Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05563194 |
| Other study ID # |
SCH-2628 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 15, 2022 |
| Est. completion date |
March 31, 2023 |
Study information
| Verified date |
June 2023 |
| Source |
Sheffield Children's NHS Foundation Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This project aims to further develop and conduct a 'real-world' proof-of-concept assessment
of a suite of three products, known as the 'JIA Toolbox', that collectively aim to improve
CYP's independence and functional ability
'JIA Toolbox' targets key unmet needs identified by stakeholders during our previous work.
Each prototype (Appendix1) addresses a specific unmet need:
1. Prototype-1: Pain which stops CYP doing the things they love;
2. Prototype-2: Difficulty for healthcare professionals (HCPs) to motivate CYP to do
stretches;
3. Prototype-3: Communication difficulties between teachers and CYP
The project is at a stage where the prototypes need their potential value assessed through a
proof-of-concept study. A co-design approach, involving CYP with JIA, their parents, their
teachers and HCPs, will be maintained throughout to ensure the outcomes are meaningful. This
study will begin with co-design workshops to develop the current prototypes further, followed
by a qualitative study assessing the real-world usability, acceptability and potential
impacts of these prototypes; testing them with real users in their homes. The project aims to
make a positive contribution to CYP with JIA by improving their independence and functional
ability through co-designed therapeutic interventions.
Description:
Juvenile Idiopathic Arthritis (JIA) is a long-term rheumatic disease affecting approximately
15,000 children and young people (CYP) in the UK [1] with 1,000-1,500 new diagnoses/year. 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. Products exist to aid tasks such as writing, washing, and eating. However, a
survey we conducted in 2018 showed that CYP with JIA find these products difficult to use,
stigmatising, and patronising. Furthermore, these products often neglect to consider the
wider stakeholder network and how their support, or lack of it, impacts the child's overall
wellbeing.
This project aims to further develop and conduct a 'real-world' proof-of-concept assessment
of a suite of three products, known as the 'JIA Toolbox', that collectively aim to improve
CYP's independence and functional ability
'JIA Toolbox' targets key unmet needs identified by stakeholders during our previous work.
Each prototype (Appendix1) addresses a specific unmet need:
1. Prototype-1: Pain which stops CYP doing the things they love;
2. Prototype-2: Difficulty for healthcare professionals (HCPs) to motivate CYP to do
stretches;
3. Prototype-3: Communication difficulties between teachers and CYP
The project is at a stage where the prototypes need their potential value assessed through a
proof-of-concept study. A co-design approach, involving CYP with JIA, their parents, their
teachers and HCPs, will be maintained throughout to ensure the outcomes are meaningful. This
study will begin with co-design workshops to develop the current prototypes further, followed
by a qualitative study assessing the real-world usability, acceptability and potential
impacts of these prototypes; testing them with real users in their homes. The project aims to
make a positive contribution to CYP with JIA by improving their independence and functional
ability through co-designed therapeutic interventions.
