Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04369690
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : April 30, 2020
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Rébecca Robillard, University of Ottawa

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
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.

Layout table for study information
Study Type : Observational
Estimated 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 : April 3, 2020
Estimated Primary Completion Date : April 3, 2021
Estimated Study Completion Date : April 3, 2021



Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. Social life [ Time Frame: through study completion, estimated to 8 months ]
    Frequency of interacting with other people (daily, weekly, monthly, less often than monthly)

  4. 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)

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants will be recruited from 3 groups: general population, individuals with chronic illnesses, and healthcare professionals
Criteria

Inclusion Criteria:

  • All individuals who are at least 12 years of age

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04369690


Contacts
Layout table for location contacts
Contact: Rébecca Robillard, PhD 613-722-6521 ext 6279 rebecca.robillard@uottawa.ca

Locations
Layout table for location information
Canada, Ontario
Southlake Regional Health Centre Not yet recruiting
Newmarket, Ontario, Canada, L3Y 2P9
Contact: Janet Jeffrey, RN, PhD       jjeffrey@southlakeregional.org   
Principal Investigator: Janet Jeffrey, RN, PhD         
CHEO Research Institute Recruiting
Ottawa, Ontario, Canada, K1H 5B2
Contact: Addo Boafo, MD    613-737-7600 ext 2703    ABoafo@cheo.on.ca   
Principal Investigator: Addo Boafo, MD         
The Ottawa Hospital Research Institute Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Tetyana Kendzerska, MD PhD    (613) 798-5555 ext 2765    tkendzerska@toh.ca   
Principal Investigator: Tetyana Kendzerska, MD, PhD         
Sub-Investigator: Edward Spilg, FRCP, MSc         
Sub-Investigator: Mamta Gautam, FRCP MBA         
Sub-Investigator: Cynda Rushton, RN, PhD         
Sub-Investigator: Wendy Gifford, RN, PhD         
The Centre for Addiction and Mental Health Not yet recruiting
Ottawa, Ontario, Canada, K1S 1V7
Contact: Lena Quilty, PhD, CPsych    416-535-8501 ext 34313    lena.quilty@camh.ca   
Principal Investigator: Lena Quilty, PhD, CPsych         
Sub-Investigator: Alexander Daros, PhD, CPsych         
The University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Contact: Jodi Edwards, PhD    613 696 7000 ext 15336    Jedwards@ottawaheart.ca   
Principal Investigator: Jodi Edwards, PhD         
The Royal's Institute of Mental Health Research Recruiting
Ottawa, Ontario, Canada, K1Z 7K4
Contact: Rébecca Robillard    613-722-6521 ext 6279    rebecca.robillard@uottawa.ca   
Principal Investigator: Rébecca Robillard, PhD         
Sub-Investigator: Zachary Kaminsky, PhD         
Sub-Investigator: Raj Bhatla, MD FRCPC         
Sub-Investigator: Mysa Saad, MSc         
Sub-Investigator: Jennifer Phillips, PhD         
Sunnybrook Health Sciences Centre Not yet recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Richard Swartz, MD, PhD    416-480-4866    rick.swartz@sunnybrook.ca   
Contact: Kaitlyn Lopes    (647) 502-0524    kaitlyn.lopes@sunnybrook.ca   
Principal Investigator: Richard H Swartz, MD, PhD         
Canada, Quebec
Hôpital en santé mentale Rivière-des-Prairies (CIUSSS du Nord-de-l'Île-de-Montréal) Not yet recruiting
Montréal, Quebec, Canada, H1E 1A4
Contact: Roger Godbout, PhD    514 323-7260 ext 2657    roger.godbout@umontreal.ca   
Principal Investigator: Roger Godbout, PhD         
Sub-Investigator: Marie-Hélène Pennestri, PhD         
McGill University Not yet recruiting
Montréal, Quebec, Canada, H3A 0G4
Contact: Marie-Hélène Pennestri, PhD    (514) 398-8079    marie-helene.pennestri@mcgill.ca   
Principal Investigator: Marie-Hélène Pennestri, PhD         
Sub-Investigator: Elizaveta Solomonova, PhD         
Sub-Investigator: Samuel Paul Louis Veissière, PhD         
University of Montréal Not yet recruiting
Montréal, Quebec, Canada, H3T 1J4
Contact: Denis Lafortune, PhD       denis.lafortune@umontreal.ca   
Principal Investigator: Denis Lafortune, PhD         
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
Investigators
Layout table for investigator information
Principal Investigator: Rébecca Robillard, PhD University of Ottawa
Additional Information:
Layout table for additonal information
Responsible Party: Rébecca Robillard, Dr. Rebecca Robillard, University of Ottawa
ClinicalTrials.gov Identifier: NCT04369690    
Other Study ID Numbers: 2131
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rébecca Robillard, University of Ottawa:
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiovascular Diseases
Chronic Disease
Mental Disorders
Problem Behavior
Disease Attributes
Pathologic Processes
Behavioral Symptoms