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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
Sponsor:
Information provided by (Responsible Party):
Virginia Pascual Ramos, National Institute of Medical Sciences and Nutrition, Salvador Zubiran

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.


Condition or disease Intervention/treatment
Covid19 Other: COVID-19 vaccine hesitancy scale in rheumatic diseases Other: COVID-19 vaccine hesitancy associated factors

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.

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Study Type : Observational
Estimated Enrollment : 740 participants
Observational Model: Other
Time Perspective: Cross-Sectional
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

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
All the rheumatic diseases outpatients from the National Institute of Medical Sciences and Nutrition and General Hospital.
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

Information from the National Library of Medicine

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


Locations
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Mexico
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán Recruiting
Mexico City, Mexico, 14080
Contact: Virginia Pascual-Ramos, MD    00525555734111 ext 533    virtichu@gmail.com   
Sponsors and Collaborators
National Institute of Medical Sciences and Nutrition, Salvador Zubiran
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Responsible Party: Virginia Pascual Ramos, PI, National Institute of Medical Sciences and Nutrition, Salvador Zubiran
ClinicalTrials.gov Identifier: NCT04775563    
Other Study ID Numbers: IRE-3639
First Posted: March 1, 2021    Key Record Dates
Last Update Posted: March 1, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Virginia Pascual Ramos, National Institute of Medical Sciences and Nutrition, Salvador Zubiran:
vaccines, rheumatic diseases
Additional relevant MeSH terms:
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Rheumatic Diseases
Collagen Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs