Exploring and Measuring the Impact of Steroids in Children and Young People
Recruiting · NCT07350395 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of the West of England
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Inclusion criteria
- 1\. Rheumatology patients aged 0 to18 years old. 2. Patients should have capacity to assent or consent immediately prior to the interview.
- \. The patient should have a good understanding of spoken and written English be able to understand the participant information sheets, assent/consent forms.
- \. Treatment with glucocorticoids with intravenous or oral glucocorticoids for an autoimmune or inflammatory condition within the previous two years (or longer duration).
- Parents/guardians:
- Parents (mother/ father) or legal guardians of rheumatological patients fulfilling criteria 1-4 above.
- Parents or legal guardians should have capacity to consent for themselves (+/- their child) immediately prior to the interview.
- 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.
- \. Patient who have insufficient understanding of spoken and written English be able to understand the participant information sheets, assent/consent forms.
- \. 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.
- \. Relative is not a parent or legal guardian. 6. Parents/guardians of rheumatology patients fulfilling any of the exclusion criteria above.
- \. Parents/guardians who do not have capacity to assent or consent immediately prior to the interview.
- \. Parents/guardians who have insufficient understanding of spoken and written English be able to understand the participant information sheets, assent/consent forms.
- \. 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.
- \. Membership of the steering committee
Where it is running
3 locations listed.
- Bristol Royal Hospital for Children - Bristol, North Somerset, United Kingdom
- Royal Hospital for children Glasgow - Glasgow, North Somerset, United Kingdom
- Alder Hey Hospital - Liverpool, North Somerset, United Kingdom