JIA Toolbox Feasibility Study

• Research type

  Research Study

• Full title

  JIA (Juvenile Idiopathic Arthritis) Toolbox Feasibility Study

• IRAS ID

  336429

• Contact name

  Ursula Ankeny

• Contact email

  u.ankeny@shu.ac.uk

• Sponsor organisation

  Sheffield Children's NHS Foundation Trust

• Duration of Study in the UK

  0 years, 8 months, 16 days

• Research 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

  This application is seeking ethics for WP 4&5&6. From this point on, 'the study' will refer to these WP’s.

  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.

• REC name

  East Midlands - Nottingham 1 Research Ethics Committee

• REC reference

  24/EM/0057

• Date of REC Opinion

  9 Apr 2024

• REC opinion

  Further Information Favourable Opinion