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JIA Toolbox Feasibility Study

NCT:NCT07543575 · ACTIVE_NOT_RECRUITING

NCT IDNCT07543575
狀態ACTIVE_NOT_RECRUITING
開始日期2024-05-21
完成時間2026-05-31

簡要摘要

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.

官方來源

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