- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05115370
Vaccination Perception in Inflammatory Conditions - Flu, Pneumonia and COVID-19 (OPINION)
Barriers and Facilitators of Flu, Pneumonia and SARS-CoV-2 (COVID-19) Vaccination in Adults With Inflammatory Conditions Treated With Immune-suppressing Drugs
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Nottinghamshire
-
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
- University of Nottingham
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Exclusion Criteria:
- Age < 18 years
- Dementia: making it impossible to give informed consent and to comply with interview
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with an inflammatory disease taking immune-suppressing medication
|
A single semi-structured qualitative interview conducted face-to-face or by telephone or video-conference call.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 1 day
|
This will be determined through interview
|
1 day
|
Participants' understanding regarding vaccinations for these infections and how they work
Time Frame: 1 day
|
This will be determined through interview
|
1 day
|
Participants' views about the perceived benefits and risks of vaccination for these infections
Time Frame: 1 day
|
This will be determined through interview
|
1 day
|
The reasons for vaccine uptake versus vaccine hesitancy
Time Frame: 1 day
|
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.
Time Frame: 1 day
|
This will be determined through interview
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Abhishek Abhishek, University of Nottingham
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Autoimmune Diseases
- Lung Diseases
- Gastrointestinal Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Connective Tissue Diseases
- Gastroenteritis
- Intestinal Diseases
- Skin Diseases, Papulosquamous
- Spinal Diseases
- Bone Diseases
- Spondylarthropathies
- Spondylarthritis
- Psoriasis
- Bone Diseases, Infectious
- Ankylosis
- Arthritis, Infectious
- Arthritis
- Lupus Erythematosus, Systemic
- Inflammatory Bowel Diseases
- Pneumonia
- Arthritis, Psoriatic
- Vasculitis
- Spondylitis
- Spondylitis, Ankylosing
- Arthritis, Reactive
Other Study ID Numbers
- 21054
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rheumatoid Arthritis
-
Janssen Research & Development, LLCWithdrawnActive Rheumatoid Arthritis; Rheumatoid Arthritis
-
Centocor, Inc.CompletedRheumatoid Arthritis, Juvenile
-
AmgenTerminated
-
Children's Hospital Medical Center, CincinnatiNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedJuvenile Rheumatoid ArthritisUnited States
-
AmgenImmunex CorporationCompletedJuvenile Rheumatoid Arthritis
-
National Institute of Arthritis and Musculoskeletal...Children's Hospital Medical Center, CincinnatiCompleted
-
University of PittsburghNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedRheumatoid Arthritis | Juvenile Rheumatoid ArthritisUnited States
-
University of Missouri-ColumbiaCompletedJuvenile Rheumatoid ArthritisUnited States
-
Assistance Publique - Hôpitaux de ParisSociete Francaise de RhumatologieRecruiting
-
Amsterdam UMC, location VUmcEuropean CommissionCompletedRheumatoId ArthritisNetherlands, Germany, Portugal, Italy, Hungary, Romania, Slovakia
Clinical Trials on Semi-structured qualitative interview
-
City, University of LondonUniversity College London HospitalsCompletedMultiple SclerosisUnited Kingdom
-
University of Colorado, DenverOrthotic and Prosthetic Education and Research Foundation (OPERF)Active, not recruiting
-
University Hospital, MontpellierRecruiting
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Multiple Sclerosis | Parkinson Disease | Rehabilitation | Neurologic Disorder | NeurosurgeryItaly
-
Assistance Publique - Hôpitaux de ParisCompleted
-
Hospices Civils de LyonCompleted
-
University of OxfordCompletedCeliac Disease | Mental Health Wellness 1 | Emotional Problem | Stigma, Social | Celiac Disease in Children | Celiac | DisclosureUnited Kingdom
-
University Hospital, BordeauxCompleted
-
University Hospital, GrenobleNot yet recruitingSchizophrenia | Schizophrenia Schizoaffective
-
The Hong Kong Polytechnic UniversityRecruitingIntensive Care Units, PediatricHong Kong