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

Mental Health Wellness 1 Clinical Trial

— COH-FIT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04383470
• Other study ID #: COH-FIT
• Status: Recruiting
• Start date: April 26, 2020
• Est. completion date: June 2022

Study information

• Verified date: May 2020
• Source: University of Padova
• Contact: Marco Solmi, MD
• Phone: +390498213829
• Email: marco.solmi[@]unipd.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100000
• Est. completion date: June 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infection
• Mental Health Wellness 1
• Pandemic

Locations

Country	Name	City	State
Greece	Aristotle University of Thessaloniki	Thessaloníki

Sponsors (3)

Lead Sponsor	Collaborator
University of Padova	Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Northwell Health

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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

External Links

•   COH-FIT Survey
•   COH-FIT website