Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:47 PM
Study NCT ID:
NCT05563194
Status:
COMPLETED
Last Update Posted:
2023-06-08
First Post:
2022-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proof-of-concept Study of 'JIA Toolbox' for Children and Young People (CYP) With Juvenile Idiopathic Arthritis (JIA)
Sponsor:
Sheffield Children's NHS Foundation Trust
Organization:
Study Overview
Official Title:
Exploring the Potential of 'JIA Toolbox' in Improving the Independence and Functional Ability of Children and Young People (CYP) With Juvenile Idiopathic Arthritis (JIA)
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
JIA Toolbox
Brief 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.
'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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: