Monitoring of Inflammatory Conditions

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

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis; Psoriasis; Crohn Disease; Inflammatory Arthritis; Ulcerative Colitis; Psoriatic Arthritis; Reactive Arthritis; Inflammatory Disease; System; Lupus Erythematosus
• Intervention / Treatment: Other: Questionnaire; Other: Semi-structured interview

• Study Type: Observational
• Enrollment (Actual): 664

Contacts and Locations

• Study Contact: Name: Amy Fuller; Phone Number: 01158231761; Email: amy.fuller@nottingham.ac.uk
• Study Contact Backup: Name: Abhishek Abhishek; Email: abhishek.abhishek@nottingham.ac.uk

Study Locations

• United Kingdom
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
      • University of Nottingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Secondary care clinic and general population

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Questionnaire; A single questionnaire; Other: 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	Other: Semi-structured interview; A single semi-structured qualitative interview conducted face-to-face or by telephone or video-conference call.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To explore patient and HCP views and experiences of the current monitoring strategies.	This will be determined through interview	1 day
To measure patient adherence with current monitoring recommendations.	This will determined through patient questionnaire	1 day
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

Collaborators and Investigators

• Sponsor: University of Nottingham
• Investigators: Principal Investigator: Abhishek Abhishek, University of Nottingham

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2022
• Primary Completion (Actual): February 8, 2023
• Study Completion (Actual): February 8, 2023

Study Registration Dates

• First Submitted: July 11, 2022
• First Submitted That Met QC Criteria: July 11, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Skin Diseases; Infections; Immune System Diseases; Autoimmune Diseases; Disease Attributes; Gastrointestinal Diseases; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Gastroenteritis; Intestinal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Inflammatory Bowel Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Arthritis, Infectious; Chronic Disease; Post-Infectious Disorders; Arthritis; Lupus Erythematosus, Systemic; Psoriasis; Crohn Disease; Arthritis, Psoriatic; Arthritis, Reactive
• Other Study ID Numbers: 21042

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