Monitoring of Inflammatory Conditions

NCT05458531 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 664

Last updated 2024-02-28

No results posted yet for this study

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

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

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05458531 on ClinicalTrials.gov