OPINION: Vaccination Perception in Inflammatory Conditions - Flu, Pneumonia and COVID-19

Sponsor

University of Nottingham (Other)

Overall Status

Completed

CT.gov ID

NCT05115370

Collaborator

(none)

Enrollment

Location

2.4

Actual Duration (Months)

8.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

People with inflammatory diseases are often treated with medications that act to suppress the immune-system, increasing the risk of catching infections. Consequently, vaccination with the pneumonia and seasonal flu vaccines is recommended for them. They were also prioritised to receive the COVID-19 vaccines early in the national rollout.

However, the uptake of the pneumonia and seasonal flu vaccines among this group is lower than ideal. There may be many reasons why they do or do not seek to be vaccinated for these infections, such as the belief it may cause their disease to flare up or lack of knowledge of vaccines effectiveness. Anecdotally there was a high uptake of COVID-19 vaccines in adults with inflammatory conditions, however, concerns about vaccine-induced disease flare-ups and reports of complications deterred some from being vaccinated. A better understanding of why people do and do not seek vaccination may result in more targeted messaging for patients to help overcome vaccine hesitancy for these infectious diseases.

This study aims to explore the drivers and barriers to being vaccinated among adults with common inflammatory conditions and on immune-suppressing medication. They will be invited to participate 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. They will explore participants' understanding of pneumonia, seasonal flu and COVID-19 and the risk they pose to their health, their understanding of vaccinations, beliefs of the benefits and risks of vaccinations for these infections, and reasons for seeking or not seeking vaccination.

Findings will inform messaging about being vaccinated for these infections in patient education leaflets, such as those by patient charities regularly provided at speciality clinics. They will also be disseminated to healthcare professionals to help them better understand the drivers and barriers to vaccination.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Disease Rheumatoid Arthritis Psoriatic Arthritis Systemic Lupus Erythematosus Ankylosing Spondylitis Vasculitis Reactive Arthritis Inflammatory Bowel Diseases	Other: Semi-structured qualitative interview

Study Design

Study Type:

Observational

Actual Enrollment :

20 participants

Observational Model:

Other

Time Perspective:

Other

Official Title:

Barriers and Facilitators of Flu, Pneumonia and SARS-CoV-2 (COVID-19) Vaccination in Adults With Inflammatory Conditions Treated With Immune-suppressing Drugs

Actual Study Start Date :

Nov 1, 2021

Actual Primary Completion Date :

Jan 14, 2022

Actual Study Completion Date :

Jan 14, 2022

Arms and Interventions

Arm	Intervention/Treatment
Patients with an inflammatory disease taking immune-suppressing medication	Other: Semi-structured qualitative interview A single semi-structured qualitative interview conducted face-to-face or by telephone or video-conference call.

Arm

Intervention/Treatment

Patients with an inflammatory disease taking immune-suppressing medication

Other: Semi-structured qualitative interview

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

Outcome Measures

Primary Outcome Measures

Participants' understanding of the flu, pneumonia and Covid-19 respiratory infections and the risks they pose to the health and well-being of people on immune-suppressing treatments [1 day]
This will be determined through interview
Participants' understanding regarding vaccinations for these infections and how they work [1 day]
This will be determined through interview
Participants' views about the perceived benefits and risks of vaccination for these infections [1 day]
This will be determined through interview
The reasons for vaccine uptake versus vaccine hesitancy [1 day]
This will be determined through interview
The impact of the Covid-19 pandemic on perceptions and engagement with routinely administered vaccinations in this population. [1 day]
This will be determined through interview

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age at-least 18 years,
Diagnosed with either rheumatoid arthritis, inflammatory bowel disease, psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, vasculitis (small or large vessel), or reactive arthritis, and
At-least one prescription of either methotrexate, azathioprine, 5-mercaptopurine, sulfasalazine, mycophenolate mofetil, leflunomide, ciclosporin, tacrolimus, or sirolimus, biologic agents (such as anti-TNF, anti-CD 20 etc).
Ability to give informed consent