Proof-of-concept Study of 'JIA Toolbox' for Children and Young People (CYP) With Juvenile Idiopathic Arthritis (JIA) (JIA Toolbox)
Primary Purpose
Rheumatologic Disease
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Heating prototype (Prototype 1)
Physio tool (Prototype 2)
Communication tool (Prototype 3)
Sponsored by
About this trial
This is an interventional supportive care trial for Rheumatologic Disease
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
Sites / Locations
- Sheffield Children's NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Children and young people with a diagnosis of Juvenile Idiopathic arthritis
Arm Description
Single arm study where all participants will receive the three prototype interventions.
Outcomes
Primary Outcome Measures
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.
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.
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05563194
First Posted
September 21, 2022
Last Updated
June 6, 2023
Sponsor
Sheffield Children's NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT05563194
Brief Title
Proof-of-concept Study of 'JIA Toolbox' for Children and Young People (CYP) With Juvenile Idiopathic Arthritis (JIA)
Acronym
JIA Toolbox
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)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
August 15, 2022 (Actual)
Primary Completion Date
February 15, 2023 (Actual)
Study Completion Date
March 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Children's NHS Foundation Trust
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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:
Prototype-1: Pain which stops CYP doing the things they love;
Prototype-2: Difficulty for healthcare professionals (HCPs) to motivate CYP to do stretches;
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:
Prototype-1: Pain which stops CYP doing the things they love;
Prototype-2: Difficulty for healthcare professionals (HCPs) to motivate CYP to do stretches;
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatologic Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Children and young people with a diagnosis of Juvenile Idiopathic arthritis
Arm Type
Experimental
Arm Description
Single arm study where all participants will receive the three prototype interventions.
Intervention Type
Device
Intervention Name(s)
Heating prototype (Prototype 1)
Intervention Description
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
Intervention Name(s)
Physio tool (Prototype 2)
Intervention Description
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
Intervention Name(s)
Communication tool (Prototype 3)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in self-management of JIA
Description
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.
Time Frame
Baseline, Week 9
Title
Change in functional ability
Description
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.
Time Frame
Baseline, Week 9
Title
Change in physio adherence
Description
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
Time Frame
Baseline, Week 9
Title
Change in pain-management
Description
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.
Time Frame
Baseline, Week 9
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ursula Ankeny
Organizational Affiliation
Sheffiled Hallam University
Official's Role
Study Director
Facility Information:
Facility Name
Sheffield Children's NHS Foundation Trust
City
Sheffield
ZIP/Postal Code
S10 2TH
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Proof-of-concept Study of 'JIA Toolbox' for Children and Young People (CYP) With Juvenile Idiopathic Arthritis (JIA)
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