Measuring how steroids affect children and young people with rheumatic conditions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.