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Trial registered on ANZCTR


Registration number
ACTRN12619000696190p
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
The Efficacy, feasibility and usability of using "Pain Check®" as a tool to assist family caregivers in assessing and monitoring the pain of their loved one's with severe dementia
Scientific title
The implementation and clinical impact of PainChek® in the community setting: As an assistant tool for family carers to assess and monitor pain in their relatives with severe dementia
Secondary ID [1] 298163 0
Nil Known
Universal Trial Number (UTN)
U1111-1232-4010
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 312716 0
Dementia 312717 0
Behavioural problems 312718 0
Condition category
Condition code
Neurological 311218 311218 0 0
Dementias
Neurological 311260 311260 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.

Design and setting: This study will be conducted with family carers using PainChek® to assist pain assessment and monitoring of their relatives. The implementation study will be undertaken with assistance of Dementia Support Australia (DSA) consultants. DSA consultants have been using PainChek® since September 2017.
Method: DSA consultants will first assess the client for pain using PainChek®. If pain is identified as a potential contributing factor to the client’s behavioural change issues, the DSA consultants will check the eligibility of the family carers and offer them the use of PainChek® via a shared care model as part of the study. If they are interested, DSA consultants will explain the study to them and provide them with a copy of the Participant Information Statements and Information Brochure. Having answered any questions, the interested family carers will then be asked to sign the consent form. Once the consent form is signed, DSA consultants need to photograph it and send a copy to the primary researcher via a prepaid self-addressed envelope. The DSA consultants will then assist the family carers in downloading the App and demonstrate how to use it. The family carers will also be provided with access to online training and support via PainChek Ltd (www.painchek.com) and the primary researcher.The duration of face to face training workshop provided to the family carers is 2.5 hour. At the end of the training duration the DSA consultants will provide the family carers with a survey to complete. Participants will be asked to complete and return the survey in the prepaid self-addressed envelope within 7 days.This survey is divided into three sections and it will not take more than 10-15 minutes. Section A includes 20 statements about users’ (Family carers) perceptions of the potential usefulness of PainChek® as a means of assessing their loved one’s pain. These statements called ‘Health-ITUES’ are rated using a 5-point Likert scale (1= Strongly disagree and 5 = Strongly agree). 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. Section B includes questions around the use of mobile technologies, and in Section C, there will be a number of questions about the participants’ age, gender, marital status, living arrangements, educational attainment, and in the case of those people with dementia the type of dementia (vascular, Alzheimer’s, frontotemporal, Lewy’s bodies, or mixed or unknown), degree of cognitive impairment, past medical history and medication history.
DSA consultants should recommend the family carers routinely assess (at least once a week) their loved one’s pain for 2 months whilst they are under the care of DSA. When the period of study is finished, family carers will again be asked to complete a short survey about their experience using the app.

Intervention code [1] 314387 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319971 0
Pain Severity scores: Pain intensity is assessed using PainChek®. PainChek® scale will be used to assist family carers in assessing and monitoring pain of their relatives with moderate-severe dementia.
Timepoint [1] 319971 0
During the implementation of PainChek® From week 1-8 (at least once per week)
Primary outcome [2] 319974 0
Behavioural change problems (rated by neuropsychiatric inventory-nursing home version (NPI-NH))
Timepoint [2] 319974 0
NPI-NH will be conducted twice:
1)Before implementation/introduction of the PainChek® (Day 1, Week 0)
2) At the end of Week 8: Post-implementation to compare with previous time point of data collection
Overall, these data are collected to review changes that occurred in participants’ outcomes over time as a result of using PainChek® by family carers
Primary outcome [3] 319975 0
Perceived usability of PainChek® over time is assessed by family carers using Health-ITUES questionnaire. (Survey)
Timepoint [3] 319975 0

1)Pre-implementation (before using PainChek®)
2) Post-implementation of PainChek® after 8 weeks.
Secondary outcome [1] 370161 0
Nil
Timepoint [1] 370161 0
Nil

Eligibility
Key inclusion criteria
Inclusion criteria for family carers: holding power of attorney; providing care for 3 months in community setting, involved in the ongoing care of a person with moderate to severe dementia (MMSE less than or equal to 18 or Psychogeriatric Assessment Scales – cognitive scores greater than or equal to 10), be a spouse/partner or child/grandchild or aunt/uncle or niece/nephew or sibling of the PwD, and current user of a smart device
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People with dementia exclusion criteria: If the people with dementia is clinically unwell, deemed ineligible or if it is inappropriate to include.
Family carers exclusion criteria: 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 with 100 family carers using PainChek® to assist pain assessment and monitoring of their loved ones with moderate-severe dementia for 8 weeks.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 100 family carers of a relative with advanced dementia living at home is planned, which will allow detection of a small effect size of 0.30, 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.

The clinical outcomes of using PainChek® include pain intensity which is assessed using PainChek® and behavioural symptoms severity that will be measured over time using Neuropsychiatric Inventory (NPI). Dementia Support Australia staff will measure the NPI for their clients at enrolment and discharge from the service.
Data analysis Since there will be only pairs of measurements for each participant (pre- and post- implementation), paired t-tests or Chi-square tests will be used to analyse changes in NPI, as appropriate. If the change in NPI score is found to be skewed, it will be subjected to a Box-Cox transformation prior to further analysis. This transformation acts to reduce skewness and bring the distribution closer to Normal, if possible. A General Linear Model (GLM) analysis will be used to identify whether any change in the NPI score is associated with any change in the PainChek® pain score over the same period, as well as any demographic or baseline characteristics of the participants. The characteristics which will be explored for possible association with change in NPI score will include: gender, age group, and documented chronic pain. Further, descriptive statistics (eg, mean, median) will be used to summarise the study participants (2A and 2B) 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
1/06/2020
Actual
Date of last data collection
Anticipated
31/12/2020
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 302693 0
University
Name [1] 302693 0
Curtin University
Country [1] 302693 0
Australia
Funding source category [2] 302695 0
Commercial sector/Industry
Name [2] 302695 0
PainChek Ltd (formerly known as EPAT Technologies)
Country [2] 302695 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] 302623 0
Commercial sector/Industry
Name [1] 302623 0
PainChek Ltd (formerly known as EPAT Technologies)
Address [1] 302623 0
Suite 401, 35 Lime St,
Sydney NSW 2000,
Country [1] 302623 0
Australia
Other collaborator category [1] 280681 0
Charities/Societies/Foundations
Name [1] 280681 0
Dementia Support Australia (DSA)
Address [1] 280681 0
Suite 17A
151 Herdsman Parade
Wembley, 6014
Country [1] 280681 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303306 0
Human Research Ethics Committee (HREC), Curtin University
Ethics committee address [1] 303306 0
Ethics committee country [1] 303306 0
Australia
Date submitted for ethics approval [1] 303306 0
02/05/2019
Approval date [1] 303306 0
Ethics approval number [1] 303306 0

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

Contacts
Principal investigator
Name 93214 0
Prof Jeff Hughes
Address 93214 0
School of Pharmacy
Curtin University
GPO Box U1987
Perth Western Australia 6845
Country 93214 0
Australia
Phone 93214 0
+618 9266 7367
Fax 93214 0
+618 9266 2769
Email 93214 0
J.D.Hughes@curtin.edu.au
Contact person for public queries
Name 93215 0
Areej Hussein
Address 93215 0
School of Pharmacy
Curtin University
GPO Box U1987
Perth Western Australia 6845
Country 93215 0
Australia
Phone 93215 0
+61497853956
Fax 93215 0
Email 93215 0
a.hussein1@postgrad.curtin.edu.au
Contact person for scientific queries
Name 93216 0
Areej Hussein
Address 93216 0
School of Pharmacy
Curtin University
GPO Box U1987
Perth Western Australia 6845
Country 93216 0
Australia
Phone 93216 0
+61497853956
Fax 93216 0
Email 93216 0
a.hussein1@postgrad.curtin.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
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.