Collaborative Outcomes Study on Health and Functioning During Infection Times During COVID-19 Pandemic

NCT ID: NCT04383470

Last Updated: 2020-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-26

Study Completion Date

2022-06-30

Brief Summary

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Observational, cross-sectional, multi-center, multi-wave survey, assessing characteristics and predictors of physical and mental health as well as health behaviors during COVID-19 pandemic, targeting the general population (children, adolescents and adults).

Detailed Description

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In March 2020, the World Health Organization declared the COVID-19 (known as Coronavirus) virus a global pandemic. COVID-19 is a variant of coronavirus thought to originate in Wuhan province China. Up until April 7, 2020, as many as 1,346,299 individuals had confirmed COVID-19 infection, with already 74,679 deaths from COVID-19 complications.

The hypothesis of this study is that the physical and mental health of the general population and health care workers involved in the management of COVID-19 infected people is heavily affected by COVID-19, but that risk and protective factors exist.

Investigators plan to distribute 3 different surveys based on the age group. The first survey, COH-FIT-Adults/ (COH-FIT-A), will be distributed the general adult (age \>/= 18 years old) population in North America, South America, Europe, Asia, Africa and Australia via an online link, making the general population aware of the project via public announcements, social media and regular media coverage outlets, or via specialized institutes and agencies (e.g., opinion research centers) that are capable of using a randomly selected, nationally representative sample (potentially funded by national / local grant applications). For the subgroup of adult health-care professionals, additionally, survey distribution mechanisms will be used that utilize medical professional organizations and associations, hospital and university anonymized channels.

Guardians of adolescents aged 14-17 years old will be asked to provide electronic consent for their adolescent to participate in the COH-FIT-AD survey after having taken the survey and being familiar with the questions, being informed that the one question having sexuality as the content will be omitted from the adolescent version. Guardians of children aged 6-13 years old will be able to review the survey questions that children would answer before electronically consenting to participate.

Conditions

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Mental Health Wellness 1 Pandemic

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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General population, during COVID pandemic

General population during COVID-19 pandemic. Adults, adolescents, and children aged 6 years or older. People working in health-care, police, fire-, and military-service vs others. People with physical illness vs others. People with mental illness vs others. Different continents, countries, and regions.

No interventions assigned to this group

General population, 6 months after COVID pandemic

General population, 6 months after COVID pandemic Adults, adolescents, and children aged 6 years or older. People working in health-care, police, fire-, and military-service vs others. People with physical illness vs others. People with mental illness vs others. Different continents, countries, and regions.

No interventions assigned to this group

General population, 12 months after COVID pandemic

General population, 12 months after COVID pandemic Adults, adolescents, and children aged 6 years or older. People working in health-care, police, fire-, and military-service vs others. People with physical illness vs others. People with mental illness vs others. Different continents, countries, and regions.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* General population
* Consenting to the study (adults)
* Guardians consenting to study participation of children and adolescents

Exclusion Criteria

* Not consenting to the study (adults)
* Not assenting to the study (children and adolescents)
* age \< 6 years old
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Northwell Health

OTHER

Sponsor Role collaborator

Donald and Barbara Zucker School of Medicine at Hofstra/Northwell

UNKNOWN

Sponsor Role collaborator

University of Padova

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christoph U. Correll, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Marco Solmi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Padova

Agorastos Agorastos, MD

Role: STUDY_DIRECTOR

Aristotle University Of Thessaloniki

Andres Estradè, MSc

Role: STUDY_DIRECTOR

Universidad Católica del Uruguay

Locations

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Aristotle University of Thessaloniki

Thessaloniki, , Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Marco Solmi, MD

Role: CONTACT

+390498213829

Marco Solmi, MD

Role: CONTACT

Facility Contacts

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Agorastos Agorastos

Role: primary

Related Links

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Other Identifiers

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COH-FIT

Identifier Type: -

Identifier Source: org_study_id

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