Monitoring of Inflammatory Conditions
NCT05458531 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 664
Last updated 2024-02-28
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
Interventions
- 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.
Sponsors & Collaborators
-
University of Nottingham
lead OTHER
Principal Investigators
-
Abhishek Abhishek · University of Nottingham
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-06-28
- Primary Completion
- 2023-02-08
- Completion
- 2023-02-08
Countries
- United Kingdom
Study Locations
More Related Trials
-
Evaluation of Serum Galectin-9 Level in Systemic Lupus Erythematosus Patients and it's Association With Disease Activity and Organ Damage
NCT04558814 ·Status: UNKNOWN ·Phase: NA
-
Immune Mediators and Metabolites to Stratify Systemic Lupus Erythematosus Patients at High Risk of Cardio Vascular Diseases
NCT04276701 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
The Relationship Between COVID-19 and Autoimmune Diseases, Lessons From Practice
NCT04558203 ·Status: COMPLETED
-
Biomarkers of Lupus Disease: Serial Biomarker Sampling in Patients With Active Systemic Lupus Erythematosus (SLE)
NCT00987831 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Regulatory BCells in Systemic Lupus Erythematosus
NCT03178721 ·Status: UNKNOWN
-
Exploring Biomarkers for Therapeutic Response of Lupus Nephritis Based on Multi Omics Analysis
NCT06167174 ·Status: RECRUITING
-
A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Nephritis
NCT01085097 ·Status: COMPLETED ·Phase: PHASE2
-
Induction Treatment of Proliferative Lupus Nephritis With Leflunomide Combined With Prednisone
NCT00268567 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Effect of Injectable Anticoagulants on Research for a Circulating Lupus-type Anticoagulant
NCT05416190 ·Status: COMPLETED ·Phase: NA
-
Premature Atherosclerosis in Systemic Lupus Erythematosus
NCT04037293 ·Status: UNKNOWN
-
Assessment of Anxiety, Depression, Sleep Quality and Quality of Life in Systemic Lupus Erythematosus Patients
NCT05971498 ·Status: UNKNOWN
-
Lymphocyte Sub-populations and Auto Immune Diseases
NCT03901664 ·Status: COMPLETED
-
Immunome Project Consortium for Autoinflammatory Disorders
NCT03919110 ·Status: COMPLETED
-
The Effect of Mycophenolate Mofetil and Cyclophosphamide on the Lymphocyte Subsets in Patients With Proliferative Lupus Nephritis
NCT02954939 ·Status: RECRUITING ·Phase: NA
-
A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus
NCT02391259 ·Status: COMPLETED ·Phase: PHASE1
-
Screening Biomarkers for Severe Lupus Based on Multi-omics Studies
NCT05539001 ·Status: UNKNOWN
-
Haematological Indices in Systemic Lupus Erythematosus
NCT04110184 ·Status: UNKNOWN
-
PRediction Of Flares In Lupus With autoantibodiEs and Chemokines
NCT04951427 ·Status: UNKNOWN
-
Leflunomide Versus Azathioprine for Maintenance Therapy of Lupus Nephritis
NCT01172002 ·Status: UNKNOWN ·Phase: NA
-
Observational Study Investigating Demographic and Clinical Characteristics of SLE Patients in Egypt
NCT07144514 ·Status: NOT_YET_RECRUITING
-
Autoantibodies Prevalence During Checkpoint Inhibitor Treatment
NCT04220034 ·Status: COMPLETED
-
Identifying New Therapeutic Targets for Lupus Treatment
NCT03921398 ·Status: COMPLETED
-
Disease Activity Biomarkers in Patients With Systemic Lupus Erythematosus
NCT05443516 ·Status: RECRUITING
-
The Efficacy and Safety of ITF2357 in AIS
NCT00442182 ·Status: UNKNOWN ·Phase: PHASE2
-
Serologic Profile of SARS CoV2 in COVID-19 Patients With Systemic Diseases
NCT04530461 ·Status: UNKNOWN