Cross-condition Validation of the Steroid PRO

March 18, 2024 updated by: University of the West of England

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Bristol, United Kingdom, BS2 8HW
        • Recruiting
        • University of the West of England
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

For each of the medical specialties (respiratory, gastroenterology, dermatology), 20 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.

Key conditions will include inflammatory bowel disease (Ulcerative Colitis, Crohn's disease, Eosinophilic gastroenteritis), dermatological conditions (e.g subacute cutaneous lupus erythematosus (SCLE) systemic vasculitis, pemphigus, pemphigoid, atopic dermatitis), and respiratory conditions (asthma, COPD and interstitial lung disease).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with respiratory, gastroenterology and dermatology inflammatory conditions
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.
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.
Clinicians and researchers skilled in inflammatory diseases
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Steroid PRO
Time Frame: 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.
November 2022 - May 2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of the West of England

Collaborators

Johns Hopkins University
University of Pittsburgh

Investigators

  • Principal Investigator: Joanna C Robson, FRCP PhD, University of the West of England

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

May 31, 2024

Study Registration Dates

First Submitted

March 16, 2023

First Submitted That Met QC Criteria

March 13, 2024

First Posted (Actual)

March 18, 2024

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAS.22.11.035

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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