C19Survey: The Psychological, Social, and Economic Impacts of COVID-19

Sponsor

University of Ottawa (Other)

Overall Status

Unknown status

CT.gov ID

NCT04369690

Collaborator

Hopital du Sacre-Coeur de Montreal (Other), Sunnybrook Health Sciences Centre (Other), Southlake Regional Health Centre (Other), The Ottawa Hospital Research Institute (Other), Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal (Other), Centre for Addiction and Mental Health (Other), CHEO Research Institute (Other), Ottawa Heart Institute Research Corporation (Other), McGill University (Other), Johns Hopkins University (Other), Université de Montréal (Other), The Royal's Institute of Mental Health Research (Other)

1,000

Enrollment

Locations

Anticipated Duration (Months)

100

Patients Per Site

8.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Chronic Disease Psychiatric Disorder Cardiovascular Diseases

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

How Are You Coping? Assessing the Psychological, Social, and Economic Impacts of an Emerging Pandemic

Actual Study Start Date :

Apr 3, 2020

Anticipated Primary Completion Date :

Apr 3, 2021

Anticipated Study Completion Date :

Apr 3, 2021

Outcome Measures

Primary Outcome Measures

Mental health - Stress [through study completion, estimated to 8 months]
Cohen's Perceived Stress Scale (scores ranged from 0 to 40, higher scores indicating worse stress)
Mental health - Anxiety [through study completion, estimated to 8 months]
Generalized Anxiety Disorder Scale (scores ranged from 0 to 21, higher scores indicating worse anxiety)
Mental health - Depression [through study completion, estimated to 8 months]
Quick Inventory of Depressive Symptomatology-Self-report, short version (scores ranged from 0 to 27, higher scores indicating worse depression)

Secondary Outcome Measures

Moral distress in healthcare workers [through study completion, estimated to 8 months]
Measure of Moral Distress - Healthcare Professionals (scores ranged from 0 to 432, higher scores indicating worse moral distress)
Moral resilience in healthcare workers [through study completion, estimated to 8 months]
Rushton Moral Resilience Scale (scores ranged from 1 to 4, higher scores indicating more resiliency)
Social life [through study completion, estimated to 8 months]
Frequency of interacting with other people (daily, weekly, monthly, less often than monthly)
COVID-9 symptoms [through study completion, estimated to 8 months]
Fever, Cough, Difficulty breathing or shortness of breath, Tiredness, Aches and pains, Nasal congestion, Runny nose, Sore throat, Diarrhea (Mild Moderate, Severe, N/A)
Adverse health long-term outcome [5 years before the outbreak and two years after]
Mortality (Yes/No): https://datadictionary.ices.on.ca/Applications/DataDictionary/Default.aspx
Health care utilization - Inpatient [5 years before the outbreak and two years after]
Hospitalizations (total number): https://datadictionary.ices.on.ca/Applications/DataDictionary/Default.aspx
Health care utilization - ER [5 years before the outbreak and two years after]
Emergency Department visits (Total number): https://datadictionary.ices.on.ca/Applications/DataDictionary/Default.aspx
Health care utilization - Outpatient [5 years before the outbreak and two years after]
Outpatient visits: https://datadictionary.ices.on.ca/Applications/DataDictionary/Default.aspx
Sleep [through study completion, estimated to 8 months]
Pittsburgh Sleep Quality Index (scores ranged from 0 to 21, higher scores indicating worse sleep disturbances)

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

All individuals who are at least 12 years of age

Exclusion Criteria:

None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Southlake Regional Health Centre	Newmarket	Ontario	Canada	L3Y 2P9
2	CHEO Research Institute	Ottawa	Ontario	Canada	K1H 5B2
3	The Ottawa Hospital Research Institute	Ottawa	Ontario	Canada	K1H 8L6
4	The Centre for Addiction and Mental Health	Ottawa	Ontario	Canada	K1S 1V7
5	The University of Ottawa Heart Institute	Ottawa	Ontario	Canada	K1Y 4W7
6	The Royal's Institute of Mental Health Research	Ottawa	Ontario	Canada	K1Z 7K4
7	Sunnybrook Health Sciences Centre	Toronto	Ontario	Canada	M4N 3M5
8	Hôpital en santé mentale Rivière-des-Prairies (CIUSSS du Nord-de-l'Île-de-Montréal)	Montréal	Quebec	Canada	H1E 1A4
9	McGill University	Montréal	Quebec	Canada	H3A 0G4
10	University of Montréal	Montréal	Quebec	Canada	H3T 1J4

Sponsors and Collaborators

University of Ottawa
Hopital du Sacre-Coeur de Montreal
Sunnybrook Health Sciences Centre
Southlake Regional Health Centre
The Ottawa Hospital Research Institute
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Centre for Addiction and Mental Health
CHEO Research Institute
Ottawa Heart Institute Research Corporation
McGill University
Johns Hopkins University
Université de Montréal
The Royal's Institute of Mental Health Research