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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
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
Secondary ID [1] 298108 0
Nil Known
Universal Trial Number (UTN)
U1111-1232-4010
Trial acronym
Nil known
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Dementia 312639 0
Pain 312640 0
Behavioural problems 312641 0
Condition category
Condition code
Neurological 311136 311136 0 0
Dementias

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.

Intervention code [1] 314335 0
Not applicable
Comparator / control treatment
No control groups
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319969 0
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).
Timepoint [1] 319969 0
Pre-implementation of PainChek® at baseline (i.e. before App being implemented)
Secondary outcome [1] 370160 0
Nil
Timepoint [1] 370160 0
Nil

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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People with dementia and family carers exclusion criteria: Those not fluent in English or who have difficulty understanding English.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2019
Actual
Date of last participant enrolment
Anticipated
14/08/2019
Actual
Date of last data collection
Anticipated
31/08/2019
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 302639 0
University
Name [1] 302639 0
Curtin University
Country [1] 302639 0
Australia
Funding source category [2] 302642 0
Commercial sector/Industry
Name [2] 302642 0
PainChek Ltd (formerly known as EPAT Technologies)
Country [2] 302642 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] 302554 0
Commercial sector/Industry
Name [1] 302554 0
PainChek Ltd (formerly known as EPAT Technologies)
Address [1] 302554 0
Suite 401, 35 Lime St,
Sydney NSW 2000,
Country [1] 302554 0
Australia
Other collaborator category [1] 280658 0
Charities/Societies/Foundations
Name [1] 280658 0
Alzheimer’s WA
Address [1] 280658 0
55 Walters Drive
Osborne Park
WA 6017

PO Box 1509
Subiaco, WA 6904
Country [1] 280658 0
Australia
Other collaborator category [2] 280659 0
Charities/Societies/Foundations
Name [2] 280659 0
Dementia Support Australia (DSA)
Address [2] 280659 0
Suite 17A
151 Herdsman Parade
Wembley, WA 6014
Country [2] 280659 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303265 0
Human Research Ethics Committee (HREC), Curtin University
Ethics committee address [1] 303265 0
Ethics committee country [1] 303265 0
Australia
Date submitted for ethics approval [1] 303265 0
02/05/2019
Approval date [1] 303265 0
Ethics approval number [1] 303265 0

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

Contacts
Principal investigator
Name 93066 0
Prof Jeff Hughes
Address 93066 0
School of Pharmacy
Curtin University
GPO Box U1987
Perth Western Australia 6845
Country 93066 0
Australia
Phone 93066 0
+618 9266 7367
Fax 93066 0
+618 9266 2769
Email 93066 0
[email protected]
Contact person for public queries
Name 93067 0
Areej Hussein
Address 93067 0
School of Pharmacy
Curtin University
GPO Box U1987
Perth Western Australia 6845
Country 93067 0
Australia
Phone 93067 0
+61497853956
Fax 93067 0
Email 93067 0
[email protected]
Contact person for scientific queries
Name 93068 0
Areej Hussein
Address 93068 0
School of Pharmacy
Curtin University
GPO Box U1987
Perth Western Australia 6845
Country 93068 0
Australia
Phone 93068 0
+61497853956
Fax 93068 0
Email 93068 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
Confidentiality reasons


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.