JIA Toolbox Feasibility Study

NCT07543575 | Active Not Recruiting DMC

• 1 other identifier: SCH-2851
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Juvenile Idiopahtic Arthritis

Outcome Measures

Primary Outcomes (12)

• 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

Study Arms (1)

Children and young people with a diagnosis of Juvenile Idiopathic arthritis

EXPERIMENTAL

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)

Interventions

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.

Children and young people with a diagnosis of Juvenile Idiopathic arthritis

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.

Children and young people with a diagnosis of Juvenile Idiopathic arthritis

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

Children and young people with a diagnosis of Juvenile Idiopathic arthritis

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheffield Children's NHS Foundation Trust: lead
• Sheffield Hallam University: collaborator

Study Sites (1)

Sheffield Children's NHS Foundation Trust

Sheffield, S10 2TH, United Kingdom

Location

Study Officials

• Ursula Ankeny

  Sheffield Children's NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: April 22, 2026
• Study Start: May 21, 2024
• Primary Completion: February 28, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 22, 2026

Record last verified: 2025-05

Locations

GB (1)