Exploring and Measuring the Impact of Steroids in Children and Young People
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 18
SponsorUniversity of the West of England
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Rheumatology patients aged 0 to18 years old. 2. Patients should have capacity to assent or consent immediately prior to the interview.
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.
Disqualifiers
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.
Trial population
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)
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
70 Participants
are grouped into 8 trial groups8
Trial groupsSee each trial group below.
Group A: Focus groups for parents with children under 8 years old
Group B: Focus groups with children 8-12 years old
Group C: Focus groups for young people aged 13-15 years old
Group D: Focus groups for young people aged 16-18 years old
Group E: Cognitive interviewing for parents with children under 8 years old
Group F: Cognitive interviewing for children 8-12 years old
Group G: Cognitive interviewing for young people aged 16-18 years old
Group H: Cognitive interviewing for young people aged 13-15 years old
Trial outcomes
Primary outcomes
1
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 outcomes
1
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of the West of England
Lead sponsor
Alder Hey Children's NHS Foundation Trust
Collaborator
Bristol Royal Hospital for Children
Collaborator
Royal Hospital for Sick Children
Collaborator
Source ClinicalTrials.gov