Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05563194
Other study ID # SCH-2628
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 15, 2022
Est. completion date March 31, 2023

Study information

Verified date June 2023
Source Sheffield Children's NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date March 31, 2023
Est. primary completion date February 15, 2023
Accepts healthy volunteers No
Gender All
Age group 7 Years to 16 Years
Eligibility 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

Study Design


Intervention

Device:
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.
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.
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.

Locations

Country Name City State
United Kingdom Sheffield Children's NHS Foundation Trust Sheffield

Sponsors (1)

Lead Sponsor Collaborator
Sheffield Children's NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT05719389 - EFFICACY AND SAFETY OF S.C. INFLIXIMAB IN PATIENTS SWITCHED FROM I.V. FORMULATION OF INFLIXIMAB
Active, not recruiting NCT05846672 - Turkish Cultural Adaptation, Validity and Reliability of the "Gait Outcomes Assessment List"
Recruiting NCT06339957 - Rheumatology Diet Study
Not yet recruiting NCT06461000 - EULAR Impact of Rheumatic and Musculoskeletal Diseases Survey
Recruiting NCT05621369 - Psorcast Mobile Study
Completed NCT02530996 - Systemic Sclerosis (SSc) Vasculopathy: Improved Clinical Monitoring and Treatment Phase 1/Phase 2
Recruiting NCT06227468 - A Clinical Study to Map the HLA Genomic Region in the Greek Population
Completed NCT05015114 - Prevalence and Factors of Sarcopenia and in Patients With Primary Sjogren's Syndrome