Juvenile Idiopahtic ArthritisNCT07543575
JIA Toolbox Feasibility Study
A study testing Heating prototype (Prototype 1), Physio tool (Prototype 2) and Communication tool (Prototype 3) in people with Juvenile Idiopahtic Arthritis, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Juvenile Idiopathic Arthritis (JIA) is a long-term rheumatic disease affecting approximately 15,000 children and young people (CYP) in the UK. JIA causes ongoing/long-term joint inflammation, pain, and stiffness, making everyday activities difficult. Read more about this study
- Who is it for?
- Ages 7 to 16 years
- Conditions the study is for
- Juvenile Idiopahtic Arthritis
- What is being tested?
- Heating prototype (Prototype 1), Physio tool (Prototype 2) and Communication tool (Prototype 3)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 May 2024to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 7- 16 years (minimum age is 7 to ensure participants can adequately engage with the prototypes and describe their experience)
- Diagnosis of JIA
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Children's NHS Foundation Trust
Sheffield, S10 2TH
About this study
Official title: JIA (Juvenile Idiopathic Arthritis) Toolbox Feasibility Study
Juvenile Idiopathic Arthritis (JIA) is a long-term rheumatic disease affecting approximately 15,000 children and young people (CYP) in the UK. 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. CYP with JIA find current product aids difficult to use, stigmatising and patronising.
This project follows on from a previous successful proof-of-concept study in 2021, involving initial testing on 10 CYP over 9 weeks. These results established that the prototypes addressed an unmet need and worked well. We now propose a feasibility study involving 25 children using the prototypes over 3 months to assess their suitability and further develop an evidence base. The prototypes - 'JIA Toolbox'- consist of three prototypes that collectively aim to improve CYP's independence and functional ability.
Read more
This project consists of 6 Work Packages (WP):
WP1: Post application and pre-award start WP2: Design and development WP3: Production of final prototypes WP4: Recruitment of participants WP5: Feasibility intervention period WP6: Data analysis and dissemination
The feasibility study aims to test the effectiveness and viability of 'JIA Toolbox' in improving CYP with JIA's independence, functional ability, and therefore overall condition management. The study will involve recruiting 25 CYP with JIA aged 7-16 and their parent/guardian from Sheffield Children's Hospital. Baseline data on CYP's lived experience of JIA will be collected over 2 weeks, through self-reporting. They will then use the prototypes for 3 months.
Lived experience data on condition management will continue to be self-reported and the prototypes will collect usage data independently. Post-intervention data will then be collected for a further 2 weeks. Interviews will then be conducted to further capture study experience.
Read the detailed description
Juvenile idiopathic arthritis (JIA) is the most frequently occurring rheumatic disease of childhood, causing ongoing joint inflammation, pain and stiffness making everyday activities difficult. Studies have emphasised the significant negative impacts JIA has across physical, social, psychological and educational development.
Key stakeholder groups (CYP with JIA, their parents, healthcare professionals and teachers) were active participants throughout our previous work, through co-design workshops, surveys and a proof-of-concept study. Key highlighted clinical need was assistance with self-management. This is broken down into the following specific unmet needs:
Pain-management. Improved pain management would enable CYP to do more of the things they love, by providing a solution that they can use independently as and when is needed, positively impacting their wellbeing.
Physiotherapy adherence as currently CYP often do not do clinician-recommended exercises. Improved compliance with recommended physiotherapy interventions may reduce pain in the long-term and improve mobility.
Communication between the pupil and teacher. Improving this communication would provide CYP with a way to discreetly access necessary support without facing stigma, improving their concentration by removing anxiety around accessing help.
JIA Toolbox is a co-designed innovation, consisting of three assistive device prototypes that aim to collectively improve condition self-management. Each prototype helps with the afore-mentioned specific unmet needs
- Conditions
- Juvenile Idiopahtic Arthritis
- Being tested
- Heating prototype (Prototype 1), Physio tool (Prototype 2), Communication tool (Prototype 3)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Physio tool (Prototype 2)Device
A motivational physiotherapy tool that gamifies physio, as the CYP do their prescribed stretches, emphasising a sense of progression and making it a more engaging activity
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, without attracting the attention of their classmates, reducing embarrassment.
| Study group | Role | What they receive |
|---|---|---|
| Children and young people with a diagnosis of Juvenile Idiopathic arthritis | Experimental | Single arm study where all participants will receive the three prototype interventions. Receives: Device: Heating prototype (Prototype 1); Device: Physio tool (Prototype 2); Device: Communication tool (Prototype 3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-management of JIA Questionnaire
Changes in the participants ability to self-manage their condition independently and confidently. Assessed through daily questionnaires throughout the duration of the study. These will be combined with other outcomes to assess against the baseline and post-intervention points for changes, as in the previous proof-of-concept study which used the same measures.
Measured: baseline, week 16
Change in self-management of JIA Data
Changes in the participants ability to self-manage their condition independently and confidently. Assessed through data (frequency of use, settings chosen) from the prototypes throughout the duration of the study. These will be combined with other outcomes to assess against the baseline and post-intervention points for changes, as in the previous proof-of-concept study which used the same measures.
Measured: baseline, week 16
Change in self-management of JIA Interview
Changes in the participants ability to self-manage their condition independently and confidently. Assessed through interviews at the end of the study. These will be combined with other outcomes to assess against the baseline and post-intervention points for changes, as in the previous proof-of-concept study which used the same measures.
Measured: week 16
Change in functional ability Questionnaire
Changes in ability across physical, emotional, social and educational spheres. Assessed through daily questionnaires throughout the duration of the study. These will be combined with other outcomes to assess against the baseline and post-intervention points for changes, as in the previous proof-of-concept study which used the same measures.
Measured: baseline, week 16
Change in functional ability Data
Changes in ability across physical, emotional, social and educational spheres. Assessed through data (frequency of use, settings chosen) from the prototypes throughout the duration of the study. These will be combined with other outcomes to assess against the baseline and post-intervention points for changes, as in the previous proof-of-concept study which used the same measures.
Measured: baseline, week 16
Change in functional ability Interview
Changes in ability across physical, emotional, social and educational spheres. Assessed through interviews at the end of the study. These will be combined with other outcomes to assess against the baseline and post-intervention points for changes, as in the previous proof-of-concept study which used the same measures.
Measured: week 16
Change in physio adherence Questionnaire
Change in frequency of participants undertaking recommended physio stretches. Assessed through daily questionnaires throughout the duration of the study. These will be combined with other outcomes to assess against the baseline and post-intervention points for changes, as in the previous proof-of-concept study which used the same measures.
Measured: baseline, week 16
Change in physio adherence Data
Change in frequency of participants undertaking recommended physio stretches. Assessed through data (frequency of use, settings chosen) from the prototypes throughout the duration of the study. These will be combined with other outcomes to assess against the baseline and post-intervention points for changes, as in the previous proof-of-concept study which used the same measures.
Measured: baseline, week 16
Change in physio adherence Interview
Change in frequency of participants undertaking recommended physio stretches. Assessed through interviews at the end of the study. These will be combined with other outcomes to assess against the baseline and post-intervention points for changes, as in the previous proof-of-concept study which used the same measures.
Measured: week 16
Change in pain-management Questionnaire
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. These will be combined with other outcomes to assess against the baseline and post-intervention points for changes, as in the previous proof-of-concept study which used the same measures.
Measured: baseline, week 16
Change in pain-management Data
Change in participants ability to manage joint pain during a flare up using prototype 1. Assessed through data on prototype 1 (frequency of use, settings chosen). These will be combined with other outcomes to assess against the baseline and post-intervention points for changes, as in the previous proof-of-concept study which used the same measures.
Measured: baseline, week 16
Change in pain-management Interview
Change in participants ability to manage joint pain during a flare up using prototype 1. Assessed through interviews at the end of the study. These will be combined with other outcomes to assess against the baseline and post-intervention points for changes, as in the previous proof-of-concept study which used the same measures.
Measured: week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start21 May 2024
- Primary completion28 Feb 2026
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopahtic ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Sheffield Hallam University
- Responsible party
- Sponsor
- Investigators
- Ursula Ankeny, Principal investigator, Sheffield Children's NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543575
- Sponsor's protocol ID
- SCH-2851
- Status last verified
- May 2025
- First submitted
- 8 May 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- JIA (Juvenile Idiopathic Arthritis) Toolbox Feasibility Study
- ClinicalTrials.gov ID
- NCT07543575
- Acronym / sponsor ID
- SCH-2851
- Conditions
- Juvenile Idiopahtic Arthritis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Sheffield Children's NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Sheffield Hallam University
- Study start
- 21 May 2024 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Juvenile Idiopathic Arthritis (JIA) is a long-term rheumatic disease affecting approximately 15,000 children and young people (CYP) in the UK. 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. CYP with JIA find current product aids difficult to use, stigmatising and patronising.
This project follows on from a previous successful proof-of-concept study in 2021, involving initial testing on 10 CYP over 9 weeks. These results established that the prototypes addressed an unmet need and worked well. We now propose a feasibility study involving 25 children using the prototypes over 3 months to assess their suitability and further develop an evidence base. The prototypes - 'JIA Toolbox'- consist of three prototypes that collectively aim to improve CYP's independence and functional ability.
This project consists of 6 Work Packages (WP):
WP1: Post application and pre-award start WP2: Design and development WP3: Production of final prototypes WP4: Recruitment of participants WP5: Feasibility intervention period WP6: Data analysis and dissemination
The feasibility study aims to test the effectiveness and viability of 'JIA Toolbox' in improving CYP with JIA's independence, functional ability, and therefore overall condition management. The study will involve recruiting 25 CYP with JIA aged 7-16 and their parent/guardian from Sheffield Children's Hospital. Baseline data on CYP's lived experience of JIA will be collected over 2 weeks, through self-reporting. They will then use the prototypes for 3 months.
Lived experience data on condition management will continue to be self-reported and the prototypes will collect usage data independently. Post-intervention data will then be collected for a further 2 weeks. Interviews will then be conducted to further capture study experience.
Detailed description
Juvenile idiopathic arthritis (JIA) is the most frequently occurring rheumatic disease of childhood, causing ongoing joint inflammation, pain and stiffness making everyday activities difficult. Studies have emphasised the significant negative impacts JIA has across physical, social, psychological and educational development.
Key stakeholder groups (CYP with JIA, their parents, healthcare professionals and teachers) were active participants throughout our previous work, through co-design workshops, surveys and a proof-of-concept study. Key highlighted clinical need was assistance with self-management. This is broken down into the following specific unmet needs:
Pain-management. Improved pain management would enable CYP to do more of the things they love, by providing a solution that they can use independently as and when is needed, positively impacting their wellbeing.
Physiotherapy adherence as currently CYP often do not do clinician-recommended exercises. Improved compliance with recommended physiotherapy interventions may reduce pain in the long-term and improve mobility.
Communication between the pupil and teacher. Improving this communication would provide CYP with a way to discreetly access necessary support without facing stigma, improving their concentration by removing anxiety around accessing help.
JIA Toolbox is a co-designed innovation, consisting of three assistive device prototypes that aim to collectively improve condition self-management. Each prototype helps with the afore-mentioned specific unmet needs
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children and young people with a diagnosis of Juvenile Idiopathic arthritis | Experimental | Device: Heating prototype (Prototype 1), Device: Physio tool (Prototype 2), Device: Communication tool (Prototype 3)Single arm study where all participants will receive the three prototype interventions. |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Aged 7- 16 years (minimum age is 7 to ensure participants can adequately engage with the prototypes and describe their experience)
- Diagnosis of JIA
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Children and young people with a diagnosis of Juvenile Idiopathic arthritis |
| Physio tool (Prototype 2)A motivational physiotherapy tool that gamifies physio, as the CYP do their prescribed stretches, emphasising a sense of progression and making it a more engaging activity | Device | Children and young people with a diagnosis of Juvenile Idiopathic arthritis |
| 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, without attracting the attention of their classmates, reducing embarrassment. | Device | Children and young people with a diagnosis of Juvenile Idiopathic arthritis |
Primary outcome
Change in self-management of JIA Questionnaire
Time frame: baseline, week 16
Changes in the participants ability to self-manage their condition independently and confidently. Assessed through daily questionnaires throughout the duration of the study. These will be combined with other outcomes to assess against the baseline and post-intervention points for changes, as in the previous proof-of-concept study which used the same measures.
Change in self-management of JIA Data
Time frame: baseline, week 16
Changes in the participants ability to self-manage their condition independently and confidently. Assessed through data (frequency of use, settings chosen) from the prototypes throughout the duration of the study. These will be combined with other outcomes to assess against the baseline and post-intervention points for changes, as in the previous proof-of-concept study which used the same measures.
Change in self-management of JIA Interview
Time frame: week 16
Changes in the participants ability to self-manage their condition independently and confidently. Assessed through interviews at the end of the study. These will be combined with other outcomes to assess against the baseline and post-intervention points for changes, as in the previous proof-of-concept study which used the same measures.
Change in functional ability Questionnaire
Time frame: baseline, week 16
Changes in ability across physical, emotional, social and educational spheres. Assessed through daily questionnaires throughout the duration of the study. These will be combined with other outcomes to assess against the baseline and post-intervention points for changes, as in the previous proof-of-concept study which used the same measures.
Change in functional ability Data
Time frame: baseline, week 16
Changes in ability across physical, emotional, social and educational spheres. Assessed through data (frequency of use, settings chosen) from the prototypes throughout the duration of the study. These will be combined with other outcomes to assess against the baseline and post-intervention points for changes, as in the previous proof-of-concept study which used the same measures.
Change in functional ability Interview
Time frame: week 16
Changes in ability across physical, emotional, social and educational spheres. Assessed through interviews at the end of the study. These will be combined with other outcomes to assess against the baseline and post-intervention points for changes, as in the previous proof-of-concept study which used the same measures.
Change in physio adherence Questionnaire
Time frame: baseline, week 16
Change in frequency of participants undertaking recommended physio stretches. Assessed through daily questionnaires throughout the duration of the study. These will be combined with other outcomes to assess against the baseline and post-intervention points for changes, as in the previous proof-of-concept study which used the same measures.
Change in physio adherence Data
Time frame: baseline, week 16
Change in frequency of participants undertaking recommended physio stretches. Assessed through data (frequency of use, settings chosen) from the prototypes throughout the duration of the study. These will be combined with other outcomes to assess against the baseline and post-intervention points for changes, as in the previous proof-of-concept study which used the same measures.
Change in physio adherence Interview
Time frame: week 16
Change in frequency of participants undertaking recommended physio stretches. Assessed through interviews at the end of the study. These will be combined with other outcomes to assess against the baseline and post-intervention points for changes, as in the previous proof-of-concept study which used the same measures.
Change in pain-management Questionnaire
Time frame: baseline, week 16
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. These will be combined with other outcomes to assess against the baseline and post-intervention points for changes, as in the previous proof-of-concept study which used the same measures.
Change in pain-management Data
Time frame: baseline, week 16
Change in participants ability to manage joint pain during a flare up using prototype 1. Assessed through data on prototype 1 (frequency of use, settings chosen). These will be combined with other outcomes to assess against the baseline and post-intervention points for changes, as in the previous proof-of-concept study which used the same measures.
Change in pain-management Interview
Time frame: week 16
Change in participants ability to manage joint pain during a flare up using prototype 1. Assessed through interviews at the end of the study. These will be combined with other outcomes to assess against the baseline and post-intervention points for changes, as in the previous proof-of-concept study which used the same measures.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ursula Ankeny principal investigator
Sheffield Children's NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heating prototype (Prototype 1), Physio tool (Prototype 2) and Communication tool (Prototype 3) in people with Juvenile Idiopahtic Arthritis, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-management of JIA Questionnaire (time frame: baseline, week 16). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.