An observational study in Inflammatory Disease, Immune System Disorder and Gastrointestinal Diseases, sponsored by University of the West of England. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-20.
Sponsored by University of the West of England · Observational
Testing a questionnaire about treatment with steroids for skin, lung or gastric conditions
Glucocorticoid drugs, also known as 'steroids', are used to treat a range of diseases. It is well-known that steroids can cause many unwanted side-effects. The investigators are interested in measuring the impact of steroids on quality of life, from the patients' perspective.
In a previous part of this study, the investigators interviewed participants treated with steroids for a range of rheumatic conditions. The participants were asked how taking steroids affects their everyday lives. A patient questionnaire (the 'Steroid PRO') was then created focused on the topics identified as being most important to participants.
Now the investigators would like to test this questionnaire with new participants, aged 18 or over, who are taking steroids for other conditions. This could include participants who have inflammation in the lungs, skin, or bowels. The investigators will also ask for feedback from the medical teams who care for those who have these conditions.
The study involves a single interview with a researcher, either online or by telephone. Participants who want to take part will be given information about the study and asked to give written consent. Participants will be asked to talk about the wording of the questionnaire and how relevant and feasible it is to them.
This part of the study is funded by Sanofi Research and Development. The work is being carried out by independent researchers at the University of the West of England (UWE, Bristol). Participants will be recruited from hospitals in the UK and USA.
The investigators hope that the Steroid PRO questionnaire will be used in future research trials about steroid treatment and alternatives to steroids. The Steroid PRO questionnaire could also be used in clinics to improve communication between clinicians and patients.
427 studies on the registry are indexed under Immune System Diseases; 86 are open to participants now.
This study's planned enrollment of 60 is below the median of 246 across 88 observational studies indexed under Immune System Diseases.
Browse Immune System 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.
For each of the medical specialties (respiratory, gastroenterology, dermatology), 20 patients will be purposively sampled to include a spectrum of participants with a range of different diseases and demographics (age, gender, country) for each indication.
Key conditions will include inflammatory bowel disease (Ulcerative Colitis, Crohn's disease, Eosinophilic gastroenteritis), dermatological conditions (e.g subacute cutaneous lupus erythematosus (SCLE) systemic vasculitis, pemphigus, pemphigoid, atopic dermatitis), and respiratory conditions (asthma, COPD and interstitial lung disease).
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.
Exclusion Criteria:
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.
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.
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.
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.
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.
Patients will be purposively sampled to include a spectrum of participants with a range of different diseases and demographics (age, gender, country) for each indication. Sample size will also be led by the point at which no further issues are emerging during the cognitive interview process.
Other: Cognitive Interview
Clinician researchers from each country (UK, USA) will be purposively sampled to include a spectrum of participants with a range of clinical experience and demographics (age, gender, country). Sample size will also be led by the point at which no further issues are emerging during the cognitive interview process.
Other: Cognitive Interview
The study involves a single cognitive interview with a researcher, either online, by telephone, or face-to-face. People who want to take part will be given information about the study and asked to give written consent. Then they will be asked to talk about the wording of the questionnaire and how relevant it is to them. Cognitive interviewing is recognized as a significant part of developing questionnaires for patient reported outcome measures (PROMs). The cognitive interviewing process used in PROM development will be adapted in this study to test the Steroid PRO in new disease populations. Cognitive interviewing will be carried out using pragmatic, light-touch interviews, underpinned by think aloud techniques and clean language principles.
Steroid PRO
Validated outcome measure to capture the impact of treatment with glucocorticoids on health related quality of life (Bridgewater ARD 2023). 15 item questionnaire, 4 domains (Impact on Appearance, Psychological Impact, Social impact and Treatment Concerns). Steroid PRO is the full title of the outcome measure. A PRO is a patient reported outcome. Higher scores equal greater impact on health related quality of life. Raw scores: minimum possible score 0, maximum 45.
Time frame: November 2022 - May 2024
Plan to share: No
Started Jun 2022 (actual). Primary completion is estimated for May 2024, 23 months after the start.
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University of the West of England