-dwelling people with mild dementia to allow them to assess their own pain using PainChek® for 6 months.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A smaller sample proposed (n=30) will be sufficient to detect a moderate to large effect size of 0.52, with 80% power.
Data analysis: Quantitative data will be analysed using SPSS® V23 for Windows. Mean changes in the Health-ITUES scores (and other variables measured on a continuous scale) from pre to post implementation will be assessed for statistical significance using paired t-tests. A General Linear Model (GLM) will be used to identify if changes in the Health-ITUES scores may be associated with any other baseline or demographic variables (for example, changes in scores may be dependent on some baseline characteristics like pain score and may also differ according to age-group or gender). The Chi-square test will be used to identify significance of changes for dichotomous and categorical variables. Following convention, a p-value<0.05 will be taken to indicate a statistically significant association in all tests. Further, descriptive statistics (eg, mean, median) will be used to summarise the study participants and number of assessments conducted over time (pain scores), while inferential statistics (eg, CI) will be used to determine the level of significance.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2020
Actual
Date of last participant enrolment
Anticipated
31/03/2020
Actual
Date of last data collection
Anticipated
1/09/2020
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 302696 0
University
Name [1] 302696 0
Curtin University
Country [1] 302696 0
Australia
Funding source category [2] 302697 0
Commercial sector/Industry
Name [2] 302697 0
PainChek Ltd (formerly known as EPAT Technologies)
Country [2] 302697 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent Street, Bentley, Perth, Western Australia 6102
Postal address: GPO Box U1987, Perth WA 6845
Country
Australia
Secondary sponsor category [1] 302625 0
Commercial sector/Industry
Name [1] 302625 0
PainChek Ltd (formerly known as EPAT Technologies)
Address [1] 302625 0
Suite 401, 35 Lime St,
Sydney NSW 2000,
Country [1] 302625 0
Australia
Other collaborator category [1] 280682 0
Charities/Societies/Foundations
Name [1] 280682 0
Alzheimer’s WA
Address [1] 280682 0
55 Walters Drive
Osborne Park
WA 6017
PO Box 1509
Subiaco, WA 6904
Country [1] 280682 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303310 0
Human Research Ethics Committee (HREC), Curtin University
Ethics committee address [1] 303310 0
Ethics committee country [1] 303310 0
Australia
Date submitted for ethics approval [1] 303310 0
02/05/2019
Approval date [1] 303310 0
Ethics approval number [1] 303310 0

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

Contacts
Principal investigator
Name 93222 0
Prof Jeff Hughes
Address 93222 0
School of Pharmacy
Curtin University
GPO Box U1987
Perth Western Australia 6845
Country 93222 0
Australia
Phone 93222 0
+61 8 9266 7367
Fax 93222 0
+618 9266 2769
Email 93222 0
J.D.Hughes@curtin.edu.au
Contact person for public queries
Name 93223 0
Areej Hussein
Address 93223 0
School of Pharmacy
Curtin University
GPO Box U1987
Perth Western Australia 6845
Country 93223 0
Australia
Phone 93223 0
+61497853956
Fax 93223 0
Email 93223 0
a.hussein1@postgrad.curtin.edu.au
Contact person for scientific queries
Name 93224 0
Areej Hussein
Address 93224 0
School of Pharmacy
Curtin University
GPO Box U1987
Perth Western Australia 6845
Country 93224 0
Australia
Phone 93224 0
+61497853956
Fax 93224 0
Email 93224 0
a.hussein1@postgrad.curtin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
It is anticipated that the results of this research project will be published and/or presented in a variety of forums. For the purpose of presentation and/or publication all data will be group to ensure no individual can be identified.
When will data be available (start and end dates)?
Beginning 3 months and ending 7 years following main results publication
Available to whom?
During the study, data will be stored on a password protected computer at Curtin University that only the research team (Primary Researcher, Supervisor, Co-supervisors) can access
Available for what types of analyses?
Only to achieve the aims in the approved proposal,
How or where can data be obtained?
access subject to approvals by Principal Investigator,


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.