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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

Tracking Information
First Submitted Date April 20, 2020
First Posted Date April 30, 2020
Last Update Posted Date April 30, 2020
Actual Study Start Date April 3, 2020
Estimated Primary Completion Date April 3, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 28, 2020)
  • 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)
  • 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)
  • 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)
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: April 28, 2020)
  • 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)
  • 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)
  • Social life [ Time Frame: through study completion, estimated to 8 months ]
    Frequency of interacting with other people (daily, weekly, monthly, less often than monthly)
  • 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)
  • 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
  • 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
  • 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
  • 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
  • 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)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants will be recruited from 3 groups: general population, individuals with chronic illnesses, and healthcare professionals
Condition
  • COVID-19
  • Chronic Disease
  • Psychiatric Disorder
  • Cardiovascular Diseases
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Robillard R, Saad M, Edwards J, Solomonova E, Pennestri MH, Daros A, Veissière 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 28, 2020)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 3, 2021
Estimated Primary Completion Date April 3, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All individuals who are at least 12 years of age

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: All
Ages 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Rébecca Robillard, PhD 613-722-6521 ext 6279 rebecca.robillard@uottawa.ca
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT04369690
Other Study ID Numbers 2131
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: Undecided
Responsible Party Rébecca Robillard, University of Ottawa
Study Sponsor University of Ottawa
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
Investigators
Principal Investigator: Rébecca Robillard, PhD University of Ottawa
PRS Account University of Ottawa
Verification Date April 2020