- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04369690
The Psychological, Social, and Economic Impacts of COVID-19 (C19Survey)
How Are You Coping? Assessing the Psychological, Social, and Economic Impacts of an Emerging Pandemic
Study Overview
Status
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Ontario
-
Newmarket, Ontario, Canada, L3Y 2P9
- Not yet recruiting
- Southlake Regional Health Centre
-
Contact:
- Janet Jeffrey, RN, PhD
- Email: jjeffrey@southlakeregional.org
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Principal Investigator:
- Janet Jeffrey, RN, PhD
-
Ottawa, Ontario, Canada, K1Z 7K4
- Recruiting
- The Royal's Institute of Mental Health Research
-
Contact:
- Rébecca Robillard
- Phone Number: 6279 613-722-6521
- Email: rebecca.robillard@uottawa.ca
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Principal Investigator:
- Rébecca Robillard, PhD
-
Sub-Investigator:
- Zachary Kaminsky, PhD
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Sub-Investigator:
- Raj Bhatla, MD FRCPC
-
Sub-Investigator:
- Mysa Saad, MSc
-
Sub-Investigator:
- Jennifer Phillips, PhD
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Ottawa, Ontario, Canada, K1H 5B2
- Recruiting
- CHEO Research Institute
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Contact:
- Addo Boafo, MD
- Phone Number: 2703 613-737-7600
- Email: ABoafo@cheo.on.ca
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Principal Investigator:
- Addo Boafo, MD
-
Ottawa, Ontario, Canada, K1H 8L6
- Recruiting
- The Ottawa Hospital Research Institute
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Contact:
- Tetyana Kendzerska, MD PhD
- Phone Number: 2765 (613) 798-5555
- Email: tkendzerska@toh.ca
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Principal Investigator:
- Tetyana Kendzerska, MD, PhD
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Sub-Investigator:
- Edward Spilg, FRCP, MSc
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Sub-Investigator:
- Mamta Gautam, FRCP MBA
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Sub-Investigator:
- Cynda Rushton, RN, PhD
-
Sub-Investigator:
- Wendy Gifford, RN, PhD
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Ottawa, Ontario, Canada, K1S 1V7
- Not yet recruiting
- The Centre for Addiction and Mental Health
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Contact:
- Lena Quilty, PhD, CPsych
- Phone Number: 34313 416-535-8501
- Email: lena.quilty@camh.ca
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Principal Investigator:
- Lena Quilty, PhD, CPsych
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Sub-Investigator:
- Alexander Daros, PhD, CPsych
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Ottawa, Ontario, Canada, K1Y 4W7
- Recruiting
- The University of Ottawa Heart Institute
-
Contact:
- Jodi Edwards, PhD
- Phone Number: 15336 613 696 7000
- Email: Jedwards@ottawaheart.ca
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Principal Investigator:
- Jodi Edwards, PhD
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Toronto, Ontario, Canada, M4N 3M5
- Not yet recruiting
- Sunnybrook Health Sciences Centre
-
Contact:
- Richard Swartz, MD, PhD
- Phone Number: 416-480-4866
- Email: rick.swartz@sunnybrook.ca
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Contact:
- Kaitlyn Lopes
- Phone Number: (647) 502-0524
- Email: kaitlyn.lopes@sunnybrook.ca
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Principal Investigator:
- Richard H Swartz, MD, PhD
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Quebec
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Montréal, Quebec, Canada, H1E 1A4
- Not yet recruiting
- Hôpital en santé mentale Rivière-des-Prairies (CIUSSS du Nord-de-l'Île-de-Montréal)
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Contact:
- Roger Godbout, PhD
- Phone Number: 2657 514 323-7260
- Email: roger.godbout@umontreal.ca
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Principal Investigator:
- Roger Godbout, PhD
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Sub-Investigator:
- Marie-Hélène Pennestri, PhD
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Montréal, Quebec, Canada, H3A 0G4
- Not yet recruiting
- McGill University
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Contact:
- Marie-Hélène Pennestri, PhD
- Phone Number: (514) 398-8079
- Email: marie-helene.pennestri@mcgill.ca
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Principal Investigator:
- Marie-Hélène Pennestri, PhD
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Sub-Investigator:
- Elizaveta Solomonova, PhD
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Sub-Investigator:
- Samuel Paul Louis Veissière, PhD
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Montréal, Quebec, Canada, H3T 1J4
- Not yet recruiting
- University of Montreal
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Contact:
- Denis Lafortune, PhD
- Email: denis.lafortune@umontreal.ca
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Principal Investigator:
- Denis Lafortune, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All individuals who are at least 12 years of age
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mental health - Stress
Time Frame: through study completion, estimated to 8 months
|
Cohen's Perceived Stress Scale (scores ranged from 0 to 40, higher scores indicating worse stress)
|
through study completion, estimated to 8 months
|
|
Mental health - Anxiety
Time Frame: through study completion, estimated to 8 months
|
Generalized Anxiety Disorder Scale (scores ranged from 0 to 21, higher scores indicating worse anxiety)
|
through study completion, estimated to 8 months
|
|
Mental health - Depression
Time Frame: 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)
|
through study completion, estimated to 8 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Moral distress in healthcare workers
Time Frame: 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)
|
through study completion, estimated to 8 months
|
|
Moral resilience in healthcare workers
Time Frame: through study completion, estimated to 8 months
|
Rushton Moral Resilience Scale (scores ranged from 1 to 4, higher scores indicating more resiliency)
|
through study completion, estimated to 8 months
|
|
Social life
Time Frame: through study completion, estimated to 8 months
|
Frequency of interacting with other people (daily, weekly, monthly, less often than monthly)
|
through study completion, estimated to 8 months
|
|
COVID-9 symptoms
Time Frame: 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)
|
through study completion, estimated to 8 months
|
|
Adverse health long-term outcome
Time Frame: 5 years before the outbreak and two years after
|
Mortality (Yes/No): https://datadictionary.ices.on.ca/Applications/DataDictionary/Default.aspx
|
5 years before the outbreak and two years after
|
|
Health care utilization - Inpatient
Time Frame: 5 years before the outbreak and two years after
|
Hospitalizations (total number): https://datadictionary.ices.on.ca/Applications/DataDictionary/Default.aspx
|
5 years before the outbreak and two years after
|
|
Health care utilization - ER
Time Frame: 5 years before the outbreak and two years after
|
Emergency Department visits (Total number): https://datadictionary.ices.on.ca/Applications/DataDictionary/Default.aspx
|
5 years before the outbreak and two years after
|
|
Health care utilization - Outpatient
Time Frame: 5 years before the outbreak and two years after
|
Outpatient visits: https://datadictionary.ices.on.ca/Applications/DataDictionary/Default.aspx
|
5 years before the outbreak and two years after
|
|
Sleep
Time Frame: through study completion, estimated to 8 months
|
Pittsburgh Sleep Quality Index (scores ranged from 0 to 21, higher scores indicating worse sleep disturbances)
|
through study completion, estimated to 8 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Rébecca Robillard, PhD, University of Ottawa
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Pathologic Processes
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Disease Attributes
- COVID-19
- Cardiovascular Diseases
- Problem Behavior
- Mental Disorders
- Chronic Disease
Other Study ID Numbers
- 2131
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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