Cross-condition Validation of the Steroid PRO

Recruiting

• Conditions: Dermatologic Disease; Inflammatory Disease; Gastrointestinal Diseases; Respiratory Disease; Immune System Disorder
• Interventions: Other: Cognitive Interview

• Registration Number: NCT06314451
• Lead Sponsor: University of the West of England

Brief Summary

Testing a questionnaire about treatment with steroids for skin, lung or gastric conditions

Detailed Description

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.

Study Timeline

• Study Start: 2022-06-01
• Study First Submitted: 2023-03-16
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-13
• Study First Posted: 2024-03-18
• Last Update Submitted: 2024-03-18
• Last Update Posted: 2024-03-20
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with respiratory, gastroenterology and dermatology inflammatory conditions	Cognitive Interview	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.
Clinicians and researchers skilled in inflammatory diseases	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.

Primary Outcome Measures

Name	Time	Method
Steroid PRO	November 2022 - May 2024	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.

Trial Locations

Locations (1)

University of the West of England; 🇬🇧 Bristol, United Kingdom