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Trial registered on ANZCTR


Registration number
ACTRN12616000665437
Ethics application status
Approved
Date submitted
13/05/2016
Date registered
23/05/2016
Date last updated
15/09/2024
Date data sharing statement initially provided
30/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Development and Delivery of an Integrated Digital Health Care Approach for Children With Juvenile Idiopathic Arthritis
Scientific title
Development and Delivery of an Integrated Digital Health Care Approach for Children With Juvenile Idiopathic Arthritis
Secondary ID [1] 289216 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Juvenile Idiopathic Arthritis 298775 0
Condition category
Condition code
Inflammatory and Immune System 298828 298828 0 0
Autoimmune diseases
Musculoskeletal 298862 298862 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Customised Smart Watch programme:
The chief investigator will set up discrete prompts / messages during the day through the smart-watch device to inform the child with JIA to record daily pain level fluctuations (using the iVAS App recently developed by Dr Coda and his research team) and to document when the prescribed drugs have been taken by simply ‘tapping’ the smart-watch to confirm when the measurement has been acquired.
Three discreet prompts per day will be automatically sent to the child with JIA to record pain, at waking, midday and evenings. The inbuilt accelerometer and GPS within the smart-watch allows for the simultaneous gathering of the intensity of physical activity outcome. World Health Organisation (WHO), US Centre for Disease Control, US Surgeon General, American Heart Foundation, US Department of Health & Human Services, and the National Heart Foundation of Australia all recommend individuals take 10,000 steps a day to improve their health and reduce the risk of disease. 10,000 steps a day is a realistic goal that is achievable by people of all shapes, sizes and ages. When daily physical activity targets set by the research are achieved, the child will be informed via a gentle vibration on the wrist, and notified of their achievements with positive reinforcement messages and ‘awards-icons’ on their smart-watch screen. The physical activity targets will be set by the chief investigator for each participant for a period of 6 months, which may vary based on symptoms severity and overall health conditions.
The participants will be kindly asked to wear the smart watch during the whole day; however, it will not be required to wear the device during sleeping time, which enable the watch to be re-recharged.
All the notifications received by the child will be accessible remotely by the parents as well, in oder to help and support the child towards improving the self-management of the pathology. The child will be informed that the smart watch cannot be worn in certain conditions, such as showering and swimming. The child and the parent will be informed to record water physical activities carried out by the child and to notify the chief investigator with a simple free-messaging system. Under these circumstances the chief-investigator will translate the equivalent of swimming carried out into calories & exercise level, and directly update the individual customised program.
Intervention code [1] 294754 0
Treatment: Devices
Comparator / control treatment
The standard watch will be provided to the JIA children randomly allocated to the control group.
The watch supplied to the control group will have same appearance as the smart watch (in the trial group); however it will not have any 'smart' functionality. The standard watch screen will only provide the time.
Control group
Active

Outcomes
Primary outcome [1] 298296 0
Change in lower limb pain as recorded by the iVAS app developed by the Dr Coda and his research and also by comparing it with the standard VAS (visual analogue scale). According to Dhanani et al. (2002), 8mm are required to achieve clinical significance difference between data collection sessions, in paediatric rheumatology children.
Timepoint [1] 298296 0
baseline
3rd months
6th months
Primary outcome [2] 298297 0
Change in 'Quality of life' using the ‘disease specific’ (paediatric rheumatology) - PedsQL questionnaire divided according to the age range (gathered directly by the child and independently also by their parents / carer). According to Varni et al (2002), 5 points are required to achieve clinical significance difference between data collection sessions
Timepoint [2] 298297 0
baseline
3rd month
6th month
Secondary outcome [1] 323819 0
Changes in drug therapy compliancy will be assessed comparing the weekly drug prescribed (frequencies and dosages) by the paediatric rheumatologists to the actual drug intake from the child with JIA (frequencies and dosages) in both groups by self-report by participant using study medication diary.
Timepoint [1] 323819 0
baseline
3rd month
6th month
Secondary outcome [2] 323820 0
Change in exercise adherence level will be compared using a validated tool called ActivPal device (extensively used in research) that is able to blindly campure physical activity (ie: walking distance, steps,). Both groups will be supplied with an ActivPAL, (attached on the right thigh) which will be returned to the data collector after 7 days, using the provided pre paid envelope (along with the ActivPAL device). Data collected will be downloaded to the ActivPal software and then analysed. This methodological approach will be the essential to compare the effectiveness of the customised watch programme versus the control group with regards to basic physical activity activity levels during the 6 months trial period,
Timepoint [2] 323820 0
baseline
3rd month
6th month

Eligibility
Key inclusion criteria
1) Diagnosed with JIA according to ILAR (International League of Associations for Rheumatology) criteria.
2) No previous use of Apple-Watch
3) Resident in Australia
Minimum age
10 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Concomitant musculoskeletal disease, central or peripheral nerve disease
2) Heart failure
3) Severe visual impairments
4) If DMARD and/or Biological therapy are used, not having started these drug therapies within 6 months of enrolling in the trial.
5) Where assistive drugs therapy administration is required daily by medical staff

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)
Data collector will use sealed opaque envelopes for allocation concealments into a control or active group
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/04/2025
Actual
Date of last participant enrolment
Anticipated
30/07/2025
Actual
Date of last data collection
Anticipated
1/11/2025
Actual
Sample size
Target
58
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 293598 0
Self funded/Unfunded
Name [1] 293598 0
None at the moment
Country [1] 293598 0
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 292413 0
None
Name [1] 292413 0
NA
Address [1] 292413 0
NA
Country [1] 292413 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295038 0
Human Ethics Research Committee, University of Newcastle
Ethics committee address [1] 295038 0
University Drive
Callaghan NSW 2308
Ethics committee country [1] 295038 0
Australia
Date submitted for ethics approval [1] 295038 0
09/01/2017
Approval date [1] 295038 0
15/01/2018
Ethics approval number [1] 295038 0
NA

Summary
Brief summary
Our novel clinical approach could place innovative non-drug treatment solutions in the hands of children with Juvenile Idiopathic Arthritis (JIA). This multi centre randomised control-trial aims to integrate the Smart Watch to monitor pain levels, customised physical activity progression, and drug-therapy adherence in children with JIA.
Trial website
Trial related presentations / publications
Public notes
To support the development of the interventions that is being used in this clinical trial, a feasibility study, and a usability study was conducted, to ensure the intervention worked as intended and supported a user-centred design.
Ethics approval for these studies was granted by the Hunter New England Research Ethics Committee (ref no: 2019/ETH01035).

Contacts
Principal investigator
Name 65862 0
Dr Andrea Coda
Address 65862 0
Lecturer in Podiatry - PhD, Hons (BSc) Pod
The University of Newcastle, School of Health Sciences, Faculty of Health and Medicine - Health Precinct, BE154, PO Box 127. Ourimbah, NSW, 2258, Australia.
Country 65862 0
Australia
Phone 65862 0
+61 2 4348 4000
Fax 65862 0
Email 65862 0
[email protected]
Contact person for public queries
Name 65863 0
Andrea Coda
Address 65863 0
Lecturer in Podiatry - PhD, Hons (BSc) Pod
The University of Newcastle, School of Health Sciences, Faculty of Health and Medicine - Health Precinct, BE154, PO Box 127. Ourimbah, NSW, 2258, Australia.
Country 65863 0
Australia
Phone 65863 0
+61 2 4348 4000
Fax 65863 0
Email 65863 0
[email protected]
Contact person for scientific queries
Name 65864 0
Andrea Coda
Address 65864 0
Lecturer in Podiatry - PhD, Hons (BSc) Pod
The University of Newcastle, School of Health Sciences, Faculty of Health and Medicine - Health Precinct, BE154, PO Box 127. Ourimbah, NSW, 2258, Australia.
Country 65864 0
Australia
Phone 65864 0
+61 2 4348 4000
Fax 65864 0
Email 65864 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


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.