Proof-of-concept Study of 'JIA Toolbox' for Children and Young People (CYP) With Juvenile Idiopathic Arthritis (JIA)
Condition: Rheumatologic Disease
MeSH terms: Arthritis, Juvenile; Rheumatic Diseases; Collagen Diseases
Study type: Interventional

Summary: 
      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:

        1. Prototype-1: Pain which stops CYP doing the things they love;

        2. Prototype-2: Difficulty for healthcare professionals (HCPs) to motivate CYP to do
           stretches;

        3. Prototype-3: Communication difficulties between teachers and CYP

      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.
    

Detailed description: 
      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:

        1. Prototype-1: Pain which stops CYP doing the things they love;

        2. Prototype-2: Difficulty for healthcare professionals (HCPs) to motivate CYP to do
           stretches;

        3. Prototype-3: Communication difficulties between teachers and CYP

      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.
    

Intervention name(s): Heating prototype (Prototype 1); Physio tool (Prototype 2); Communication tool (Prototype 3)
Intervention type(s): Device; Device; Device
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care