JIA (Juvenile Idiopathic Arthritis) Toolbox Feasibility Study
Phase: NA
Conditions: Juvenile Idiopahtic Arthritis
Sponsor: Sheffield Children's NHS Foundation Trust

 
 
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Protocol 
 
JIA (Juvenile Idiopathic Arthritis) Toolbox Feasibility Study 
 
JIA Toolbox Feasibility Study 
 
18/12/2024 Version 2 
 
IRAS number: 336429 
 
 
The undersigned confirm that the following protocol has been agreed and accepted and that 
the Chief Investigator agrees to conduct the study in compliance with the approved protocol 
and will adhere to the principles outlined in the Declaration of Helsinki, the Sponsor’s SOPs, 
and other regulatory requirement. 
 
I agree to ensure that the confidential information contained in this document will not be 
used for any other purpose other than the evaluation or conduct of the investigation 
without the prior written consent of the Sponsor 
 
I also confirm that I will make the findings of the study publicly available through publication 
or other dissemination tools without any unnecessary delay and that an honest accurate and 
transparent account of the study will be given; and that any discrepancies from the study as 
planned in this protocol will be explained. 
 
 
KEY STUDY CONTACTS 
Chief Investigator 
Ursula Ankeny (Design Researcher at SHU), 
u.ankeny@shu.ac.uk 07762323084 
Sponsor 
Meena Balasubramanian, 
meena.balasubramanian@nhs.net, 01142717000 
Funder(s) 
Medical Research Council (MRC IAA 2023 Call) 
Co-Investigator 
Dr Daniel Hawley (Consultant Paediatric 
Rheumatologist at SCH), daniel.hawley@nhs.net, 
07834153509 
Co-Investigator 
Catherine Dunbar (Occupational Therapist at SCH), 
c.dunbar@nhs.net 
Co-Investigator 
Dr Joe Langley (Principal Research Fellow at SHU), 
j.langley@shu.ac.uk, 07760882488 
Co-Investigator 
Nick Dulake (Researcher and product designer at 
SHU) n.dulake@shu.ac.uk 
Advisor 
Richard Beesley (Director of Juvenile Arthritis 
Research (JAR) charity) 

 
 
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STUDY SUMMARY 
 
Study Title 
JIA Toolbox Feasibility Study 
Internal ref. no. (or short title) 
JIA Toolbox Feasibility Study 
Study Participants 
Children with JIA (aged 7-16), their parents and 
their teachers 
Planned Size of Sample (if applicable) 
N=25 
Planned Study Period 
9 months (08.04.24 – 31.07.25) 
Research Question/Aim(s) 
 
What are the potential impacts of using 'JIA 
Toolbox' for: 
- Children and Young People (CYP) with Juvenile 
Idiopathic Arthritic (JIA) in terms of improving 
overall condition management by enabling 
independence and improved functional ability? 
- Parents of CYP with JIA in terms of enabling 
improved condition management? 
- Healthcare Professionals (HCP's) working in JIA 
management in terms of improving physio 
adherence? 
- and teachers of children with JIA in terms of 
improving communication around the condition in 
the classroom? 
 
 
 
The Research Team and expertise: 
 
CI: Ursula Ankeny – Design Researcher and Product Designer. Expertise in co-designing 
technological healthcare solutions and delivering multiple healthcare research projects.  
CO-I: Daniel Hawley – Consultant Paediatric Rheumatologist. Expertise in treating and 
managing Juvenile Idiopathic Arthritis and delivering healthcare research projects.  
CO-I: Catherine Dunbar – Specialist Paediatric Rheumatology Occupational Therapist. 
Expertise in working with children with JIA on their occupational needs and therefore areas 
of difficulty that are unmet by current products and delivering healthcare research projects.  
CO-I: Nick Dulake – Industrial Designer and design researcher. Expertise in designing and 
prototyping products for industry, including electronic, sensor and textile-based solutions, 
and delivering a variety of health related research projects.  
CO-I: Joe Langley – Principal Research Fellow. Expertise in design and co-design as methods 
of applied Research and Knowledge Mobilisation in the field of Health and Wellbeing. 
 

 
 
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The team is highly experienced in: 
- 
Translational research, 
- 
Patient focused research, 
- 
Co-designing solutions, 
- 
Developing products, services and interventions that promote dignity and enhance 
quality of life, 
- 
And commercialisation of solutions – example ‘head-up’ neck collar (designed, 
developed and currently on the market) and recently awarded global ‘Made With 
Patients’ award. 
 
 
 
 
 
 
 
 
 
 
 
 
 
Protocol 
 
1.0 Lay Summary 
 
This is a 12-month feasibility study to test the effectiveness and viability of a group of 3 
assistive devices to help improve independence and functional ability for children and young 
people (CYP) with Juvenile Idiopathic Arthritis (JIA). These devices have been extensively co-
designed with CYP with JIA, their parents, healthcare professionals and teachers, ensuring 
they provide solutions to priority unmet needs within the JIA community. The devices have 
already undergone a successful proof-of-concept study. This feasibility project aims to assess 
the effectiveness and viability of the devices in a real-world setting over a longer time-frame 
and with a larger cohort. 
 
2.0 Background 
 
This study aims to assess the potential impacts of ‘JIA Toolbox’, (Appendix1) – three novel 
prototypes that collectively aim to improve the independence and functional ability of 
Children and Young People (CYP) with Juvenile Idiopathic Arthritis (JIA).  
 
‘JIA Toolbox’ addresses key unmet needs identified by stakeholders during previous work. 
Each prototype (Appendix1) addresses a specific unmet need: 
 

 
 
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UNMET NEED: Joint pain that prevents CYP from doing activities they love. 
PROTOTYPE 1 SOLUTION: a wearable pain management device that heats and vibrates to 
help distract the brain from pain based on the idea of gate theory. 
 
UNMET NEED: CYP don't engage with their physio as they find it boring and frustrating due 
to perceived lack of progress. This therefore creates ongoing strained and frustrated 
relationships with parents and HCP's. 
PROTOTYPE 2 SOLUTION: a motivational physiotherapy tool that incrementally lights up in 
response to the stretches helping CYP visualise and 'see' progress.   
 
UNMET NEED: CYP often need help in the classroom but are too embarrassed to put their 
hand up as they don't want everyone to know about their condition. This can lead to feelings 
of disbelief from the teacher and a strained relationship between pupil and teacher. 
PROTOTYPE 3 SOLUTION: a communication wearable for school that silently vibrates to alert 
the teacher to difficulty enabling better communication and combatting feelings of disbelief. 
 
Our previous proof-of-concept study received positive feedback, prompting the drive to 
refine the prototypes and continue with a feasibility study. Our work aims to improve 
outcomes for CYP with JIA by empowering and equipping them: to self-manage confidently 
and independently, to harness their wider support network when necessary and to embed 
positive health behaviours from a young age. 
1,000-1,500 CYP are diagnosed with JIA every year [2]. It affects CYP’s lives, “impacting on 
relationships, school, physical and individual domains” [4] due to “chronic or recurrent pain 
and disability” [3]. Widespread lack of understanding often makes CYP with JIA feel isolated, 
e.g. “There will always be a teacher who responds to me being tired, with: ‘I also get tired, 
but still got to do stuff’” [6]. There are products designed to support CYP with JIA but they 
have limitations and our previous work shows they are not sensitive to user needs. ‘JIA 
Toolbox’ has been developed using a co-design approach with CYP, parents/guardians, HCPs 
and teachers to ensure that it meets key stakeholder needs and is therefore more likely to 
be adopted by patients and clinical services.  
 
A major priority for health services is helping people with long-term conditions (LTC’s), 
including arthritis, as highlighted in the 2030 Agenda for Sustainable Development. LTC’s 
such as JIA can be life-limiting with emotionally and physically debilitating effects. Longer 
term, JIA can restrict access to employment, putting increased pressure on the economy and 
healthcare resources. Developing self-management skills from a young age is crucial to 
managing chronic illness. Equipping CYP to become confident in managing their own 
condition is particularly important as CYP transition from children’s to adults’ services.  
 
COVID-19 highlighted the importance of effective self-management as healthcare resources 
were diverted to support COVID-19. This withdrawal of, or limited access to, key support can 
have a negative impact on the physical and mental wellbeing of CYP with LTC’s. The 
development of self-management tools such as ‘JIA Toolbox’ is key to help 
relieve pressure on healthcare professionals and alleviate concerns of patients. The wider, 
informal stakeholder support networks surrounding each patient such as teachers are also 

 
 
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an integral part of condition management. However, they remain an under used resource. In 
part, this is due to the lack of appropriate resources (tools, knowledge, information, power) 
to support CYP in seeking help from such people and in part, due to a lack of appropriate 
resources (tools, knowledge, information, empathy) that enable these people to provide 
relevant kinds of support. The tools in ‘JIA Toolbox’ aim to fill this gap. This is novel, relevant 
and potentially transferrable to other chronic conditions. 
 
Existing studies describing the experience of living with JIA [3-6] tend to focus exclusively on 
one stakeholder’s experience or on the physical symptoms, neglecting both the wider life 
impact and insights of other stakeholders. This study will therefore provide contemporary 
data on CYPs experiences of living with JIA to inform future research.  
 
3.0 Clinical need 
 
Juvenile Idiopathic Arthritis (JIA) is a paediatric long-term condition affecting approximately 
15,000 children and young people (CYP) in the UK, with 1,000-1,5000 new diagnoses each 
year. It causes ongoing joint inflammation, pain and stiffness, making everyday activities 
difficult. It affects every aspect of CYP's lives, impacting on physical, social, emotional and 
education development, with widespread lack of understanding often making CYP with JIA 
feel isolated. There are products designed to support CYP with JIA but they have limitations 
and our previous work (a survey and co-design process conducted in 2018) shows they are 
not sensitive to user needs. Our survey highlighted that CYP with JIA find these products 
difficult to use as most therapeutic aids are targeted towards an adult population. The few 
that are aimed at children were seen as patronising and stigmatising. These products also 
often neglect to take into account the wider stakeholder network such as parents, teachers 
and healthcare professionals, and therefore neglects to support them in helping CYP with 
JIA.  
 
Key stakeholder groups (CYP with JIA, their parents, healthcare professionals and teachers) 
were active participants throughout our previous work, through co-design workshops and 
surveys. The 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 
 
As a result, 'JIA Toolbox' was co-designed and developed to fulfil these needs and previously 
tested on a cohort of n=10 CYP with JIA during a proof-of-concept study. The results from 

 
 
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the proof-of-concept study were successful with 80% of participants finding one or more of 
the prototypes beneficial for their condition management.  
 
The aim of this study is therefore to further refine the prototypes based on participant 
feedback and then test their effectiveness and viability over a longer time frame (3 months) 
with a larger cohort (n=25) in improving overall condition management in terms of improved 
independence and functional ability. The data collected will therefore be: experiences of 
living with JIA both with and without 'JIA Toolbox' and prototype use patterns to build up a 
strong evidence based on the effectiveness and viability of these devices, enabling a good 
point from which to leverage further funding. 
 
4.0 Study Objectives and Purpose 
 
This is a feasibility study assessing the effectiveness and viability of Juvenile Idiopathic 
Arthritis (JIA)Toolbox in improving overall condition management by improving Children and 
Young People's (CYP's) independence and functional ability. 
 
Each prototype was developed to address an unmet need and therefore has a specific aim: 
• Prototype 1: A wearable device that aims to promote pain self-management skills; 
• Prototype 2: A motivational tool that aims to improve physiotherapy engagement; 
• Prototype 3: A wearable device that aims to promote discrete communication 
between CYP and teachers and other stakeholders. 
 
The primary objective of this study is to explore the potential impact of ‘JIA Toolbox’ in 
addressing the unmet needs identified by stakeholders by conducting a feasibility study to 
explore the usage of the three prototypes and their impact on CYP’s independence and 
functional ability. 
 
The secondary objective is to collect contemporary data on CYP’s experiences of living with 
JIA to inform future research and innovation. 
 
5.0 Study Design 
 
CYP aged 7-16 years with JIA, parents/guardians and HCPs based at Sheffield Children’s 
Hospital (SCH) and/or a part of Juvenile Arthritis Research (JAR) charity will participate 
throughout this study.  
 
The components of ‘JIA Toolbox’ are illustrated in Appendix1. The potential impact of these 
devices will be assessed by comparing baseline qualitative data about living with JIA, with 
data collected when the devices are in use. Post-intervention interviews with participants 
will capture practical usability issues and the potential impact of ‘JIA Toolbox’ on CYP’s wider 
life, like social impact, to frame possible outcome measures for future evaluation. 
 
The study design is shown in Appendix 2. It will consist of: 
 

 
 
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WP4 
4.1 Recruitment of participants n=25 (CYP aged 7-16) and their parents/guardian from SCH 
or JAR 
4.2 Consenting processes 
 
WP5 
5.1 Prototype testing by clinical engineering 
5.2 Virtual training session on data collection processes for participants (1 hour) 
5.3 Baseline data collection period (2 weeks) 
5.4 In person training session on prototypes (1- 1.5 hours) 
5.5 Intervention period using prototypes (3 months) 
5.6 ‘JIA Toolbox’ returned to SCH 
5.7 post-intervention data collection period (2 weeks) 
5.8 End of intervention interview (1 hour 1:1 with researcher) 
 
WP6 
6.1 Analyse qualitative data with healthcare professionals who are a part of the research 
team 
 
The end of study is defined as the date of the last interview of the last participant. 
As ‘JIA Toolbox’ consists of therapeutic self-management tools, participants will decide when 
to use the prototypes during the 3-month intervention period. As such, there should be no 
added burden to the participants in using these products, as they are designed to assist with 
condition management rather than hinder. There will be two training sessions, one on how 
to use the data collection packs (examples shown in appendix 3) and one on how to use the 
prototypes. This will ensure that the participants are clear on what they should do, 
minimising any potential risks in interacting with the prototypes. There will be regular 
weekly check ins to ensure participants are happy with the study and to troubleshoot any 
issues raised. The 3-month intervention period where the participants are using the devices 
will take place over August, September and October, giving CYP 1 month to get used to the 
devices prior to using them in a school context. From the previous proof-of-concept study, it 
was highlighted that the devices were beneficial in building CYP-teacher relationship near 
the beginning of the school year. Post-intervention interviews will be conducted at the end 
of the study to ensure all experiences are equally captured and to give participants the 
opportunity to highlight anything they feel needs additional clarification.  
 
The study design has had input from YOUR RHEUM which is a group of CYP (11-24) with 
diagnosed rheumatic conditions, and JAR which is a group of CYP (7-25) with Juvenile 
Arthritis. Both groups regularly input on CYP rheumatology research. They have a strong 
track-record in advising on and shaping rheumatology research and represent a ‘Gold 
Standard’ approach to PPI involvement. These groups have been involved in shaping the 
study design and participant facing materials such as the data collection packs to ensure 
they are appropriate and will be effective. They have also commented on the prototypes 
themselves, feeling that they fulfill key unmet needs within the JIA population. Daniel 
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rheumatology and come into regular contact with CYP with JIA. They are both members of 
the project team and have been involved in planning the study design, utilising their 
extensive knowledge of the condition to ensure it is appropriate and capturing useful data. 
This project is being funded by Medical Research Council and as such, had to go through a 
rigorous application process. 
 
6.0 Participant Recruitment 
 
The study will recruit from SCH Rheumatology service. Daniel Hawley (DH) or CD will initially 
approach potential participants using a recruitment flyer (shown in appendix 2) for context 
(also available through SCH Rheumatology Facebook group). Interested participants will be 
screened by clinical members of the study team and given a participant information sheet 
(shown in appendix 5,6,7,8). Following this, they will give verbal consent for Ursula Ankeny 
(Principal Investigator) to call them for any queries. A consent form (shown in appendix 9, 10 
and 11) will then be emailed to be signed and sent back.  
 
The study will also recruit from JAR charity. They have a group of members who have agreed 
to be contacted about research opportunities. The process would involve me sending the 
recruitment poster to JAR which they would circulate among their members. JAR would then 
send an email with a form to fill in to register interest. This form would ask for details around 
the child’s age (to check eligibility) and other inclusion criteria as well as their contact details 
which by submitting the form they would agree to be shared with UA. That list would then 
be sent to UA, who would then call each interested participant and if they would like to take 
part UA would then send through the Participant information sheets. After reading the PIS, if 
they would like to join the study UA will then send them the consent form for them to sign 
and return. UA has spoken with the director of JAR, Richard Beesley who is happy with this 
approach. 
 
The process for recruiting and consenting teachers hinges upon which CYP have consented 
to be involved, as it is their teacher(s) that will need to be recruited. Once interested CYP 
and their parent/guardian have been consented. UA or CD will approach the CYP's school/ 
teacher with a recruitment flyer for context. If interested, they will be given a participant 
information sheet. If they wish to proceed, a call will be arranged with the study lead UA for 
any queries. A consent form will then be emailed to be signed and sent back. If their 
teachers do not want to participate, this will still be useful data as it speaks to adoption of 
the intended prototypes. However, it is expected that at least 50% of CYP's teachers will 
engage with the study as the prototypes are designed to assist them in their role, in terms of 
helping and communicating with CYP. Based on the proof-of-concept study 100% of CYP’s 
teacher’s engaged, and we therefore expect similar engagement. 
 
Families who participate in the study will receive a £50 ‘thank you’ voucher recognising their 
time and involvement. The participation gift will be mentioned in the participant information 
sheet, once the participants have expressed an initial interest in WP4, after seeing the flyer. 
Teachers will not receive financial renumeration due to the fact that the prototype 

 
 
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pertaining to them is designed to assist duties that fall within the remit of their role in terms 
of helping and communicating with CYP.   
 
Recruitment flyers, participant information sheets, consent and assent forms are shown in 
Appendix (5,6,7,8,9,10 and 11). 
 
6.1 Selection of Participants 
 
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 experiencing JIA symptoms 
• 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 
 
We have excluded CYP with ASD because it can affect sensory processing including the 
interpretation of pain and may also affect how CYP are able to communicate. We have 
excluded CYP with other pain disorders because this would likely behave and respond 
differently to pain associated with JIA. We have excluded CYP with any co-existing joint or 
muscle disorder other than JIA because these may behave or respond differently to 
symptoms associated with JIA. 
 
7.0 Data handling and record keeping 
 
The use of personal addresses, emails and telephone numbers will be used to send potential 
participants information on the study, these will not be seen or used outside of the clinical 
care team until participants have consented and given the researcher their preferred 
method of contact. 
 
All research data will be collected confidentially and as per Appendix 15: data sharing 
agreement, identifiable data will be stored on encrypted NHS servers. All identifiable data  
will be password protected to ensure maximum security, which only the research team will 
have access to. The data will then be anonymised and transferred to q:/ Drive on the 

 
 
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Sheffield Hallam University server which will only be accessible by the SHU research team. It 
will be transferred from nhs.net account to nhs.net account to ensure sufficient security is 
maintained. The Q drive is SHU’s Research Store service and provides shared storage for 
currently active research projects. Data is backed up automatically on a daily basis and can 
be fully recovered in the case of accidents. All backups are securely kept on two remote 
locations for a period of 90 days. Access to all folders is restricted to researchers, students 
and external partners working on the project.  Password-protection will be used on all data 
files to ensure only the research team have access. 
 
Participants will consent to the use of photography video recording for the study, they will 
be made aware that no images taken will be used for dissemination or publicity without 
their further consent. 
 
8.0 Access to source data 
 
The sponsor will permit monitoring and audits by the relevant authorities, including the 
Health Research Authority and Research Ethics Committee.  The investigator will also allow 
monitoring and audits by these bodies and the sponsor, and they will provide direct access 
to source data and documents.   
 
9.0 Statistical Analysis 
 
As this is a qualitative feasibility study, a sample size of 25 is adequate according to Lancaster 
et al as supported by NIHR when estimating a parameter within a study. This study is testing 
the effectiveness and viability of ‘JIA Toolbox’, we are looking at the practicalities of using 
these prototypes in real contexts and seeking clues as to the potential real-life impacts, by 
way of specifying further product design refinements and as a way of understanding how a 
future pilot evaluation study might be practically designed and which outcome measures 
would be relevant to service users, HCPs and device manufacturers. 
 
At the conclusion of this study, the STOP/GO criteria for continuing onto a larger study will 
be:  
• green light if 50% report a positive change in their condition management,  
• amber light requiring potential changes if 30% report a positive change and,  
• red light if only 10% report a positive change.  
 
10.0 Safety Assessment 
 
The study will be monitored and audited in accordance with the Monitoring Standard 
Operating Procedures of the Directorate of Research & Innovation at Sheffield Children’s 
NHS Foundation Trust.  All study related documents will be available on request for 
monitoring and audits by the Sponsor, the Health Research Authority and the relevant 
Research Ethics Committee. 
 
Further information is provided in the risk assessment form 

 
 
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11.0 Ethical Considerations 
 
1. Risk of unintended distress 
Discussion with participants about JIA will be treated sensitively. Interviews may lead to 
minor distress. To minimise this risk, participants will be informed they do not have to 
complete any questions or take part in any activities that make them uncomfortable and 
reminded that they have the right to withdraw at any point and will still receive their thank 
you voucher. If a participant becomes distressed, the session will be ended sensitively but 
quickly. Any participant who has shown evidence of distress will be discussed with the study 
clinicians (DH/CD). The rheumatology team has a clinical psychologist who could be involved 
if significant distress is felt to have occurred, although it is not anticipated this will be 
needed. 
 
2. Burden of time 
Involvement is optional and participants will receive a 'thank you' voucher. The use of the 
prototypes is designed to fit around day-to-day activities and to assist rather than be a 
burden. Difficulty in using the products will be minimised through training and weekly check 
ins where the project team can trouble shoot any queries.  
 
3. Concern that they can't withdraw 
Before each part of the study, participants, parents and guardians will be informed that this 
is a voluntary research study and they are free to withdraw at any point and it will not affect 
their future healthcare.  
 
4. Risk of unintentionally worsening symptoms 
The prototypes are designed to help improve symptoms and are based upon proven 
therapies and known and tested technologies that are routinely used in other products on 
the market, therefore this risk is minimal. Based on the proof-of-concept study, the 
prototypes were seen as beneficial to symptom manage and did not make any participants 
symptoms worse. 
 
5. Using the prototypes 
The prototypes are electronic devices and as such could potentially pose a risk to 
participants. Firstly, in the previous proof-of-concept study there were no safety issues with 
the devices. Secondly, the devices for this study will be manufactured by CPI, who have an 
extensive track record of creating safe, efficient and high quality health tech devices. Thirdly, 
before using the prototypes, a 1 hour training session will be set up with CI Ursula Ankeny to 
ensure the participants feel confident in using them. The prototypes themselves will use 
known and tested technologies that are routinely used in other products on the market and 
therefore the risk of danger is minimal. For prototype 1 which uses a carbon fibre heating 
element, there will be sensors incorporated into the device which will stop the device if 
needed to ensure it does not overheat. 
 
12.0 Justification of finance and resources 

 
 
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UA time (1 day a week over 18 months (£16,362): Although PI, UA is the only person who 
can do this work as it builds on the previous background work of which she has sole and 
extensive knowledge (specifically relating to the underpinning research, design and 
development of the prototypes and experience in developing innovations for the JIA 
population).  
 
Sheffield Hallam University in kind contribution: 
- 
Dr Joe Langley (CO-I): Advising on ethics/research approvals, design aspects, PPIE 
sessions and general applicable queries as the project develops. 
- 
Nick Dulake (CO-I): Consulting on prototype improvements, design and prototype 
assistance, technical assistance and ongoing advising of related aspects. 
 
Sheffield Children’s Hospital in kind contribution:  
- 
Dr Daniel Hawley (CO-I): Project planning, review of patient information sheets, 
identification and recruitment of patient participants. 
- 
Catherine Dunbar (CO-I): Review of patient information sheets, identification and 
recruitment of patient participants. 
 
PPIE sessions with YOUR RHEUM (£1,200) and JAR (Juvenile Arthritis Charity) (£2000):  To 
advise and steer the research at an early stage by CYP with JIA and their families, and input 
on study design and participant facing materials where appropriate to ensure maximum 
engagement from the participants involved. 
 
‘Thank you' vouchers (£50 per participant (30) = £1500): for participant time to 
acknowledge participant contribution to encourage engagement.  
 
Technical equipment (£3000): For design and development of the prototypes in line with 
improvements from proof-of-concept study. Sufficient development and trialling will ensure 
the systems work well and will be used and engaged with correctly. 
 
Prototype production – Primary manufacturer (£50,000) & heat panel manufacturer 
(£2,500) : An integral part of the study. The prototypes must be manufactured to a high 
standard to ensure they work reliably and are robust. 
 
Dissemination and conference fees (£2000): To attend applicable conferences such as 
Paediatric Rheumatology conference, European rheumatology conference, design4health, 
European health design conference. This will enable widespread dissemination of the 
findings (ensuring IP protection is maintained), increasing impact of the research project. 
 
13.0 Reporting and dissemination 
 
The findings from the proposed study will be compiled and reported to the Rheumatology 
team at Sheffield Children's Hospital. They will also be published in peer-reviewed papers 
and journals such as the Design4Health journal. 

 
 
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The findings will also be presented at national and international conferences including 
Paediatric Rheumatology conference, European rheumatology conference, design4health, 
European health design conference. This will enable widespread dissemination of the 
findings increasing impact of the research project. 
 
Results from the study will be used to inform further funding applications to progress the 
prototypes further in collaboration with Sheffield Children's Hospital. The study team 
includes members with specialist experience in medical technologies and senior clinicians in 
the field of JIA, ensuring appropriate experience and contacts for wide dissemination of 
results among the clinical and scientific communities 
 
14.0 Impact 
 
The proposed study aims to make a positive contribution to the field of JIA by improving the 
independence and functional ability of CYP with JIA through ‘JIA Toolbox’. CYP with JIA live 
with chronic or recurrent pain which severely impacts their day-to-day life, particularly in 
terms of daily physical tasks, relationships, school and social activities, as well as their 
emotional wellbeing and self-confidence. CYP with JIA often feel isolated and different, as 
shown in a 2012 study of children's experience of living with arthritis “the worst thing was 
that my disease was invisible”, often facing widespread lack of understanding from crucial 
stakeholders. Current products are difficult to use as most therapeutic aids are targeted 
towards an adult population. The few that are aimed at children come across as patronising 
and stigmatising, findings that were underlined in our previous work. 
 
‘JIA Toolbox’ is a multifaceted intervention that has received widespread initial praise from 
stakeholders as it specifically addresses their unmet needs. On an individual level, ‘JIA 
Toolbox’ has the potential to significantly improve CYP’s pain self-management skills, 
increase engagement with and adherence of physio regimes and improve communication 
with stakeholders. This would afford CYP with greater confidence and functional ability to 
participate across all spheres of their lives, across social, physical and educational domains, 
positively impacting their emotional wellbeing and wider life engagement.  
 
Within an educational context, ‘JIA Toolbox’ will help to increase awareness of the condition 
without stigmatising CYP. It will also provide them with a way to discreetly access necessary 
support, improving their concentration by removing anxiety around accessing help. 
 
Within a healthcare context, it will help to encourage self-management of the condition 
from a young age, promoting positive behaviour, which is particularly important during the 
post COVID-19 climate as well as during the transition process when CYP move to adult 
services. In addition, it is expected that ‘JIA Toolbox’ will improve compliance with 
recommended physiotherapy interventions which are often ignored despite the clinicians' 
recommendation. The socio-economic impact on wider healthcare organisations such as the 
NHS, is improved compliance with treatment as well as encouraging self-management. This 

 
 
JIA Toolbox Feasibility Study 
Protocol  
Version 2.0 
Date: 18.12.24 
IRAS ID: 336429 
 
14
can then help reduce the financial and time burden from repeated, potentially avoidable 
appointments, which ties in to the current organisations’ focus.  
 
A major priority for health services is helping people with long-term conditions (LTC’s), 
including arthritis, as highlighted in the 2030 Agenda for Sustainable Development. LTC’s 
such as JIA can be life-limiting with emotionally and physically debilitating effects. Longer 
term, JIA can restrict access to employment, putting increased pressure on the economy and 
healthcare resources. Developing self-management skills from a young age is crucial to 
managing chronic illness. Equipping children and young people to become confident in 
managing their own condition is particularly important as children and young people 
transition from children’s to adults’ services.  
 
Existing studies describing the experience of living with JIA tend to focus exclusively on one 
stakeholder’s experience or on the physical symptoms, neglecting both the wider life impact 
and insights of other stakeholders. This study will therefore provide contemporary data on 
children and young people's experiences of living with JIA to inform future research. As such, 
the expected outcomes of this research include deeper understanding around: 
1: contemporary data on the impact of JIA on the daily lives of children and young people 
with JIA and their parents/caregivers 
2: preliminary data assessing the potential impact of ‘JIA Toolbox’ in real-world settings 
 
15.0 Outcomes 
 
There are two overall outputs from this project:  
 
1. Output: Co-designed prototypes. The co-designed approach helps to ensure ‘JIA 
Toolbox’ will be useful, acceptable and of real benefit to the JIA community, 
improving chances of commercial success. 
 
2. Output: In depth data (symptom experience and prototype use patterns) from a 
larger cohort n=25 over a longer period (3 months). The feasibility study context 
enables early discovery of barriers to adoption and therefore can be addressed and 
rectified. It also helps builds up a strong evidence base on the effectiveness and 
viability of these devices, enabling a good standpoint from which to leverage further 
funding.