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

COVID-19 Clinical Trial

— C19Survey  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04369690
• Other study ID #: 2131
• Status: Recruiting
• Start date: April 3, 2020
• Est. completion date: April 3, 2021

Study information

• Verified date: April 2020
• Source: University of Ottawa
• Contact: Rébecca Robillard, PhD
• Phone: 613-722-6521
• Email: rebecca.robillard[@]uottawa.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: April 3, 2021
• Est. primary completion date: April 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• All individuals who are at least 12 years of age

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Chronic Disease
• COVID-19
• Mental Disorders
• Problem Behavior
• Psychiatric Disorder

Locations

Country	Name	City	State
Canada	Hôpital en santé mentale Rivière-des-Prairies (CIUSSS du Nord-de-l'Île-de-Montréal)	Montréal	Quebec
Canada	McGill University	Montréal	Quebec
Canada	University of Montréal	Montréal	Quebec
Canada	Southlake Regional Health Centre	Newmarket	Ontario
Canada	CHEO Research Institute	Ottawa	Ontario
Canada	The Centre for Addiction and Mental Health	Ottawa	Ontario
Canada	The Ottawa Hospital Research Institute	Ottawa	Ontario
Canada	The Royal's Institute of Mental Health Research	Ottawa	Ontario
Canada	The University of Ottawa Heart Institute	Ottawa	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (13)

Lead Sponsor

Collaborator

University of Ottawa

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

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mental health - Stress	Cohen's Perceived Stress Scale (scores ranged from 0 to 40, higher scores indicating worse stress)	through study completion, estimated to 8 months
Primary	Mental health - Anxiety	Generalized Anxiety Disorder Scale (scores ranged from 0 to 21, higher scores indicating worse anxiety)	through study completion, estimated to 8 months
Primary	Mental health - Depression	Quick Inventory of Depressive Symptomatology-Self-report, short version (scores ranged from 0 to 27, higher scores indicating worse depression)	through study completion, estimated to 8 months
Secondary	Moral distress in healthcare workers	Measure of Moral Distress - Healthcare Professionals (scores ranged from 0 to 432, higher scores indicating worse moral distress)	through study completion, estimated to 8 months
Secondary	Moral resilience in healthcare workers	Rushton Moral Resilience Scale (scores ranged from 1 to 4, higher scores indicating more resiliency)	through study completion, estimated to 8 months
Secondary	Social life	Frequency of interacting with other people (daily, weekly, monthly, less often than monthly)	through study completion, estimated to 8 months
Secondary	COVID-9 symptoms	Fever, Cough, Difficulty breathing or shortness of breath, Tiredness, Aches and pains, Nasal congestion, Runny nose, Sore throat, Diarrhea (Mild Moderate, Severe, N/A)	through study completion, estimated to 8 months
Secondary	Adverse health long-term outcome	Mortality (Yes/No): https://datadictionary.ices.on.ca/Applications/DataDictionary/Default.aspx	5 years before the outbreak and two years after
Secondary	Health care utilization - Inpatient	Hospitalizations (total number): https://datadictionary.ices.on.ca/Applications/DataDictionary/Default.aspx	5 years before the outbreak and two years after
Secondary	Health care utilization - ER	Emergency Department visits (Total number): https://datadictionary.ices.on.ca/Applications/DataDictionary/Default.aspx	5 years before the outbreak and two years after
Secondary	Health care utilization - Outpatient	Outpatient visits: https://datadictionary.ices.on.ca/Applications/DataDictionary/Default.aspx	5 years before the outbreak and two years after
Secondary	Sleep	Pittsburgh Sleep Quality Index (scores ranged from 0 to 21, higher scores indicating worse sleep disturbances)	through study completion, estimated to 8 months

External Links

•   Survey link