Cross-condition Validation of the Steroid PRO

University of the West of England

Status: Enrolling

Conditions: Immune System Disorder; Respiratory Disease; Gastrointestinal Diseases; Dermatologic Disease; Inflammatory Disease

Treatments: Other: Cognitive Interview

Study type: Observational

Funder types: Other

Identifiers

NCT06314451

HAS.22.11.035

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

Patients with respiratory, gastroenterology and dermatology inflammatory conditions

Description:

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.

Treatment:

Other: Cognitive Interview

Clinicians and researchers skilled in inflammatory diseases

Description:

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.

Treatment:

Other: Cognitive Interview