Monitoring of Inflammatory Conditions

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05458531
• Other study ID #: 21042
• Status: Completed
• Start date: June 28, 2022
• Est. completion date: February 8, 2023

Study information

• Verified date: February 2024
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 664
• Est. completion date: February 8, 2023
• Est. primary completion date: February 8, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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-a 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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Arthritis, Reactive
• Crohn Disease
• Inflammatory Arthritis
• Inflammatory Disease
• Lupus Erythematosus, Systemic
• Psoriasis
• Psoriatic Arthritis
• Reactive Arthritis
• Rheumatoid Arthritis
• System; Lupus Erythematosus
• Ulcerative Colitis

Intervention

Other:
• Questionnaire
A single questionnaire
• Semi-structured interview
A single semi-structured qualitative interview conducted face-to-face or by telephone or video-conference call.

Locations

Country	Name	City	State
United Kingdom	University of Nottingham	Nottingham	Nottinghamshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To explore patient and HCP views and experiences of the current monitoring strategies.	This will be determined through interview	1 day
Primary	To measure patient adherence with current monitoring recommendations.	This will determined through patient questionnaire	1 day
Primary	To explore the acceptability of the new recommended monitoring strategy emerging from a prior modelling exercise, to patients and HCPs.	This will be determined through interview	1 day