Covid19NCT04775563
COVID-19 Vaccine Hesitancy Among Rheumatic Diseases Patients
An observational study of Covid19, run by National Institute of Medical Sciences and Nutrition, Salvador Zubiran at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Covid19
- What is being tested?
- COVID-19 vaccine hesitancy scale in rheumatic diseases and COVID-19 vaccine hesitancy associated factors
- Type of treatment
- Vaccines
- How many people
- 891 participants
- Where
- 1 siteMexico
- Study dates
- 1 Feb 2021to 1 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Adult, Older adult
Study population: All the rheumatic diseases outpatients from the National Institute of Medical Sciences and Nutrition and General Hospital.
Who may be able to join
- Patients with a rheumatic disease diagnosis according to their primary rheumatologist who agree to participate
Who cannot join
- Patients with a not confirmed rheumatic disease
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, 14080
About this study
Official title: COVID-19 Vaccine Hesitancy Among Mexican Rheumatic Diseases Patients
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.
Read the detailed description
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.
- Conditions
- Covid19
- Being tested
- COVID-19 vaccine hesitancy scale in rheumatic diseases, COVID-19 vaccine hesitancy associated factors
- Keywords
- vaccines, rheumatic diseases
- Medical subject headings
- COVID-19, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 vaccine hesitancy scale in rheumatic diseasesOther
The instrument was developed by Freeman et al, prior to its application, translation, cultural adaptation, and validation were performed.
COVID-19 vaccine hesitancy associated factorsOther
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
| Study group | Role | What they receive |
|---|---|---|
| Rheumatic diseases outpatients | All the rheumatic diseases outpatients from the National Institute of Medical Sciences and General Hospital. Receives: Other: COVID-19 vaccine hesitancy scale in rheumatic diseases; Other: COVID-19 vaccine hesitancy associated factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At study inclusion
Secondary outcomes (1)
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
Measured: At study inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start1 Feb 2021
- Primary completion30 Aug 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 891 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Medical Sciences and Nutrition, Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Virginia Pascual Ramos, National Institute of Medical Sciences and Nutrition, Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775563
- Sponsor's protocol ID
- IRE-3639
- Status last verified
- Feb 2021
- First submitted
- 24 Feb 2021
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Vaccine Hesitancy Among Mexican Rheumatic Diseases Patients
- ClinicalTrials.gov ID
- NCT04775563
- Acronym / sponsor ID
- IRE-3639
- Conditions
- Covid19
- Keywords
- vaccines, rheumatic diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 891 participants (actual)
- Lead sponsor
- National Institute of Medical Sciences and Nutrition, Salvador ZubiranUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- - 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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rheumatic diseases outpatients | – | Other: COVID-19 vaccine hesitancy scale in rheumatic diseases, Other: COVID-19 vaccine hesitancy associated factorsAll the rheumatic diseases outpatients from the National Institute of Medical Sciences and General Hospital. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All the rheumatic diseases outpatients from the National Institute of Medical Sciences and Nutrition and General Hospital.
Key inclusion criteria (1 listed)
- Patients with a rheumatic disease diagnosis according to their primary rheumatologist who agree to participate
Key exclusion criteria (1 listed)
- Patients with a not confirmed rheumatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 vaccine hesitancy scale in rheumatic diseasesThe instrument was developed by Freeman et al, prior to its application, translation, cultural adaptation, and validation were performed. | Other | Rheumatic diseases outpatients |
| COVID-19 vaccine hesitancy associated factorsThe 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 | Other | Rheumatic diseases outpatients |
Primary outcome
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)
1 secondary outcome
Identify factors associated with COVID-19 vaccine hesitancy among rheumatic diseases patients
Time frame: At study inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by National Institute of Medical Sciences and Nutrition, Salvador Zubiran at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the phenomenon of vaccine hesitancy among rheumatic diseases patients (time frame: At study inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.