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OpenTrials
Completed

NCT Number: NCT04775563

COVID-19 Vaccine Hesitancy Among Rheumatic Diseases Patients

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, 14080, Mexico

About this study

The objectives are:

  • - To measure the phenomenon of vaccine hesitancy in Mexican patients with RD from two Health Institutions in Mexico City.
  • - 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
  • Explore factors associated with the phenomenon of vaccine hesitancy.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COVID-19 vaccine hesitancy scale in rheumatic diseases

Other

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

COVID-19 vaccine hesitancy associated factors

Other

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

Primary outcomes

  1. Measure the phenomenon of vaccine hesitancy among rheumatic diseases patients

    Time frame: At study inclusion

    Identify 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 outcomes

  1. Identify factors associated with COVID-19 vaccine hesitancy among rheumatic diseases patients

    Time frame: At study inclusion

    Identify factors associated with COVID-19 vaccine hesitancy among rheumatic diseases patients using an instrument locally development

Sponsors and collaborators

Lead sponsor

National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Other

Registry information

Official study title

COVID-19 Vaccine Hesitancy Among Mexican Rheumatic Diseases Patients

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 1, 2021
Registry last updated
Apr 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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