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

NCT05115370 | Completed

• 1 other identifier: 21054
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Disease; Rheumatoid Arthritis; Psoriatic Arthritis; Systemic Lupus Erythematosus; Ankylosing Spondylitis; Vasculitis; Reactive Arthritis; Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (5)

• 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

  This will be determined through interview

  1 day

• Participants' understanding regarding vaccinations for these infections and how they work

  This will be determined through interview

  1 day

• Participants' views about the perceived benefits and risks of vaccination for these infections

  This will be determined through interview

  1 day

• The reasons for vaccine uptake versus vaccine hesitancy

  This will be determined through interview

  1 day

• The impact of the Covid-19 pandemic on perceptions and engagement with routinely administered vaccinations in this population.

  This will be determined through interview

  1 day

Study Arms (1)

Patients with an inflammatory disease taking immune-suppressing medication

Other: Semi-structured qualitative interview

Interventions

Semi-structured qualitative interview OTHER

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

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

Patients with an inflammatory condition and on immune-suppressing medication

You may qualify if:

• 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

You may not qualify if:

• Age \< 18 years
• Dementia: making it impossible to give informed consent and to comply with interview

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

University of Nottingham

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis, Psoriatic; Lupus Erythematosus, Systemic; Spondylitis, Ankylosing; Vasculitis; Arthritis, Reactive; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Arthritis; 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; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Axial Spondyloarthritis; Ankylosis; Vascular Diseases; Cardiovascular Diseases; Arthritis, Infectious; Infections; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Abhishek Abhishek

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: November 10, 2021
• Study Start: November 1, 2021
• Primary Completion: January 14, 2022
• Study Completion: January 14, 2022
• Last Updated: April 15, 2022

Record last verified: 2021-10

Locations

GB (1)