Health BehaviorNCT04771117
Defiances to Face COVID-19 Pandemic in Mexico
An observational study of Health Behavior and Risk-Taking, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial summary
The aim of this study is to identify the risk factors favoring the contagion of COVID-19 by studying the quarantine behavior and preventive measures in the Mexican population. As a secondary aim, the investigators sought to identify areas that need reinforcement, to help develop strategies for a successful plan to… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Risk-Taking, Covid19
- What is being tested?
- Fear of Covid-19 Scale
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 4,004 participants
- Where
- 1 siteMexico
- Study dates
- 1 May 2020to 1 Dec 2020
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study sample was the Mexican general population currently living in the covid-19 pandemic.
Who may be able to join
- Being Mexican or residents of the country
- Participants over 15 years
Who cannot join
- Participants under 15 years of age
- Participants with incomplete surveys
- Being a tourist currently staying in the country or being Mexican residing in another country
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to identify the risk factors favoring the contagion of COVID-19 by studying the quarantine behavior and preventive measures in the Mexican population. As a secondary aim, the investigators sought to identify areas that need reinforcement, to help develop strategies for a successful plan to face an upcoming pandemic.
- Conditions
- Health Behavior, Risk-Taking, Covid19
- Being tested
- Fear of Covid-19 Scale
- Keywords
- Health Behavior, Pandemic, Risk-Taking, Mexico, Covid-19
- Medical subject headings
- Health Behavior, Risk-Taking, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fear of Covid-19 ScaleBehavioural
The Fear of Covid-19 Scale (FCV-19S) is a questionnaire that evaluates fear of the global pandemic caused by the SARS-CoV-2. The FVC-19S consists of seven items, such as "It makes me uncomfortable to think about coronavirus-19," "I am afraid of losing my life because of coronavirus-19," and "When watching news and stories about coronavirus-19 on social media, I become nervous or anxious," each with a five-point Likert scale of options. The participant is instructed to choose the option that best represents their perception about the statement presented. The maximum possible total is 35 points. The scale's authors indicate that the higher the score is, the higher is the level of the participants' fear of COVID-19.
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk Factors
Risk factors favoring the contagion of COVID-19 by studying the quarantine behavior and preventive measures in the Mexican population.
Measured: Baseline
Secondary outcomes (1)
Fear of Covid-19
The Fear of Covid-19 Scale (FCV-19S) is a questionnaire that evaluates fear of the global pandemic caused by the SARS-CoV-2. The FVC-19S consists of seven items, such as "It makes me uncomfortable to think about coronavirus-19," "I am afraid of losing my life because of coronavirus-19," and "When watching news and stories about coronavirus-19 on social media, I become nervous or anxious," each with a five-point Likert scale of options. The participant is instructed to choose the option that best represents their perception about the statement presented. The maximum possible total is 35 points. The scale's authors indicate that the higher the score is, the higher is the level of the participants' fear of COVID-19.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start1 May 2020
- Primary completion1 Aug 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 4,004 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, GONZALEZ-OJEDA ALEJANDRO, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771117
- Sponsor's protocol ID
- Fear5
- Status last verified
- Feb 2021
- First submitted
- 3 Feb 2021
- Last updated
- 26 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ibarrola-Pena JC, Barbosa-Camacho FJ, Almanza-Mena YL, Chejfec-Ciociano JM, Reyes-Elizalde EA, Romero-Limon OM, Zaragoza-Organista R, Cervantes-Perez E, Sapien-Fernandez JH, Guzman-Barba JA, Flores-Becerril P, Ochoa-Rodriguez I, Najar-Hinojosa R, Cueto-Valadez AE, Cueto-Valadez TA, Lopez-Zendejas M, Fuentes-Orozco C, Cervantes-Guevara G, Miranda-Ackerman RC, Gonzalez-Ojeda A. Preventive measures against the COVID-19 pandemic in Mexico: A cross-sectional study. Front Public Health. 2022 Oct 11;10:932010. doi: 10.3389/fpubh.2022.932010. eCollection 2022.
PubMed 36304240
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defiances to Face COVID-19 Pandemic in Mexico
- ClinicalTrials.gov ID
- NCT04771117
- Acronym / sponsor ID
- Fear5
- Conditions
- Health Behavior, Risk-Taking, Covid19
- Keywords
- Health Behavior, Pandemic, Risk-Taking, Mexico, Covid-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,004 participants (actual)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 25 Feb 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.
The aim of this study is to identify the risk factors favoring the contagion of COVID-19 by studying the quarantine behavior and preventive measures in the Mexican population. As a secondary aim, the investigators sought to identify areas that need reinforcement, to help develop strategies for a successful plan to face an upcoming pandemic.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study sample was the Mexican general population currently living in the covid-19 pandemic.
Key inclusion criteria (2 listed)
- Being Mexican or residents of the country
- Participants over 15 years
Key exclusion criteria (3 listed)
- Participants under 15 years of age
- Participants with incomplete surveys
- Being a tourist currently staying in the country or being Mexican residing in another country
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 |
|---|---|---|
| Fear of Covid-19 ScaleThe Fear of Covid-19 Scale (FCV-19S) is a questionnaire that evaluates fear of the global pandemic caused by the SARS-CoV-2. The FVC-19S consists of seven items, such as "It makes me uncomfortable to think about coronavirus-19," "I am afraid of losing my life because of coronavirus-19," and "When watching news and stories about coronavirus-19 on social media, I become nervous or anxious," each with a five-point Likert scale of options. The participant is instructed to choose the option that best represents their perception about the statement presented. The maximum possible total is 35 points. The scale's authors indicate that the higher the score is, the higher is the level of the participants' fear of COVID-19. | Behavioural | – |
Primary outcome
Risk Factors
Time frame: Baseline
Risk factors favoring the contagion of COVID-19 by studying the quarantine behavior and preventive measures in the Mexican population.
1 secondary outcome
Fear of Covid-19
Time frame: Baseline
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 26 Feb 2021.
- Derived from this study: PubMed 36304240Ibarrola-Pena JC, Barbosa-Camacho FJ, Almanza-Mena YL, Chejfec-Ciociano JM, Reyes-Elizalde EA, Romero-Limon OM, Zaragoza-Organista R, Cervantes-Perez E, Sapien-Fernandez JH, Guzman-Barba JA, Flores-Becerril P, Ochoa-Rodriguez I, Najar-Hinojosa R, Cueto-Valadez AE, Cueto-Valadez TA, Lopez-Zendejas M, Fuentes-Orozco C, Cervantes-Guevara G, Miranda-Ackerman RC, Gonzalez-Ojeda A. Preventive measures against the COVID-19 pandemic in Mexico: A cross-sectional study. Front Public Health. 2022 Oct 11;10:932010. doi: 10.3389/fpubh.2022.932010. eCollection 2022.
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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 Health Behavior and Risk-Taking, run by Instituto Mexicano del Seguro Social 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 2 inclusion and 3 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 26 Feb 2021. 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?
Risk Factors (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04771117, which also lists 1 linked publication.
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 26 Feb 2021.