COVID-19 Vaccine Hesitancy Among Rheumatic Diseases Patients
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|ClinicalTrials.gov Identifier: NCT04775563|
Recruitment Status : Recruiting
First Posted : March 1, 2021
Last Update Posted : March 1, 2021
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.
|Condition or disease||Intervention/treatment|
|Covid19||Other: COVID-19 vaccine hesitancy scale in rheumatic diseases Other: COVID-19 vaccine hesitancy associated factors|
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.
|Study Type :||Observational|
|Estimated Enrollment :||740 participants|
|Official Title:||COVID-19 Vaccine Hesitancy Among Mexican Rheumatic Diseases Patients|
|Actual Study Start Date :||February 1, 2021|
|Estimated Primary Completion Date :||August 30, 2021|
|Estimated Study Completion Date :||October 1, 2021|
Rheumatic diseases outpatients
All the rheumatic diseases outpatients from the National Institute of Medical Sciences and General Hospital.
Other: COVID-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.
Other: COVID-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
- 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)
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04775563
|Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán||Recruiting|
|Mexico City, Mexico, 14080|
|Contact: Virginia Pascual-Ramos, MD 00525555734111 ext 533 firstname.lastname@example.org|