Measuring how steroids affect children and young people with rheumatic conditions
Assessing the Impact of Glucocorticoids in Children and Young People With Rheumatic Conditions, to Develop a Patient Reported Outcome Measure (PROM).
This project will create a questionnaire, using interviews with children, young people and their parents, to measure how steroids affect kids with rheumatic conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | University of the West of England Academic / other |
| Locations | 3 sites (Bristol, North Somerset and 2 other locations) |
| Trial ID | NCT07350395 on ClinicalTrials.gov |
What this trial studies
Investigators will conduct qualitative interviews with children and young people (and their parents/guardians) who have received oral or intravenous glucocorticoids for rheumatic conditions, aiming to capture steroid-related symptoms and impacts on health-related quality of life. Interview findings will be used to generate questionnaire items, followed by cognitive testing and pilot refinement of a patient-reported outcome measure (PROM). Recruitment is limited to eligible participants able to consent/assent and understand English, drawn from pediatric rheumatology services at participating UK centers. The resulting PROM is intended for use in clinical care and research to quantify the effects of steroid treatment in this population.
Who should consider this trial
Good fit: Ideal candidates are rheumatology patients aged 0–18 who have received oral or IV glucocorticoids for an autoimmune or inflammatory condition within the past two years (and their parents/guardians), and who can consent/assent and understand English.
Not a fit: Patients who have never taken glucocorticoids, cannot communicate in English, or lack capacity to consent/assent are unlikely to benefit from participating in this PROM development work.
Why it matters
Potential benefit: If successful, the PROM could give clinicians and researchers a reliable way to measure how steroids affect quality of life for children and young people and help guide treatment choices.
How similar studies have performed: Developing PROMs through patient and parent interviews is a well-established method in pediatric research, but a steroid-specific PROM for children with rheumatic disease appears to be a novel, unmet need.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 glucocorticoids with intravenous or oral glucocorticoids for an autoimmune or inflammatory condition within the previous two years (or longer duration). Parents/guardians: 1. Parents (mother/ father) or legal guardians of rheumatological patients fulfilling criteria 1-4 above. 2. Parents or legal guardians should have capacity to consent for themselves (+/- their child) immediately prior to the interview. 3. The parents or legal guardians should have a good understanding of spoken and written English be able to understand the participant information sheets, assent/consent forms. 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 steroids 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
Where this trial is running
Bristol, North Somerset and 2 other locations
- Bristol Royal Hospital for Children — Bristol, North Somerset, United Kingdom (Recruiting)
- Royal Hospital for children Glasgow — Glasgow, North Somerset, United Kingdom (Recruiting)
- Alder Hey Hospital — Liverpool, North Somerset, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Emily Barnes
- Email: emily4.barnes@live.uwe.ac.uk
- Phone: +447747560680
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.