Proof-of-concept Study of 'JIA Toolbox' for Children and Young People (CYP) With Juvenile Idiopathic Arthritis (JIA) (JIA Toolbox)

Exploring the Potential of 'JIA Toolbox' in Improving the Independence and Functional Ability of Children and Young People (CYP) With Juvenile Idiopathic Arthritis (JIA)

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 Overview

• Status: Completed
• Conditions: Rheumatologic Disease
• Intervention / Treatment: Device: Heating prototype (Prototype 1); Device: Physio tool (Prototype 2); Device: Communication tool (Prototype 3)

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Sheffield, United Kingdom, S10 2TH
    • Sheffield Children's NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 16 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged 7- 16 years (minimum age is 7 to ensure participants can adequately engage with the prototypes and describe their experience)
• Diagnosis of JIA
• Currently managed within SCH Rheumatology Service
• Fluent in verbal and written English
• Access to a computer with an internet connection to facilitate virtual co-design workshops due to the COVID-19 pandemic

Exclusion Criteria:

• Aged <7 years or >16 years
• Non-fluent in verbal and written English
• Diagnosis of autistic spectrum disorder (ASD)
• Children with medically unexplained pain, pain amplification syndromes or other pain disorder
• Co-existing joint or muscle disorder other than JIA

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Children and young people with a diagnosis of Juvenile Idiopathic arthritis; Single arm study where all participants will receive the three prototype 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 incrementally lights up 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, through vibration, without attracting the attention of their classmates, reducing embarrassment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in self-management of JIA	Changes in the participants ability to self-manage their condition independently and confidently. Assessed through daily questionnaires throughout the duration of the study, data (frequency of use, settings chosen) from the prototypes, and a post-intervention interview with participants.	Baseline, Week 9
Change in functional ability	Changes in ability across physical, emotional, social and educational spheres. Assessed through daily questionnaires throughout the duration of the study, data (frequency of use, settings chosen) from the prototypes, and a post-intervention interview with participants.	Baseline, Week 9
Change in pain-management	Change in participants ability to manage joint pain during a flare up using prototype 1. Assessed through daily questionnaires throughout the duration of the study, data on prototype 1 (frequency of use, settings chosen), and a post-intervention interview with participants.	Baseline, Week 9
Change in physio adherence	Change in frequency of participants undertaking recommended physio stretches. Assessed through daily questionnaires throughout the duration of the study, data (frequency of use, settings chosen) from the prototypes, and a post-intervention interview with participants	Baseline, Week 9

Collaborators and Investigators

• Sponsor: Sheffield Children's NHS Foundation Trust
• Investigators: Study Director: Ursula Ankeny, Sheffiled Hallam University

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2022
• Primary Completion (Actual): February 15, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: September 21, 2022
• First Submitted That Met QC Criteria: September 28, 2022
• First Posted (Actual): October 3, 2022

Study Record Updates

• Last Update Posted (Actual): June 8, 2023
• Last Update Submitted That Met QC Criteria: June 6, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Arthritis; Rheumatic Diseases; Collagen Diseases; Arthritis, Juvenile
• Other Study ID Numbers: SCH-2628

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No