Monitoring of Inflammatory Conditions

NCT05458531 | Completed

• 1 other identifier: 21042
• Study Type: observational
• Target: 664
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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; Other: Semi-structured interview

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

Interventions

Questionnaire OTHER

A single questionnaire

Patients with an inflammatory disease taking immune-suppressing medication

Semi-structured interview OTHER

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

Healthcare professionals; Patients with an inflammatory disease taking immune-suppressing medication

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Secondary care clinic and general population

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

University of Nottingham

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Location

MeSH Terms

Conditions

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

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Abhishek Abhishek

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 14, 2022
• Study Start: June 28, 2022
• Primary Completion: February 8, 2023
• Study Completion: February 8, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)