An observational study in Rheumatic Diseases, Rheumatic Disorder and Rheumatologic Conditions (JRA,Lupus), sponsored by University of the West of England. Recruiting at 3 sites in United Kingdom. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-01-20.
Sponsored by University of the West of England · Observational
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.
264 studies on the registry are indexed under Rheumatic Diseases; 60 are open to participants now.
This study's planned enrollment of 70 is below the median of 225 across 90 observational studies indexed under Rheumatic Diseases.
Browse Rheumatic Diseases studies →University of the West of England is the lead sponsor of 26 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Three NHS sites (paediatric rheumatology clinics) will be used for recruitment of participants:
Bristol Royal Hospital for Children Alder Hey Children's Hospital (Liverpool) Royal Hospital for Children (Glasgow)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1. Rheumatology patients aged 0 to18 years old. 2. Patients should have capacity to assent or consent immediately prior to the interview.
3. The patient should have a good understanding of spoken and written English be able to understand the participant information sheets, assent/consent forms.
4. Treatment with with intravenous or oral glucocorticoids for an or inflammatory condition within the previous two years (or longer duration).
Parents/guardians:
Exclusion Criteria:
1. Rheumatology patients who are more than 18 years of age. 2. Patients who do not have capacity to assent or consent immediately prior to the interview.
3. Patient who have insufficient understanding of spoken and written English be able to understand the participant information sheets, assent/consent forms.
4. Patients who either have never taken or have not taken steroids within the last two years as part of their treatment plan for their rheumatological condition.
5. Relative is not a parent or legal guardian. 6. Parents/guardians of rheumatology patients fulfilling any of the exclusion criteria above.
7. Parents/guardians who do not have capacity to assent or consent immediately prior to the interview.
8. Parents/guardians who have insufficient understanding of spoken and written English be able to understand the participant information sheets, assent/consent forms.
9. Parents/guardians of rheumatology patients who have never taken steroids or have not taken steroids within the last two years as part of their treatment plan for their rheumatological condition.
10. Membership of the steering committee
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
To explore the impact of glucocorticoids (steroids) on health-related quality of life (HRQoL) in CYP.
To develop a long list of potential questionnaire items for one or more patient reported outcome measures (PRO) for children and young people, who are treated with glucocorticoids, which assesses its impact of this treatment on their symptoms and everyday life.
Time frame: Through study completion, an average of 1 year.
Secondary analysis of specific topics of greatest importance to patients and families may be performed based on anonymised qualitative dataset from objective 1
Secondary analyses may in future also be used to explore specific topics of importance within the qualitative data, depending on what emerges as of greatest importance (e.g. impact on appearance, sense of self).
Time frame: Through study completion, an average of 1 year.
Plan to share: Undecided — This is not a trial, it is an exploratory qualitative study, therefore outcome measures are not relevant.
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Oct 2026, 11 months after the start.
Of 36 observational studies under Rheumatic Diseases, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 14. This study's planned 11 months is below that.
How these figures are worked out, and which studies are left out of them.
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University of the West of England