JIA Toolbox Feasibility Study

JIA (Juvenile Idiopathic Arthritis) 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Juvenile Idiopahtic Arthritis
• Intervention / Treatment: Device: Heating prototype (Prototype 1); Device: Physio tool (Prototype 2); Device: Communication tool (Prototype 3)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Sheffield, United Kingdom, S10 2TH
    • Sheffield Children's NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Children and young people with a diagnosis of Juvenile Idiopathic arthritis; Single arm study where all participants will receive the three prototype interventions.

Device: Heating prototype (Prototype 1); 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.; Device: Physio tool (Prototype 2); 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; Device: Communication tool (Prototype 3); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in self-management of JIA Questionnaire	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.	baseline, week 16
Change in self-management of JIA Data	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.	baseline, week 16
Change in self-management of JIA Interview	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.	week 16
Change in functional ability Questionnaire	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.	baseline, week 16
Change in functional ability Data	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.	baseline, week 16
Change in functional ability Interview	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.	week 16
Change in physio adherence Questionnaire	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.	baseline, week 16
Change in physio adherence Data	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.	baseline, week 16
Change in physio adherence Interview	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.	week 16
Change in pain-management Questionnaire	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.	baseline, week 16
Change in pain-management Data	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.	baseline, week 16
Change in pain-management Interview	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.	week 16

Collaborators and Investigators

• Sponsor: Sheffield Children's NHS Foundation Trust
• Collaborators: Sheffield Hallam University
• Investigators: Principal Investigator: Ursula Ankeny, Sheffield Children's NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2024
• Primary Completion (Actual): February 28, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: May 8, 2025
• First Submitted That Met QC Criteria: April 15, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: SCH-2851

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No