JIA Toolbox Feasibility Study

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

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.

Sponsors & Collaborators

• Sheffield Hallam University

  collaborator OTHER

• Sheffield Children's NHS Foundation Trust

  lead OTHER

Principal Investigators

• Ursula Ankeny · Sheffield Children's NHS Foundation Trust

Study Design

Allocation

NA

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

7 Years

Max Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-21

Primary Completion

2026-02-28

Completion

2026-05-31

Countries

• United Kingdom

Study Locations