Trials / Completed
CompletedNCT05458531
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 664 (actual)
- Sponsor
- University of Nottingham · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2022-06-28
- Primary completion
- 2023-02-08
- Completion
- 2023-02-08
- First posted
- 2022-07-14
- Last updated
- 2024-02-28
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT05458531. Inclusion in this directory is not an endorsement.