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COVID-19 Vaccine Hesitancy Among Rheumatic Diseases Patients

COVID-19 Vaccine Hesitancy Among Mexican Rheumatic Diseases Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04775563
Enrollment
891
Registered
2021-03-01
Start date
2021-02-01
Completion date
2021-10-01
Last updated
2022-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Keywords

vaccines, rheumatic diseases

Brief summary

Rheumatological diseases (RD) are an important group of different clinical entities and specific diseases that affect a significant proportion of the world population. In Mexico, the RD have a relevant representation in the adult population. COVID-19 vaccination has been proposed as a measure to contain the COVID-19 pandemic. The vaccines have been shown to be effective and reasonably safe in the population without significant risk factors, which has allowed their approval to attend the health emergency. At present, there is little scientific information that allows a solid recommendation on vaccination for COVID-19 in patients with RD, although most authorities have spoken in favor of vaccination in immunocompromised patients, as are a relevant number of patients with RD. However, it is desirable to achieve herd immunity to facilitate the impact of vaccination on the transmission of SARS-CoV-2 infection. For this, it is required that around 70% -80% of the target population be vaccinated, which implies not only access to the vaccine but also accepting to be vaccinated. Vaccine hesitancy is defined as the delay or refusal to accept the vaccine when it is available by health services. Sometimes, they conceptualize it as a continuum and also includes the high demand from the population for the vaccine; In this continuum, there are variations in acceptance and rejection and multiple possible combinations, from acceptance with great concern about the decision to rejection of certain vaccines but not others. It is a complex, contextual, changing phenomenon, specific for each vaccine and the referred disease and probably influenced by cultural determinants.

Detailed description

The objectives are: 1. \- To measure the phenomenon of vaccine hesitancy in Mexican patients with RD from two Health Institutions in Mexico City. 2. \- Translate and adapt the Oxford Covid-19 vaccine hesitancy scale to patients with RD and validate this version in a population of patients with RD from two Health Institutions in Mexico City 3. Explore factors associated with the phenomenon of vaccine hesitancy.

Interventions

OTHERCOVID-19 vaccine hesitancy scale in rheumatic diseases

The instrument was developed by Freeman et al, prior to its application, translation, cultural adaptation, and validation were performed.

OTHERCOVID-19 vaccine hesitancy associated factors

The instrument includes questions about the doctor-patient relationship, perception of the COVID-19 vaccine, perception of risk of COVID-19 infection, perception of the severity of the pandemic in Mexico, perception of the severity of their rheumatic disease, perception of the control of comorbidities, perception of the intensity of the immunosuppressive treatment, positioning of the patient towards vaccines for COVID-19

Sponsors

National Institute of Medical Sciences and Nutrition, Salvador Zubiran
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years

Inclusion criteria

* Patients with a rheumatic disease diagnosis according to their primary rheumatologist who agree to participate

Exclusion criteria

* Patients with a not confirmed rheumatic disease

Design outcomes

Primary

MeasureTime frameDescription
Measure the phenomenon of vaccine hesitancy among rheumatic diseases patientsAt study inclusionIdentify the percentage of patients with rheumatic diseases that present COVID-19 vaccine hesitancy using the instrument developed by Freeman et al (translation, cultural adaptation, and validation performed)

Secondary

MeasureTime frameDescription
Identify factors associated with COVID-19 vaccine hesitancy among rheumatic diseases patientsAt study inclusionIdentify factors associated with COVID-19 vaccine hesitancy among rheumatic diseases patients using an instrument locally development

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026