Clinical trial NCT04369690: The Psychological, Social, and Economic Impacts of COVID-19
Official title: How Are You Coping? Assessing the Psychological, Social, and Economic Impacts of an Emerging Pandemic
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Chronic Disease
Psychiatric Disorder
Cardiovascular Diseases
Keywords: COVID-19
pandemic
psychology
social interactions
financial impacts
mental health
stress
anxiety
depression
healthcare professional's health
familly
sleep
occupational life
survey
social media
access to care
social distancing
Lead sponsor: University of Ottawa
Sponsor class: OTHER
Collaborators: name: Hopital du Sacre-Coeur de Montreal
name: Sunnybrook Health Sciences Centre
name: Southlake Regional Health Centre
name: The Ottawa Hospital Research Institute
name: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
name: Centre for Addiction and Mental Health
name: Cheo Research Institute
name: Ottawa Heart Institute Research Corporation
name: McGill University
name: Johns Hopkins University
name: Université de Montréal
name: The Royal's Institute of Mental Health Research
First posted: 2020-04-30
Enrollment: 1000
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from 3 groups: general population, individuals with chronic illnesses, and healthcare professionals

Brief summary: A dynamic analytical tool is being implemented to monitor the health, psychosocial and economic impacts of the COVID-19 pandemic as the crisis unfolds. A longitudinal survey is distributed via a network of hospitals, provincial/national organizations and web platforms. The survey information can be linked to provincial health administrative data and metrics derived from social media activity based on artificial intelligence methods. Targeted questions are included for critical populations such as healthcare workers and people with chronic illnesses.

Detailed description: The current situation unfolding with regards to the COVID-19 virus is changing core aspects of people's lives in a unique manner. This study aims to examine the psychological, social, and financial impacts of the COVID-19 pandemic at various stages of the outbreak.

Individuals 12 years and older are recruited from three main groups: general population, people with chronic illnesses and healthcare professionals.

An online survey is distributed via multiple hospitals, provincial/national organizations, and web-based platforms at various phases of the outbreak. The survey includes validated questionnaires and custom-made questions to asses the current situation. It notably addresses the following themes: demographics, COVID-19 symptoms and diagnoses, social distancing practices and social interactions, living situation, financial situation, family and work-related challenges, access to healthcare, as well as sleep, physical and mental health.

The survey is available in English and French. It is built on a decisional tree structure with customized subsets of questions based on previous answers.The survey contains an adolescent version and an adult version, and also includes targeted questions for individuals with a current diagnosis of a mental/medical illness. Consent is also sought to link data from parent-child dyads to enable finer analyses of family dynamics. Healthcare staff are invited to answer questions about work-related difficulties, usefulness of virtual tools for clinical practice, as well as moral distress and moral resilience in the context of clinical practice. Healthcare staff who are short on time can chose fill out an abbreviated version. Participants have the option of enabling linkage to linked to provincial health administrative data, and to provide their twitter and facebook handle for social media and mood monitoring through artificial intelligence algorithms. Participants have the option of being followed longitudinally during and after the outbreak.

Eligibility criteria: Inclusion Criteria:

* All individuals who are at least 12 years of age

Exclusion Criteria:

* None

Primary outcomes:
measure: Mental health - Stress
timeFrame: through study completion, estimated to 8 months
measure: Mental health - Anxiety
timeFrame: through study completion, estimated to 8 months
measure: Mental health - Depression
timeFrame: through study completion, estimated to 8 months
Secondary outcomes:
measure: Moral distress in healthcare workers
timeFrame: through study completion, estimated to 8 months
measure: Moral resilience in healthcare workers
timeFrame: through study completion, estimated to 8 months
measure: Social life
timeFrame: through study completion, estimated to 8 months
measure: COVID-9 symptoms
timeFrame: through study completion, estimated to 8 months
measure: Adverse health long-term outcome
timeFrame: 5 years before the outbreak and two years after
measure: Health care utilization - Inpatient
timeFrame: 5 years before the outbreak and two years after
measure: Health care utilization - ER
timeFrame: 5 years before the outbreak and two years after
measure: Health care utilization - Outpatient
timeFrame: 5 years before the outbreak and two years after
measure: Sleep
timeFrame: through study completion, estimated to 8 months
Other outcomes:
Locations:
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
state: Ontario
city: Ottawa
country: Canada
facility: CHEO Research Institute
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital Research Institute
state: Ontario
city: Ottawa
country: Canada
facility: The Centre for Addiction and Mental Health
state: Ontario
city: Ottawa
country: Canada
facility: The University of Ottawa Heart Institute
state: Ontario
city: Ottawa
country: Canada
facility: The Royal's Institute of Mental Health Research
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Montréal
country: Canada
facility: Hôpital en santé mentale Rivière-des-Prairies (CIUSSS du Nord-de-l'Île-de-Montréal)
state: Quebec
city: Montréal
country: Canada
facility: McGill University
state: Quebec
city: Montréal
country: Canada
facility: University of Montréal
state: Quebec
Study officials:
affiliation: University of Ottawa
name: Rébecca Robillard, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Robillard R, Saad M, Edwards J, Solomonova E, Pennestri MH, Daros A, Veissiere SPL, Quilty L, Dion K, Nixon A, Phillips J, Bhatla R, Spilg E, Godbout R, Yazji B, Rushton C, Gifford WA, Gautam M, Boafo A, Swartz R, Kendzerska T. Social, financial and psychological stress during an emerging pandemic: observations from a population survey in the acute phase of COVID-19. BMJ Open. 2020 Dec 12;10(12):e043805. doi: 10.1136/bmjopen-2020-043805.