Collaborative Outcomes Study on Health and Functioning During Infection Times During COVID-19 Pandemic (COH-FIT)

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).

Study Overview

• Status: Unknown
• Conditions: Mental Health Wellness 1; Pandemic

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 100000

Contacts and Locations

• Study Contact: Name: Marco Solmi, MD; Phone Number: +390498213829; Email: marco.solmi@unipd.it
• Study Contact Backup: Name: Marco Solmi, MD; Email: marco.solmi@unipd.it

Study Locations

• Greece
  • Thessaloníki, Greece
    • Recruiting
    • Aristotle University Of Thessaloniki
    • Contact: Agorastos Agorastos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

General population

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mental health symptoms, well-being change from last 2 weeks before the pandemic to last 2 weeks during COVID-19 pandemic	Primary outcome in the wave 1 survey, conducted during the COVID-19 pandemic, will be mean change in visual analogue scale-assessed transdiagnostic measures across all psychiatric symptoms, and World Health Organization (WHO)-5 well-being in the last 2 weeks compared to the last 2 weeks of "regular life" before the COVID-19 outbreak. For WHO-5 the raw score ranges from 0 (absence of well-being) to 25 (maximal well-being).	wave 1 - change from last 2 weeks before pandemic to the following from April 26th 2020 on, until the pandemic will be over as declared by WHO (we estimate between October 2020 and April 2021)
Mental health symptoms, well-being change from last 2 weeks before the pandemic to last 2 weeks 6 months after WHO declares pandemic over COVID-19 pandemic	Primary outcome in the wave 2 survey, conducted during the COVID-19 pandemic, will be mean change in visual analogue scale-assessed transdiagnostic measures across all psychiatric symptoms and World Health Organization (WHO)-5 well-being in the last 2 weeks six months after the COVID-19 pandemic ended, compared to the last 2 weeks of "regular life" before the COVID-19 outbreak. For WHO-5 the raw score ranges from 0 (absence of well-being) to 25 (maximal well-being).	wave 2 - change from before to 6 months after pandemic
Mental health symptoms change, well-being change from last 2 weeks before the pandemic to last 2 weeks 12 months after WHO declares pandemic over COVID-19 pandemic	Primary outcome in the wave 3 survey, conducted during the COVID-19 pandemic, will be mean change in visual analogue scale-assessed transdiagnostic measures across all psychiatric symptoms and World Health Organization (WHO)-5 well-being in the last 2 weeks 12 months after the COVID-19 pandemic ended, compared to the last 2 weeks of "regular life" before the COVID-19 outbreak. For WHO-5 the raw score ranges from 0 (absence of well-being) to 25 (maximal well-being).	wave 3 - change from before to 12 months after pandemic (after the pandemic outbreak has been declared from WHO, and until the pandemic outbreak has been declared conlucded by WHO)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in alcohol abuse, as change in units used from last 2 weeks before the pandemic to last 2 weeks during pandemic	Change in alcohol abuse, as change in units used from last 2 weeks before the pandemic to last 2 weeks during pandemic	wave 1 - change from last 2 weeks before pandemic to the following from April 26th 2020 on, until the pandemic will be over as declared by WHO (we estimate between October 2020 and April 2021)
Change in cigarettes use, as change in number of cigarettes per day from last 2 weeks before the pandemic to last 2 weeks during pandemic	Change in cigarettes use, as change in number of cigarettes per day from last 2 weeks before the pandemic to last 2 weeks during pandemic	wave 1 - change from last 2 weeks before pandemic to the following from April 26th 2020 on, until the pandemic will be over as declared by WHO (we estimate between October 2020 and April 2021)
Change in grams of cannabinoids smoked from last 2 weeks before the pandemic to last 2 weeks during pandemic	Change in grams of cannabinoids smoked from last 2 weeks before the pandemic to last 2 weeks during pandemic	wave 1 - change from last 2 weeks before pandemic to the following from April 26th 2020 on, until the pandemic will be over as declared by WHO (we estimate between October 2020 and April 2021)
Change in alcohol abuse, as change in units used from last 2 weeks before the pandemic to last 2 weeks during pandemic	Change in alcohol abuse, as change in units used from last 2 weeks before the pandemic to last 2 weeks during pandemic	wave 2 - change from before to 6 months after pandemic
Change in cigarettes use, as change in number of cigarettes per day from last 2 weeks before the pandemic to last 2 weeks during pandemic	Change in cigarettes use, as change in number of cigarettes per day from last 2 weeks before the pandemic to last 2 weeks during pandemic	wave 2 - change from before to 6 months after pandemic
Change in grams of cannabinoids smoked from last 2 weeks before the pandemic to last 2 weeks during pandemic	Change in grams of cannabinoids smoked from last 2 weeks before the pandemic to last 2 weeks during pandemic	wave 2 - change from before to 6 months after pandemic
Change in alcohol abuse, as change in units used from last 2 weeks before the pandemic to last 2 weeks during pandemic	Change in alcohol abuse, as change in units used from last 2 weeks before the pandemic to last 2 weeks during pandemic	wave 3 - change from before to 12 months after pandemic
Change in cigarettes use, as change in number of cigarettes per day from last 2 weeks before the pandemic to last 2 weeks during pandemic	Change in cigarettes use, as change in number of cigarettes per day from last 2 weeks before the pandemic to last 2 weeks during pandemic	wave 3 - change from before to 12 months after pandemic
Change in grams of cannabinoids smoked from last 2 weeks before the pandemic to last 2 weeks during pandemic	Change in grams of cannabinoids smoked from last 2 weeks before the pandemic to last 2 weeks during pandemic	wave 3 - change from before to 12 months after pandemic
Change in general physical health, self-rated, on a VAS scale from 0 to 100.	Change in general physical health, self-rated, on a VAS scale from 0 to 100.	wave 1 - change from last 2 weeks before pandemic to the following from April 26th 2020 on, until the pandemic will be over as declared by WHO (we estimate between October 2020 and April 2021)
Change in general physical health, self-rated, on a VAS scale from 0 to 100.	Change in general physical health, self-rated, on a VAS scale from 0 to 100.	wave 2 - change from before to 6 months after pandemic
Change in general physical health, self-rated, on a VAS scale from 0 to 100.	Change in general physical health, self-rated, on a VAS scale from 0 to 100.	wave 3 - change from before to 12 months after pandemic
Change in general mental health, self-rated, on a VAS scale from 0 to 100.	Change in general mental health, self-rated, on a VAS scale from 0 to 100.	wave 1 - change from last 2 weeks before pandemic to the following from April 26th 2020 on, until the pandemic will be over as declared by WHO (we estimate between October 2020 and April 2021)
Change in general mental health, self-rated, on a VAS scale from 0 to 100.	Change in general mental health, self-rated, on a VAS scale from 0 to 100.	wave 2 - change from before to 6 months after pandemic
Change in general mental health, self-rated, on a VAS scale from 0 to 100.	Change in general mental health, self-rated, on a VAS scale from 0 to 100.	wave 3 - change from before to 12 months after pandemic
Change in easiness of access to care, self-rated a on a VAS scale from 0 to 100.	Change in easiness of access to care, self-rated a on a VAS scale from 0 to 100.	wave 1 - change from last 2 weeks before pandemic to the following from April 26th 2020 on, until the pandemic will be over as declared by WHO (we estimate between October 2020 and April 2021)
Change in easiness of access to care, self-rated a on a VAS scale from 0 to 100.	Change in easiness of access to care, self-rated a on a VAS scale from 0 to 100.	wave 2 - change from before to 6 months after pandemic
Change in easiness of access to care, self-rated a on a VAS scale from 0 to 100.	Change in easiness of access to care, self-rated a on a VAS scale from 0 to 100.	wave 3 - change from before to 12 months after pandemic
Change in medication adherence, self-rated a on a VAS scale from 0 to 100.	Change in medication adherence, self-rated a on a VAS scale from 0 to 100.	wave 1 - change from last 2 weeks before pandemic to the following from April 26th 2020 on, until the pandemic will be over as declared by WHO (we estimate between October 2020 and April 2021)
Change in medication adherence, self-rated a on a VAS scale from 0 to 100.	Change in medication adherence, self-rated a on a VAS scale from 0 to 100.	wave 2 - change from before to 6 months after pandemic
Change in medication adherence, self-rated a on a VAS scale from 0 to 100.	Change in medication adherence, self-rated a on a VAS scale from 0 to 100.	wave 3 - change from before to 12 months after pandemic
Change in functioning in self-care, school/work, social, and family, self-rated a on a VAS scale from 0 to 100.	Change in functioning in self-care, school/work, social, and family, self-rated a on a VAS scale from 0 to 100.	wave 1 - change from last 2 weeks before pandemic to the following from April 26th 2020 on, until the pandemic will be over as declared by WHO (we estimate between October 2020 and April 2021)
Change in functioning in self-care, school/work, social, and family, self-rated a on a VAS scale from 0 to 100.	Change in functioning in self-care, school/work, social, and family, self-rated a on a VAS scale from 0 to 100.	wave 2 - change from before to 6 months after pandemic
Change in functioning in self-care, school/work, social, and family, self-rated a on a VAS scale from 0 to 100.	Change in functioning in self-care, school/work, social, and family, self-rated a on a VAS scale from 0 to 100.	wave 3 - change from before to 12 months after pandemic

Collaborators and Investigators

• Sponsor: University of Padova
• Collaborators: Northwell Health; Donald and Barbara Zucker School of Medicine at Hofstra/Northwell
• Investigators: Principal Investigator: Christoph U. Correll, MD, Northwell Health; Principal Investigator: Marco Solmi, MD, University of Padova; Study Director: Agorastos Agorastos, MD, Aristotle University Of Thessaloniki; Study Director: Andres Estradè, MSc, Universidad Católica del Uruguay

Publications and helpful links

Helpful Links

• COH-FIT website
• COH-FIT Survey

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 26, 2020
• Primary Completion (ANTICIPATED): December 1, 2021
• Study Completion (ANTICIPATED): June 1, 2022

Study Registration Dates

• First Submitted: April 27, 2020
• First Submitted That Met QC Criteria: May 6, 2020
• First Posted (ACTUAL): May 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 14, 2020
• Last Update Submitted That Met QC Criteria: May 12, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Infection; Mental Health; COVID-19; Resilience; Physical Health
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Infections
• Other Study ID Numbers: COH-FIT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No