Clinical trial NCT04775563: COVID-19 Vaccine Hesitancy Among Rheumatic Diseases Patients
Official title: COVID-19 Vaccine Hesitancy Among Mexican Rheumatic Diseases Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: vaccines, rheumatic diseases
Lead sponsor: National Institute of Medical Sciences and Nutrition, Salvador Zubiran
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 891
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All the rheumatic diseases outpatients from the National Institute of Medical Sciences and Nutrition and General Hospital.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Measure the phenomenon of vaccine hesitancy among rheumatic diseases patients
timeFrame: At study inclusion
Secondary outcomes:
measure: Identify factors associated with COVID-19 vaccine hesitancy among rheumatic diseases patients
timeFrame: At study inclusion
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Study officials:
References: