JIA (Juvenile Idiopathic Arthritis) Toolbox Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in self-management of JIA Questionnaire
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Children and young people with a diagnosis of Juvenile Idiopathic arthritis
Single arm study where all participants will receive the three prototype interventions.
干预措施: Heating prototype (Prototype 1) (Device)
Children and young people with a diagnosis of Juvenile Idiopathic arthritis
Single arm study where all participants will receive the three prototype interventions.
干预措施: Physio tool (Prototype 2) (Device)
Children and young people with a diagnosis of Juvenile Idiopathic arthritis
Single arm study where all participants will receive the three prototype interventions.
干预措施: Communication tool (Prototype 3) (Device)
结局指标
主要结局
Change in self-management of JIA Questionnaire
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点