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Completed

NCT Number: NCT05458531

Monitoring of Inflammatory Conditions

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.

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Key information

Conditions

Inflammatory Disease Arthritis Arthritis, Infectious Arthritis, Psoriatic Arthritis, Reactive Arthritis, Rheumatoid Autoimmune Diseases Bone Diseases Chronic Disease Colitis Colitis, Ulcerative Colonic Diseases Connective Tissue Diseases Crohn Disease Digestive System Diseases Disease Attributes Gastroenteritis Gastrointestinal Diseases Immune System Diseases Infections Inflammatory Arthritis Inflammatory Bowel Diseases Intestinal Diseases Joint Diseases Lupus Erythematosus, Systemic Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Post-Infectious Disorders Psoriasis Psoriatic Arthritis Reactive Arthritis Rheumatic Diseases Rheumatoid Arthritis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis System; Lupus Erythematosus Ulcerative Colitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Nottingham

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Questionnaire

Other

A single questionnaire

semi-structured interview

Other

A single semi-structured qualitative interview conducted face-to-face or by telephone or video-conference call.

Primary outcomes

  1. To explore patient and HCP views and experiences of the current monitoring strategies.

    Time frame: 1 day

    This will be determined through interview

  2. To measure patient adherence with current monitoring recommendations.

    Time frame: 1 day

    This will determined through patient questionnaire

  3. To explore the acceptability of the new recommended monitoring strategy emerging from a prior modelling exercise, to patients and HCPs.

    Time frame: 1 day

    This will be determined through interview

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 14, 2022
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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