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Development and Delivery of an Integrated Digital Health Care Approach for Children With Juvenile Idiopathic Arthritis

Development and Delivery of an Integrated Digital Health Care Approach for Children With Juvenile Idiopathic Arthritis

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000665437
Enrollment
58
Registered
2016-05-23
Start date
2025-04-02
Completion date
2025-07-30
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 chil

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.

Sponsors

The University of Newcastle
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)

Eligibility

Sex/Gender
All
Age
10 Years to 18 Years
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026