NCT06314451

Cross-condition Validation of the Steroid PRO

Cross-condition Validation of the Patient Reported Outcome Measure for Patients Receiving Glucocorticoids (the Steroid PRO)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: University of the West of England · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Inflammatory Disease
• Immune System Disorder
• Gastrointestinal Diseases
• Dermatologic Disease
• Respiratory Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-06-01
• Primary completion: 2024-05-31
• Completion: 2024-05-31
• First posted: 2024-03-18
• Last updated: 2024-03-20

Locations

1 site across 1 country: United Kingdom