COVID-19 Vaccine Hesitancy Among Rheumatic Diseases Patients

NCT04775563 | Completed

• 1 other identifier: IRE-3639
• Study Type: observational
• Target: 891
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

vaccines, rheumatic diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  At study inclusion

Study Arms (1)

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; Other: COVID-19 vaccine hesitancy associated factors

Interventions

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.

Rheumatic diseases outpatients

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

Rheumatic diseases outpatients

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All the rheumatic diseases outpatients from the National Institute of Medical Sciences and Nutrition and General Hospital.

You may qualify if:

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

You may not qualify if:

• Patients with a not confirmed rheumatic disease

Sponsors & Collaborators

• National Institute of Medical Sciences and Nutrition, Salvador Zubiran: lead

Study Sites (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, 14080, Mexico

Location

MeSH Terms

Conditions

COVID-19; Rheumatic Diseases

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: March 1, 2021
• Study Start: February 1, 2021
• Primary Completion: August 30, 2021
• Study Completion: October 1, 2021
• Last Updated: April 6, 2022

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)