Clinical trial NCT04383470: Collaborative Outcomes Study on Health and Functioning During Infection Times During COVID-19 Pandemic
Official title: Collaborative Outcomes Study on Health and Functioning During Infection Times During COVID-19 Pandemic
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mental Health Wellness 1
Pandemic
Keywords: COVID-19
Mental Health
Physical Health
Infection
Resilience
Lead sponsor: University of Padova
Sponsor class: OTHER
Collaborators: name: Northwell Health
name: Donald and Barbara Zucker School of Medicine at Hofstra/Northwell
First posted: 2020-05-12
Enrollment: 100000
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General population

Brief 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mental health symptoms, well-being change from last 2 weeks before the pandemic to last 2 weeks during COVID-19 pandemic
timeFrame: 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)
measure: 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
timeFrame: wave 2 - change from before to 6 months after pandemic
measure: 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
timeFrame: 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 outcomes:
measure: Change in alcohol abuse, as change in units used from last 2 weeks before the pandemic to last 2 weeks during pandemic
timeFrame: 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)
measure: 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
timeFrame: 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)
measure: Change in grams of cannabinoids smoked from last 2 weeks before the pandemic to last 2 weeks during pandemic
timeFrame: 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)
measure: Change in alcohol abuse, as change in units used from last 2 weeks before the pandemic to last 2 weeks during pandemic
timeFrame: wave 2 - change from before to 6 months after pandemic
measure: 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
timeFrame: wave 2 - change from before to 6 months after pandemic
measure: Change in grams of cannabinoids smoked from last 2 weeks before the pandemic to last 2 weeks during pandemic
timeFrame: wave 2 - change from before to 6 months after pandemic
measure: Change in alcohol abuse, as change in units used from last 2 weeks before the pandemic to last 2 weeks during pandemic
timeFrame: wave 3 - change from before to 12 months after pandemic
measure: 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
timeFrame: wave 3 - change from before to 12 months after pandemic
measure: Change in grams of cannabinoids smoked from last 2 weeks before the pandemic to last 2 weeks during pandemic
timeFrame: wave 3 - change from before to 12 months after pandemic
measure: Change in general physical health, self-rated, on a VAS scale from 0 to 100.
timeFrame: 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)
measure: Change in general physical health, self-rated, on a VAS scale from 0 to 100.
timeFrame: wave 2 - change from before to 6 months after pandemic
measure: Change in general physical health, self-rated, on a VAS scale from 0 to 100.
timeFrame: wave 3 - change from before to 12 months after pandemic
measure: Change in general mental health, self-rated, on a VAS scale from 0 to 100.
timeFrame: 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)
measure: Change in general mental health, self-rated, on a VAS scale from 0 to 100.
timeFrame: wave 2 - change from before to 6 months after pandemic
measure: Change in general mental health, self-rated, on a VAS scale from 0 to 100.
timeFrame: wave 3 - change from before to 12 months after pandemic
measure: Change in easiness of access to care, self-rated a on a VAS scale from 0 to 100.
timeFrame: 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)
measure: Change in easiness of access to care, self-rated a on a VAS scale from 0 to 100.
timeFrame: wave 2 - change from before to 6 months after pandemic
measure: Change in easiness of access to care, self-rated a on a VAS scale from 0 to 100.
timeFrame: wave 3 - change from before to 12 months after pandemic
measure: Change in medication adherence, self-rated a on a VAS scale from 0 to 100.
timeFrame: 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)
measure: Change in medication adherence, self-rated a on a VAS scale from 0 to 100.
timeFrame: wave 2 - change from before to 6 months after pandemic
measure: Change in medication adherence, self-rated a on a VAS scale from 0 to 100.
timeFrame: wave 3 - change from before to 12 months after pandemic
measure: Change in functioning in self-care, school/work, social, and family, self-rated a on a VAS scale from 0 to 100.
timeFrame: 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)
measure: Change in functioning in self-care, school/work, social, and family, self-rated a on a VAS scale from 0 to 100.
timeFrame: wave 2 - change from before to 6 months after pandemic
measure: Change in functioning in self-care, school/work, social, and family, self-rated a on a VAS scale from 0 to 100.
timeFrame: wave 3 - change from before to 12 months after pandemic
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: Aristotle University of Thessaloniki
Study officials:
affiliation: Northwell Health
name: Christoph U. Correll, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Padova
name: Marco Solmi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aristotle University Of Thessaloniki
name: Agorastos Agorastos, MD
role: STUDY_DIRECTOR
affiliation: Universidad Católica del Uruguay
name: Andres Estradè, MSc
role: STUDY_DIRECTOR
References: