Cross-condition Validation of the Steroid PRO

Respiratory Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06314451
• Other study ID #: HAS.22.11.035
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: May 31, 2024

Study information

• Verified date: March 2024
• Source: University of the West of England
• Contact: Joanna C Robson, FRCP PhD
• Phone: 0117 3427418
• Email: jo.robson[@]uwe.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dermatologic Disease
• Digestive System Diseases
• Gastrointestinal Diseases
• Immune System Diseases
• Immune System Disorder
• Inflammatory Disease
• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases
• Skin Diseases

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	University of the West of England	Bristol

Sponsors (3)

Lead Sponsor	Collaborator
University of the West of England	Johns Hopkins University, University of Pittsburgh

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Bridgewater S, Ndosi M, Dawson J, Richards P, Silverthorne C, Dures E, Goodman SM, Hill C, Mackie SL, Robson JC. Validation of a new glucocorticoid-specific Patient-Reported Outcome Questionnaire (the Steroid PRO). Ann Rheum Dis. 2024 Feb 15;83(3):394-400. doi: 10.1136/ard-2023-224946. — View Citation

Bridgewater S, Shepherd MA, Dawson J, Richards P, Silverthorne C, Ndosi M, Almeida C, Black RJ, Cheah JTL, Dures E, Ghosh N, Hoon EA, Lyne S, Navarro-Millan I, Pearce-Fisher D, Ruediger C, Tieu J, Yip K, Mackie SL, Goodman S, Hill C, Robson JC. Measuring the impact of steroid therapy on health-related quality of life in patients with rheumatic diseases: international development of a glucocorticoid treatment-specific patient-reported outcome measure. Rheumatology (Oxford). 2023 Nov 2;62(11):3565-3575. doi: 10.1093/rheumatology/kead081. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	November 2022 - May 2024