COVID-19 Vaccine Hesitancy Among Rheumatic Diseases Patients

Covid19 Clinical Trial

Official title:

COVID-19 Vaccine Hesitancy Among Mexican Rheumatic Diseases Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04775563
• Other study ID #: IRE-3639
• Status: Completed
• Start date: February 1, 2021
• Est. completion date: October 1, 2021

Study information

• Verified date: February 2021
• Source: National Institute of Medical Sciences and Nutrition, Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 891
• Est. completion date: October 1, 2021
• Est. primary completion date: August 30, 2021
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Collagen Diseases
• COVID-19
• Covid19
• Rheumatic Diseases

Intervention

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.
• 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

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the phenomenon of vaccine hesitancy among rheumatic diseases patients	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)	At study inclusion
Secondary	Identify factors associated with COVID-19 vaccine hesitancy among rheumatic diseases patients	Identify factors associated with COVID-19 vaccine hesitancy among rheumatic diseases patients using an instrument locally development	At study inclusion