Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
664 participants
OBSERVATIONAL
2022-06-28
2023-02-08
Brief Summary
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This study aims to measure how often patients' with common inflammatory conditions on long-term immune suppressing medication attend their monitoring blood tests as currently recommended, and uncover patients' and HCP views and experiences of the current blood-test monitoring strategy, and the acceptability of potential changes to this in the future.
Firstly, patients with an inflammatory condition on long-term immune suppressing treatment will be invited to complete a questionnaire which will ask about their demographic information, medical condition(s), immune-suppressing treatment, adherence to the monitoring blood tests and willingness to take part in an interview. Then, both patients and HCPs who care for such patients will be invited to take part in a single, semi-structured interview. Interviews will be face-to-face, by telephone or video-call, last up to one hour and digitally audio-recorded. Patient interviews will explore their perceptions of risk, benefits and experiences of current testing, and views on the new testing frequencies emerging from the study prior. HCP interviews will explore their perceptions of current testing including, the practicalities, usefulness, risks and benefits of the blood tests, and views on the new testing frequencies emerging from the study prior.
The findings will shape the recommendations for a new monitoring strategy, ensuring it is acceptable to patients and HCPs.
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Detailed Description
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Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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Patients with an inflammatory disease taking immune-suppressing medication
Aged 18 years and over, able to give consent, diagnosed with one of the above inflammatory conditions and currently treated with one of the following immune-suppressing treatments for six months or longer: methotrexate, azathioprine, 5-acetyl salicylates, sulfasalazine, mycophenolate mofetil, leflunomide or biologics.
Questionnaire
A single questionnaire
Semi-structured interview
A single semi-structured qualitative interview conducted face-to-face or by telephone or video-conference call.
Healthcare professionals
Consultants, general practitioners (GPs), nurse specialists, practice nurses and pharmacists with experience of prescribing and monitoring long-term immune-suppressing treatments for the above inflammatory diseases
Semi-structured interview
A single semi-structured qualitative interview conducted face-to-face or by telephone or video-conference call.
Interventions
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Questionnaire
A single questionnaire
Semi-structured interview
A single semi-structured qualitative interview conducted face-to-face or by telephone or video-conference call.
Eligibility Criteria
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Inclusion Criteria
* Ability to give informed consent
* Diagnosis with one of the following inflammatory diseases: rheumatoid arthritis, inflammatory arthritis, inflammatory bowel disease, psoriasis +/- arthritis, ankylosing spondylitis, systemic lupus erythematosus, or reactive arthritis, and
* Currently treated with one of the following immune suppressing treatments for six months or longer: methotrexate, azathioprine, 5-acetyl salicylates, sulfasalazine, mycophenolate mofetil, leflunomide or biologics (anti-TNF-α agents e.g. etanercept, adalimumab, infliximab, golimumab, or certolizumab or their biosimilar).
Exclusion Criteria
* Chronic liver disease: Autoimmune hepatitis, hepatitis B or C, cirrhosis.
* Pre-existing haematological abnormalities: Myelodysplasia, primary haematological diseases with neutropenia or thrombocytopenia.
* Dementia.
18 Years
ALL
Yes
Sponsors
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University of Nottingham
OTHER
Responsible Party
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Principal Investigators
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Abhishek Abhishek
Role: PRINCIPAL_INVESTIGATOR
University of Nottingham
Locations
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University of Nottingham
Nottingham, Nottinghamshire, United Kingdom
Countries
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Other Identifiers
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21042
Identifier Type: -
Identifier Source: org_study_id
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