An interventional study of Heating prototype (Prototype 1) and Physio tool (Prototype 2) in Rheumatologic Disease, sponsored by Sheffield Children's NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 7 Years to 16 Years. Per ClinicalTrials.gov, last updated 2023-06-08.
Sponsored by Sheffield Children's NHS Foundation Trust · Not applicable, Interventional, and Supportive care
This project aims to further develop and conduct a 'real-world' proof-of-concept assessment of a suite of three products, known as the 'JIA Toolbox', that collectively aim to improve CYP's independence and functional ability
'JIA Toolbox' targets key unmet needs identified by stakeholders during our previous work. Each prototype (Appendix1) addresses a specific unmet need:
The project is at a stage where the prototypes need their potential value assessed through a proof-of-concept study. A co-design approach, involving CYP with JIA, their parents, their teachers and HCPs, will be maintained throughout to ensure the outcomes are meaningful. This study will begin with co-design workshops to develop the current prototypes further, followed by a qualitative study assessing the real-world usability, acceptability and potential impacts of these prototypes; testing them with real users in their homes. The project aims to make a positive contribution to CYP with JIA by improving their independence and functional ability through co-designed therapeutic interventions.
Juvenile Idiopathic Arthritis (JIA) is a long-term rheumatic disease affecting approximately 15,000 children and young people (CYP) in the UK [1] with 1,000-1,500 new diagnoses/year. JIA causes ongoing/long-term joint inflammation, pain, and stiffness, making everyday activities difficult. JIA has been shown to impact physical, social, emotional, and educational development. Products exist to aid tasks such as writing, washing, and eating. However, a survey we conducted in 2018 showed that CYP with JIA find these products difficult to use, stigmatising, and patronising. Furthermore, these products often neglect to consider the wider stakeholder network and how their support, or lack of it, impacts the child's overall wellbeing.
This project aims to further develop and conduct a 'real-world' proof-of-concept assessment of a suite of three products, known as the 'JIA Toolbox', that collectively aim to improve CYP's independence and functional ability
'JIA Toolbox' targets key unmet needs identified by stakeholders during our previous work. Each prototype (Appendix1) addresses a specific unmet need:
The project is at a stage where the prototypes need their potential value assessed through a proof-of-concept study. A co-design approach, involving CYP with JIA, their parents, their teachers and HCPs, will be maintained throughout to ensure the outcomes are meaningful. This study will begin with co-design workshops to develop the current prototypes further, followed by a qualitative study assessing the real-world usability, acceptability and potential impacts of these prototypes; testing them with real users in their homes. The project aims to make a positive contribution to CYP with JIA by improving their independence and functional ability through co-designed therapeutic interventions.
352 studies on the registry are indexed under Arthritis, Juvenile; 92 are open to participants now.
This study's enrollment of 10 is below the median of 50 across 225 interventional studies indexed under Arthritis, Juvenile.
Browse Arthritis, Juvenile studies →Sheffield Children's NHS Foundation Trust is the lead sponsor of 51 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single arm study where all participants will receive the three prototype interventions.
Device: Heating prototype (Prototype 1) · Device: Physio tool (Prototype 2) · Device: Communication tool (Prototype 3)
A wearable that heats and vibrates to help distract from pain. It can be wrapped around any joint with temperature and vibration settings allowing CYP to set the device to their needs.
A motivational physiotherapy tool that incrementally lights up as the CYP do their prescribed stretches, emphasising a sense of progression and making it a more engaging activity.
A wearable to help communication in the classroom between the teacher and pupil. The child can alert the teacher if they need help, through vibration, without attracting the attention of their classmates, reducing embarrassment.
Change in self-management of JIA
Changes in the participants ability to self-manage their condition independently and confidently. Assessed through daily questionnaires throughout the duration of the study, data (frequency of use, settings chosen) from the prototypes, and a post-intervention interview with participants.
Time frame: Baseline, Week 9
Change in functional ability
Changes in ability across physical, emotional, social and educational spheres. Assessed through daily questionnaires throughout the duration of the study, data (frequency of use, settings chosen) from the prototypes, and a post-intervention interview with participants.
Time frame: Baseline, Week 9
Change in physio adherence
Change in frequency of participants undertaking recommended physio stretches. Assessed through daily questionnaires throughout the duration of the study, data (frequency of use, settings chosen) from the prototypes, and a post-intervention interview with participants
Time frame: Baseline, Week 9
Change in pain-management
Change in participants ability to manage joint pain during a flare up using prototype 1. Assessed through daily questionnaires throughout the duration of the study, data on prototype 1 (frequency of use, settings chosen), and a post-intervention interview with participants.
Time frame: Baseline, Week 9
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sheffield Children's NHS Foundation Trust