At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Not specified by the sponsor
- How long the study runs
- Study runs about 13 months (dates as stated)
- About the drug or intervention
- Not specified by the sponsor
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- Up to 18 Years
- Who
- All
- Number of participants
- 70
- Started
- 2025-11-01
- Last checked
- 2026-01
Plain English Summary
What is this study?
- • Testing a new treatment for rheumatic diseases
- • Clinical study - 70 participants
- • Assessing the impact of glucocorticoids in children and young people with rheumatic conditions, to develop a patient reported outcome measure (PROM)
Who can take part?
- • Ages Up to 18 Years
- • Diagnosed with rheumatic diseases
Where?
- • Bristol - Bristol Royal Hospital for Children
- • Glasgow - Royal Hospital for children Glasgow
- • Liverpool - Alder Hey Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Assessing the impact of glucocorticoids in children and young people with rheumatic conditions, to develop a patient reported outcome measure (PROM). Glucocorticoids, also known as steroids, are a very effective medication for the treatment of rheumatological conditions. They are used to reduce inflammation, pain and damage to organs. However, steroids can have some unwanted side effects, such as, increased weight, skin changes, feeling anxious, delayed puberty, diabetes and loss of bone mass. These side effects can therefore impact children and young people's health related quality of life (HRQoL). The investigators would like to create a new questionnaire for children and young people (CYP) who take steroids due to their rheumatological condition. The questionnaire, called a Patient Reported Outcome Measure, (PROM), will measure how steroids are affecting CYP. The first step in creating the questionnaire is to talk to children, young people and their parents/guardians about their experiences of taking steroids. The investigators plan to do this in focus groups, with people around the same age. The second step will then be to take everything people said in the focus group to create the questions in the questionnaire. Cognitive interviewing will then be used in a structured one on one interview to test for relevance, clarity and understanding of the questions. Children, young people and their parents/guardians will be involved throughout the research. Children and young people will give their thoughts and feedback on resources created for participants (consent forms/assent forms/participation information sheet/interview schedule), as well as how the focus groups and cognitive interviews should be structured. With consent, participants will be provided with a lay summary of the results. Results will also be published within peer-reviewed journals, special interest groups, trial meetings, patient charity meetings and presented at conferences.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: Up to 18 Years
- Who can join: All genders
What the study is looking for
- ✓1\. Rheumatology patients aged 0 to18 years old. 2. Patients should have capacity to assent or consent immediately...
- ✓3\. The patient should have a good understanding of spoken and written English be able to understand the participant...
- ✓4\. Treatment with glucocorticoids with intravenous or oral glucocorticoids for an autoimmune or inflammatory...
- ✓Parents/guardians:
- ✓Parents (mother/ father) or legal guardians of rheumatological patients fulfilling criteria 1-4 above.
Who cannot take part
- ✗1\. Rheumatology patients who are more than 18 years of age. 2. Patients who do not have capacity to assent or...
- ✗3\. Patient who have insufficient understanding of spoken and written English be able to understand the participant...
- ✗4\. Patients who either have never taken steroids or have not taken steroids within the last two years as part of...
- ✗5\. Relative is not a parent or legal guardian. 6. Parents/guardians of rheumatology patients fulfilling any of the...
- ✗7\. Parents/guardians who do not have capacity to assent or consent immediately prior to the interview.
See the full criteria
Where Is This Study? (3 UK sites)
Bristol Royal Hospital for Children
Bristol BS2 8BJ, United Kingdom
Royal Hospital for children Glasgow
Glasgow G51 4TF, United Kingdom
Alder Hey Hospital
Liverpool L12 2AP, United Kingdom
How to Get in Touch
Emily Barnes
Sponsor contactCONTACT
Dr Jo Robson
Sponsor contactCONTACT