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

NCT05563194 | Completed

• 1 other identifier: SCH-2628
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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. 1.Prototype-1: Pain which stops CYP doing the things they love;
2. 2.Prototype-2: Difficulty for healthcare professionals (HCPs) to motivate CYP to do stretches;
3. 3.Prototype-3: Communication difficulties between teachers and CYP

Conditions

Rheumatologic Disease

Outcome Measures

Primary Outcomes (4)

• 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 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

• 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

Study Arms (1)

Children and young people with a diagnosis of Juvenile Idiopathic arthritis

EXPERIMENTAL

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

Device: Heating prototype (Prototype 1); Device: Physio tool (Prototype 2); Device: Communication tool (Prototype 3)

Interventions

Heating prototype (Prototype 1) 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.

Children and young people with a diagnosis of Juvenile Idiopathic arthritis

Physio tool (Prototype 2) 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.

Children and young people with a diagnosis of Juvenile Idiopathic arthritis

Communication tool (Prototype 3) 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.

Children and young people with a diagnosis of Juvenile Idiopathic arthritis

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheffield Children's NHS Foundation Trust: lead

Study Sites (1)

Sheffield Children's NHS Foundation Trust

Sheffield, S10 2TH, United Kingdom

Location

MeSH Terms

Conditions

Collagen Diseases

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ursula Ankeny

  Sheffiled Hallam University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: October 3, 2022
• Study Start: August 15, 2022
• Primary Completion: February 15, 2023
• Study Completion: March 31, 2023
• Last Updated: June 8, 2023

Record last verified: 2023-06

Locations

GB (1)