Clinical trial NCT05458531: Monitoring of Inflammatory Conditions
Official title: Exploring Patient and Healthcare Professional Views and Experiences of the Current and Recommended Monitoring Strategies for Inflammatory Conditions Treated With Commonly Used Immune Suppressing Drugs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Disease
Crohn Disease
Ulcerative Colitis
Rheumatoid Arthritis
System; Lupus Erythematosus
Psoriatic Arthritis
Reactive Arthritis
Inflammatory Arthritis
Psoriasis
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2022-07-14
Enrollment: 664
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Secondary care clinic and general population

Brief summary: People with inflammatory diseases treated with immune-suppressing medication are recommended to have regular blood-tests to monitor for potential side-effects of this treatment on their blood count, liver and kidneys. However, it is not clear that monitoring is needed as frequently as currently recommended in the long-term, with side-effects being rare after one year of treatment. A study is currently underway to determine the optimal blood-test monitoring strategy which is cost-effective but still safe. Any changes in the monitoring strategy must be acceptable to patients and the healthcare professionals (HCP) that treat them.

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.


Eligibility criteria: Inclusion Criteria:

* Age 18 years and over
* 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 kidney disease: stage 4 or stage 5
* Chronic liver disease: Autoimmune hepatitis, hepatitis B or C, cirrhosis.
* Pre-existing haematological abnormalities: Myelodysplasia, primary haematological diseases with neutropenia or thrombocytopenia.
* Dementia.

Primary outcomes:
measure: To explore patient and HCP views and experiences of the current monitoring strategies.
timeFrame: 1 day
measure: To measure patient adherence with current monitoring recommendations.
timeFrame: 1 day
measure: To explore the acceptability of the new recommended monitoring strategy emerging from a prior modelling exercise, to patients and HCPs.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: University of Nottingham
state: Nottinghamshire
Study officials:
affiliation: University of Nottingham
name: Abhishek Abhishek
role: PRINCIPAL_INVESTIGATOR
References: