Health Economic Impact of Steroids
ConditionRheumatic Conditions
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of the West of England
About this trial
Three focus groups will be conducted with patients who have an inflammatory rheumatic condition and have been treated with steroids in the last three years to discuss the impact of steroids on their quality of life, the financial costs to them and costs to the NHS and social care. We will also ask people to give their thoughts on a general patient reported outcome (PRO) questionnaire (the EQ5D) and a steroid-specific questionnaire (the Steroid PRO).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
People who have an inflammatory rheumatic condition.
People who are aged 18 years or older.
Have the capacity to give informed consent.
Have a good understanding of spoken and written English to be able to understand the participant information sheet, consent form and demographic form, and to participate in the focus group.
Disqualifiers
People who do not have an inflammatory rheumatic condition.
People who are less than 18 years of age.
Do not have the capacity to give informed consent.
Have insufficient understanding of spoken and written English be able to understand the participant information sheet, consent form and demographic form, and to participate in the focus group.
Trial population
Patients will be purposively sampled to include a spectrum of participants with a range of different inflammatory rheumatic conditions (including Rheumatoid Arthritis, Lupus, Giant Cell Arteritis) and demographics (including age, gender, ethnic group).
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
This is a qualitative focus group study therefore no interventions planned
Other interventionThis is a qualitative focus group study therefore no interventions planned
This is a qualitative focus group study therefore no interventions planned
BehavioralThis is a qualitative focus group study therefore no interventions planned
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: Patients with inflammatory rheumatic conditions.2 interventions
Trial outcomes
Primary outcomes
1
Steroid PRO
The Steroid PRO is a 15-item, valid and reliable scale for measuring the impact of glucocorticoid therapy in people with rheumatic diseases. The fifteen items are grouped into four domains (Social impact, Impact on Appearance, Psychological Impact and Treatment Concerns). The Steroid PRO responses options are presented across a 5-item Likert scale, with a numerical value attributed to the response: * Never (0) * Rarely (1) * Sometimes (2) * Often (3) * Always (4) Typically, each item or domain in the Steroid PRO is assigned a numerical value or score based on the response options provided. These scores may reflect the severity, frequency, or impact of symptoms, side effects, or other aspects of steroid therapy on the patient's well-being. The four subscales plus a total score can be used.
Time frame
Baseline (completed once during each focus group).2
EQ-5D-5L
The EQ-5D-5L is a short questionnaire used to understand how a person's health affects their quality of life. The questionnaire asks people to rate themselves across 5 areas of daily life: mobility (moving around), self-care (washing, dressing), usual activities (work, study, housework), pain or discomfort, and anxiety or depression. Each area has 5 levels (1 = no problems, 5 = extreme problems). A respondent selects one level for each area, producing a 5 digit code (e.g., 12345). There is also a Visual Analogue Scale where respondents rate their overall health today with 0 = worst imaginable health and 100 = best imaginable health.
Time frame
Baseline (completed once during each focus group).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of the West of England
Lead sponsor
UK Musculoskeletal Translational Research Collaboration (MSK TRC)
Collaborator
University of Leeds
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: