Respiratory Disease Clinical Trial
Official title:
Cross-condition Validation of the Patient Reported Outcome Measure for Patients Receiving Glucocorticoids (the Steroid PRO)
NCT number | NCT06314451 |
Other study ID # | HAS.22.11.035 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2022 |
Est. completion date | May 31, 2024 |
Testing a questionnaire about treatment with steroids for skin, lung or gastric conditions
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of the West of England | Bristol |
Lead Sponsor | Collaborator |
---|---|
University of the West of England | Johns Hopkins University, University of Pittsburgh |
United Kingdom,
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
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 |
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