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Trial registered on ANZCTR
Registration number
ACTRN12619000695101p
Ethics application status
Submitted, not yet approved
Date submitted
6/05/2019
Date registered
9/05/2019
Date last updated
9/05/2019
Date data sharing statement initially provided
9/05/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Investigating the views of stakeholders (family carers, people with dementia and healthcare professionals) about applying a new assessment technology to better detect and quantify pain in older people with dementia living in the community
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Scientific title
The implementation of ‘PainChek®’ in the community setting: Assessment of the barriers and enablers to the use of PainChek® and behavioural change mapping
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Secondary ID [1]
298108
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Nil Known
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Universal Trial Number (UTN)
U1111-1232-4010
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Trial acronym
Nil known
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Linked study record
Nil
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Health condition
Health condition(s) or problem(s) studied:
Dementia
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Pain
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Behavioural problems
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Condition category
Condition code
Neurological
311136
311136
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0
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Dementias
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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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.
This qualitative study focuses on investigating the views of stakeholders (family carers, people with dementia and healthcare professionals) regarding applying PainChek® to better detect and quantify pain in older people with dementia living in the community.
Three focus groups each consisting of 6-8 participants are proposed: a group of healthcare professionals from Dementia Support Australia (DSA), a group of family carers (i.e. person caring for a relative with dementia in their home) through DSA, and a group of patients with mild dementia (i.e. people with dementia but living independently or with support in their own home). The family carers and healthcare professionals will be recruited with the assistance of DSA. Whilst people living with dementia will be recruited with the assistance of Alzheimer’s WA. Focus groups will occur at baseline (i.e. before App being implemented). Focus groups will be conducted at a convenient time and in a comfortable place at the School of Pharmacy and Biomedical Sciences, Curtin University, and last approximately 50-90 minutes. All sessions will be run by an independent facilitator and audio recorded. The primary investigator will be present and take notes from the meeting.
The results of this study will be used to tailor strategies to facilitate family carers of people with dementia to use PainChek® to assess and monitor their loved one’s pain, and for people living with dementia who may wish to use the PainChek® a means to document their pain experience.
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Intervention code [1]
314335
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Not applicable
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Comparator / control treatment
No control groups
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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The views of stakeholders (family carers, people with dementia and healthcare professionals) about the challenges to using PainChek® by people caring for or living with dementia, and how might these challenges to overcome in the community. These challenges will be discussed through three focus group meetings using topic guide based on the COM-B model (Capability, Opportunity, Motivation - Behaviour) within the Behaviour Change Wheel (BCW).
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Assessment method [1]
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Timepoint [1]
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Pre-implementation of PainChek® at baseline (i.e. before App being implemented)
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Secondary outcome [1]
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Nil
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Assessment method [1]
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Timepoint [1]
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Nil
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Eligibility
Key inclusion criteria
Three focus groups each consisting of 6-8 participants are proposed: a group of healthcare professionals (from Dementia Support Australia consultants), a group of family carers (i.e. person caring for a relative with dementia in their home), and a group of patients with mild dementia (i.e. people with dementia but living independently or with support in their own home).
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
People with dementia and family carers exclusion criteria: Those not fluent in English or who have difficulty understanding English.
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Convenience sample
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Timing
Prospective
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Statistical methods / analysis
This study is being undertaken to identify the potential obstacles to the PainChek® app’s use by consumers and how these obstacles might be overcome. The number and size of the focus groups was chosen based on the recommendations of Leung F, Savithiri R. (Spotlight on focus groups) and Slaughter et. al. (Focus Groups in Health Services Research at the Institute for Clinical Evaluative Sciences).
Data analysis: An interview guide based on the Theoretical Domain Framework (TDF) will be designed to prompt focus group discussions. Audio-recorded data from the focus group meetings will be transcribed verbatim. Specifically, audio-recorded data will be re-listened to and compared with the notes taken. Transcribed data will be imported and thematically coded into the NVivo® V12 program and organized according to topics independently by two researchers. The TDF, COM-B model of the BCW and BCTs will be used as deductive frameworks for the analysis. At the final stage of the data analysis, the yielded themes will be compared, to identify and resolve any discrepancies. The results of this study will be used to tailor strategies to facilitate family carers of people with dementia to use PainChek® to assess and monitor their loved one’s pain, and for people living with dementia who may wish to use the App as a means to document their pain experience
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/08/2019
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Actual
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Date of last participant enrolment
Anticipated
14/08/2019
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Actual
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Date of last data collection
Anticipated
31/08/2019
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Actual
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Sample size
Target
24
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Curtin University
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Address [1]
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Kent Street, Bentley, Perth, Western Australia 6102
Postal address: GPO Box U1987, Perth WA 6845
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Country [1]
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Australia
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Funding source category [2]
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Commercial sector/Industry
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Name [2]
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PainChek Ltd (formerly known as EPAT Technologies)
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Address [2]
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Suite 401, 35 Lime St,
Sydney NSW 2000,
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Country [2]
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Australia
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Primary sponsor type
University
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Name
Curtin University
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Address
Kent Street, Bentley, Perth, Western Australia 6102
Postal address: GPO Box U1987, Perth WA 6845
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Country
Australia
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Secondary sponsor category [1]
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Commercial sector/Industry
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Name [1]
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PainChek Ltd (formerly known as EPAT Technologies)
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Address [1]
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Suite 401, 35 Lime St,
Sydney NSW 2000,
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Country [1]
302554
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Australia
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Other collaborator category [1]
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Charities/Societies/Foundations
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Name [1]
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Alzheimer’s WA
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Address [1]
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55 Walters Drive
Osborne Park
WA 6017
PO Box 1509
Subiaco, WA 6904
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Country [1]
280658
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Australia
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Other collaborator category [2]
280659
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Charities/Societies/Foundations
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Name [2]
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Dementia Support Australia (DSA)
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Address [2]
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Suite 17A
151 Herdsman Parade
Wembley, WA 6014
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Country [2]
280659
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Australia
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
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Human Research Ethics Committee (HREC), Curtin University
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Ethics committee address [1]
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Kent Street, Bentley, Perth, Western Australia 6102
Postal address: GPO Box U1987, Perth WA 6845
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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02/05/2019
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Approval date [1]
303265
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Ethics approval number [1]
303265
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Summary
Brief summary
Pain often goes unrecognised and under-treated in people with communication difficulties such as those with dementia. Although, tools exit to assess pain in people with dementia, they are often subjective, manually based and subsequently underutilised. 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.
A number of studies have reported that PainChek® (formerly known as ePAT) is valid, reliable and accurate in identifying pain in people with moderate to severe dementia living in aged care facilities. It has also been used to assess pain in community-dwelling people with dementia referred to Dementia Support Australia. However, to date its use by family carers of people with dementia, and by people with mild dementia as an aide- memoire have not been studied. The study will therefore focus on investigating the views of stakeholders (family caregivers, people suffering from dementia and healthcare professionals) about applying PainChek® to better detect and measure pain in older people with dementia and those living in the community. The results of this study will be used to adapt strategies to facilitate family carers of people with dementia to use PainChek® to assess and monitor the pain of their loved ones, and for people with dementia who may wish to use the application as a way to document their pain experience.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Jeff Hughes
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Address
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School of Pharmacy
Curtin University
GPO Box U1987
Perth Western Australia 6845
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Country
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Australia
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Phone
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+618 9266 7367
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Fax
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+618 9266 2769
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Email
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[email protected]
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Contact person for public queries
Name
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Mrs Areej Hussein
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Address
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School of Pharmacy
Curtin University
GPO Box U1987
Perth Western Australia 6845
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Country
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Australia
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Phone
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+61497853956
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Mrs Areej Hussein
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Address
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School of Pharmacy
Curtin University
GPO Box U1987
Perth Western Australia 6845
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Country
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Australia
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Phone
93068
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+61497853956
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Fax
93068
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Email
93068
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Confidentiality reasons
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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.
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