Testing a questionnaire about steroid treatment effects on quality of life
Cross-condition Validation of the Patient Reported Outcome Measure for Patients Receiving Glucocorticoids (the Steroid PRO)
This study is testing a new questionnaire to see how steroid treatment affects the quality of life for adults with inflammatory and autoimmune conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of the West of England Academic / other |
| Locations | 1 site (Bristol) |
| Trial ID | NCT06314451 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate a questionnaire designed to assess the impact of glucocorticoid treatment on the quality of life of patients with various inflammatory and autoimmune conditions. Participants aged 18 and over, who are currently taking steroids for conditions affecting the skin, lungs, or gastrointestinal tract, will be interviewed to provide feedback on the questionnaire's relevance and clarity. The study involves a single interview conducted online or by telephone, where participants will discuss their experiences and the questionnaire's content. The research is funded by Sanofi and conducted by independent researchers at the University of the West of England.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over diagnosed with autoimmune or inflammatory conditions who have been treated with glucocorticoids within the past year.
Not a fit: Patients under 18 or those not diagnosed with relevant autoimmune or inflammatory conditions will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of how steroid treatments affect patients' daily lives, leading to improved patient care and management.
How similar studies have performed: Previous studies have successfully utilized patient-reported outcomes to assess treatment impacts, suggesting this approach is promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged ≥ 18 years old * Diagnosed with an autoimmune or inflammatory respiratory, gastroenterology or dermatology condition * Treatment with glucocorticoids with intravenous or oral glucocorticoids for an autoimmune or inflammatory condition within the previous year (or longer duration). * Ability to give consent. Exclusion Criteria: * Aged \<18 years old * No autoimmune or inflammatory respiratory, gastroenterology or dermatology diagnosis * Not treated with glucocorticoids with intravenous or oral glucocorticoids for an autoimmune or inflammatory condition within the previous year (or longer duration) * Unable to give consent
Where this trial is running
Bristol
- University of the West of England — Bristol, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Joanna C Robson, FRCP PhD — University of the West of England
- Study coordinator: Joanna C Robson, FRCP PhD
- Email: jo.robson@uwe.ac.uk
- Phone: 0117 3427418
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.