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Active, Not Recruiting

NCT Number: NCT07543575

JIA Toolbox Feasibility Study

Juvenile Idiopathic Arthritis (JIA) is a long-term rheumatic disease affecting approximately 15,000 children and young people (CYP) in the UK. 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. CYP with JIA find current product aids difficult to use, stigmatising and patronising.

This project follows on from a previous successful proof-of-concept study in 2021, involving initial testing on 10 CYP over 9 weeks. These results established that the prototypes addressed an unmet need and worked well. We now propose a feasibility study involving 25 children using the prototypes over 3 months to assess their suitability and further develop an evidence base. The prototypes - 'JIA Toolbox'- consist of three prototypes that collectively aim to improve CYP's independence and functional ability.

This project consists of 6 Work Packages (WP):

WP1: Post application and pre-award start WP2: Design and development WP3: Production of final prototypes WP4: Recruitment of participants WP5: Feasibility intervention period WP6: Data analysis and dissemination

The feasibility study aims to test the effectiveness and viability of 'JIA Toolbox' in improving CYP with JIA's independence, functional ability, and therefore overall condition management. The study will involve recruiting 25 CYP with JIA aged 7-16 and their parent/guardian from Sheffield Children's Hospital. Baseline data on CYP's lived experience of JIA will be collected over 2 weeks, through self-reporting. They will then use the prototypes for 3 months.

Lived experience data on condition management will continue to be self-reported and the prototypes will collect usage data independently. Post-intervention data will then be collected for a further 2 weeks. Interviews will then be conducted to further capture study experience.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Juvenile Idiopahtic Arthritis

Age range

7 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheffield Children's NHS Foundation Trust

Sheffield, S10 2TH, United Kingdom

About this study

Juvenile idiopathic arthritis (JIA) is the most frequently occurring rheumatic disease of childhood, causing ongoing joint inflammation, pain and stiffness making everyday activities difficult. Studies have emphasised the significant negative impacts JIA has across physical, social, psychological and educational development.

Key stakeholder groups (CYP with JIA, their parents, healthcare professionals and teachers) were active participants throughout our previous work, through co-design workshops, surveys and a proof-of-concept study. Key highlighted clinical need was assistance with self-management. This is broken down into the following specific unmet needs:

Pain-management. Improved pain management would enable CYP to do more of the things they love, by providing a solution that they can use independently as and when is needed, positively impacting their wellbeing.

Physiotherapy adherence as currently CYP often do not do clinician-recommended exercises. Improved compliance with recommended physiotherapy interventions may reduce pain in the long-term and improve mobility.

Communication between the pupil and teacher. Improving this communication would provide CYP with a way to discreetly access necessary support without facing stigma, improving their concentration by removing anxiety around accessing help.

JIA Toolbox is a co-designed innovation, consisting of three assistive device prototypes that aim to collectively improve condition self-management. Each prototype helps with the afore-mentioned specific unmet needs

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 7- 16 years (minimum age is 7 to ensure participants can adequately engage with the prototypes and describe their experience)
  • Diagnosis of JIA
  • Fluent in verbal and written English
  • Access to a computer with an internet connection to facilitate virtual co-design workshops due to the COVID-19 pandemic

Exclusion criteria

  • Aged <7 years or >16 years
  • Non-fluent in verbal and written English
  • Diagnosis of autistic spectrum disorder (ASD)
  • Children with medically unexplained pain, pain amplification syndromes or other pain disorder
  • Co-existing joint or muscle disorder other than JIA

Treatment and study plan

Heating prototype (Prototype 1)

Device

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.

Physio tool (Prototype 2)

Device

A motivational physiotherapy tool that gamifies physio, as the CYP do their prescribed stretches, emphasising a sense of progression and making it a more engaging activity

Communication tool (Prototype 3)

Device

A wearable to help communication in the classroom between the teacher and pupil. The child can alert the teacher if they need help, without attracting the attention of their classmates, reducing embarrassment.

Primary outcomes

  1. Change in self-management of JIA Questionnaire

    Time frame: baseline, week 16

    Changes in the participants ability to self-manage their condition independently and confidently. Assessed through daily questionnaires throughout the duration of the study. These will be combined with other outcomes to assess against the baseline and post-intervention points for changes, as in the previous proof-of-concept study which used the same measures.

  2. Change in self-management of JIA Data

    Time frame: baseline, week 16

    Changes in the participants ability to self-manage their condition independently and confidently. Assessed through data (frequency of use, settings chosen) from the prototypes throughout the duration of the study. These will be combined with other outcomes to assess against the baseline and post-intervention points for changes, as in the previous proof-of-concept study which used the same measures.

  3. Change in self-management of JIA Interview

    Time frame: week 16

    Changes in the participants ability to self-manage their condition independently and confidently. Assessed through interviews at the end of the study. These will be combined with other outcomes to assess against the baseline and post-intervention points for changes, as in the previous proof-of-concept study which used the same measures.

  4. Change in functional ability Questionnaire

    Time frame: baseline, week 16

    Changes in ability across physical, emotional, social and educational spheres. Assessed through daily questionnaires throughout the duration of the study. These will be combined with other outcomes to assess against the baseline and post-intervention points for changes, as in the previous proof-of-concept study which used the same measures.

  5. Change in functional ability Data

    Time frame: baseline, week 16

    Changes in ability across physical, emotional, social and educational spheres. Assessed through data (frequency of use, settings chosen) from the prototypes throughout the duration of the study. These will be combined with other outcomes to assess against the baseline and post-intervention points for changes, as in the previous proof-of-concept study which used the same measures.

  6. Change in functional ability Interview

    Time frame: week 16

    Changes in ability across physical, emotional, social and educational spheres. Assessed through interviews at the end of the study. These will be combined with other outcomes to assess against the baseline and post-intervention points for changes, as in the previous proof-of-concept study which used the same measures.

  7. Change in physio adherence Questionnaire

    Time frame: baseline, week 16

    Change in frequency of participants undertaking recommended physio stretches. Assessed through daily questionnaires throughout the duration of the study. These will be combined with other outcomes to assess against the baseline and post-intervention points for changes, as in the previous proof-of-concept study which used the same measures.

  8. Change in physio adherence Data

    Time frame: baseline, week 16

    Change in frequency of participants undertaking recommended physio stretches. Assessed through data (frequency of use, settings chosen) from the prototypes throughout the duration of the study. These will be combined with other outcomes to assess against the baseline and post-intervention points for changes, as in the previous proof-of-concept study which used the same measures.

  9. Change in physio adherence Interview

    Time frame: week 16

    Change in frequency of participants undertaking recommended physio stretches. Assessed through interviews at the end of the study. These will be combined with other outcomes to assess against the baseline and post-intervention points for changes, as in the previous proof-of-concept study which used the same measures.

  10. Change in pain-management Questionnaire

    Time frame: baseline, week 16

    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. These will be combined with other outcomes to assess against the baseline and post-intervention points for changes, as in the previous proof-of-concept study which used the same measures.

  11. Change in pain-management Data

    Time frame: baseline, week 16

    Change in participants ability to manage joint pain during a flare up using prototype 1. Assessed through data on prototype 1 (frequency of use, settings chosen). These will be combined with other outcomes to assess against the baseline and post-intervention points for changes, as in the previous proof-of-concept study which used the same measures.

  12. Change in pain-management Interview

    Time frame: week 16

    Change in participants ability to manage joint pain during a flare up using prototype 1. Assessed through interviews at the end of the study. These will be combined with other outcomes to assess against the baseline and post-intervention points for changes, as in the previous proof-of-concept study which used the same measures.

Sponsors and collaborators

Lead sponsor

Sheffield Children's NHS Foundation Trust

Other

Collaborators

  • Sheffield Hallam University

Registry information

Official study title

JIA (Juvenile Idiopathic Arthritis) Toolbox Feasibility Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 22, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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