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

NCT ID: NCT05563194

Last Updated: 2023-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-15
• Study Completion Date: 2023-03-31

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.

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.

Conditions

Rheumatologic Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Children and young people with a diagnosis of Juvenile Idiopathic arthritis

Single arm study where all participants will receive the three prototype interventions.

Group Type: EXPERIMENTAL

Heating prototype (Prototype 1)

Intervention Type: DEVICE

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.

Physio tool (Prototype 2)

Intervention Type: DEVICE

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.

Communication tool (Prototype 3)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheffield Children's NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ursula Ankeny

Role: STUDY_DIRECTOR

Sheffiled Hallam University

Locations

Sheffield Children's NHS Foundation Trust

Sheffield, , United Kingdom

Countries

United Kingdom

Other Identifiers

SCH-2628

Identifier Type: -

Identifier Source: org_study_id