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COVID-19C19SurveyNCT04369690

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

An observational study of COVID-19 and Chronic Disease, run by University of Ottawa at 10 sites in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 12 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19, Chronic Disease, Psychiatric Disorder
How many people
1,000 participants
Where
10 sitesCanada
Study dates
3 Apr 2020to 3 Apr 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Participants will be recruited from 3 groups: general population, individuals with chronic illnesses, and healthcare professionals

Who may be able to join

  • All individuals who are at least 12 years of age

Who cannot join

  • None

Trial locations and contacts

10 sites in 1 country.

Rébecca Robillard, PhD contact

613-722-6521 ext. 6279

rebecca.robillard@uottawa.ca

10 sites in 1 country

Canada10 sites, 10 recruiting

  • Hôpital en santé mentale Rivière-des-Prairies (CIUSSS du Nord-de-l'Île-de-Montréal)

    Montreal, Quebec, H1E 1A4

    Roger Godbout, PhD, 514 323-7260 ext. 2657, roger.godbout@umontreal.ca

    Roger Godbout, PhD

    Not yet recruiting

  • McGill University

    Montreal, Quebec, H3A 0G4

    Marie-Hélène Pennestri, PhD, (514) 398-8079, marie-helene.pennestri@mcgill.ca

    Marie-Hélène Pennestri, PhD

    Not yet recruiting

  • University of Montréal

    Montreal, Quebec, H3T 1J4

    Denis Lafortune, PhD, denis.lafortune@umontreal.ca

    Denis Lafortune, PhD

    Not yet recruiting

  • Southlake Regional Health Centre

    Newmarket, Ontario, L3Y 2P9

    Janet Jeffrey, RN, PhD, jjeffrey@southlakeregional.org

    Janet Jeffrey, RN, PhD

    Not yet recruiting

  • CHEO Research Institute

    Ottawa, Ontario, K1H 5B2

    Addo Boafo, MD, 613-737-7600 ext. 2703, ABoafo@cheo.on.ca

    Addo Boafo, MD

    Recruiting

  • The Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H 8L6

    Tetyana Kendzerska, MD PhD, (613) 798-5555 ext. 2765, tkendzerska@toh.ca

    Tetyana Kendzerska, MD, PhD

    Recruiting

  • The Centre for Addiction and Mental Health

    Ottawa, Ontario, K1S 1V7

    Lena Quilty, PhD, CPsych, 416-535-8501 ext. 34313, lena.quilty@camh.ca

    Lena Quilty, PhD, CPsych

    Not yet recruiting

  • The University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7

    Jodi Edwards, PhD, 613 696 7000 ext. 15336, Jedwards@ottawaheart.ca

    Jodi Edwards, PhD

    Recruiting

  • The Royal's Institute of Mental Health Research

    Ottawa, Ontario, K1Z 7K4

    Rébecca Robillard, 613-722-6521 ext. 6279, rebecca.robillard@uottawa.ca

    Rébecca Robillard, PhD

    Recruiting

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

    Richard Swartz, MD, PhD, 416-480-4866, rick.swartz@sunnybrook.ca

    Kaitlyn Lopes, (647) 502-0524, kaitlyn.lopes@sunnybrook.ca

    Not yet recruiting

Other trials in Canada

About this study

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

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.

Read the 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.

Keywords
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
Medical subject headings
COVID-19, Chronic Disease, Mental Disorders, Cardiovascular Diseases, Psychological Well-Being, Anxiety Disorders, Depression

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mental health - Stress

    Cohen's Perceived Stress Scale (scores ranged from 0 to 40, higher scores indicating worse stress)

    Measured: through study completion, estimated to 8 months

  2. Mental health - Anxiety

    Generalized Anxiety Disorder Scale (scores ranged from 0 to 21, higher scores indicating worse anxiety)

    Measured: through study completion, estimated to 8 months

  3. Mental health - Depression

    Quick Inventory of Depressive Symptomatology-Self-report, short version (scores ranged from 0 to 27, higher scores indicating worse depression)

    Measured: through study completion, estimated to 8 months

Secondary outcomes (9)

  1. Moral distress in healthcare workers

    Measure of Moral Distress - Healthcare Professionals (scores ranged from 0 to 432, higher scores indicating worse moral distress)

    Measured: through study completion, estimated to 8 months

  2. Moral resilience in healthcare workers

    Rushton Moral Resilience Scale (scores ranged from 1 to 4, higher scores indicating more resiliency)

    Measured: through study completion, estimated to 8 months

  3. Social life

    Frequency of interacting with other people (daily, weekly, monthly, less often than monthly)

    Measured: through study completion, estimated to 8 months

  4. 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)

    Measured: through study completion, estimated to 8 months

  5. Adverse health long-term outcome

    Mortality (Yes/No): https://datadictionary.ices.on.ca/Applications/DataDictionary/Default.aspx

    Measured: 5 years before the outbreak and two years after

  6. Health care utilization - Inpatient

    Hospitalizations (total number): https://datadictionary.ices.on.ca/Applications/DataDictionary/Default.aspx

    Measured: 5 years before the outbreak and two years after

  7. Health care utilization - ER

    Emergency Department visits (Total number): https://datadictionary.ices.on.ca/Applications/DataDictionary/Default.aspx

    Measured: 5 years before the outbreak and two years after

  8. Health care utilization - Outpatient

    Outpatient visits: https://datadictionary.ices.on.ca/Applications/DataDictionary/Default.aspx

    Measured: 5 years before the outbreak and two years after

  9. Sleep

    Pittsburgh Sleep Quality Index (scores ranged from 0 to 21, higher scores indicating worse sleep disturbances)

    Measured: through study completion, estimated to 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2020
  2. Study start3 Apr 2020
  3. Primary completion3 Apr 2021 (estimated)
  4. Study completion3 Apr 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04369690
Sponsor's protocol ID
2131
Acronym
C19Survey
Status last verified
Apr 2020
First submitted
20 Apr 2020
Last updated
30 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Undecided

Publications

  • Robillard R, Saad M, Edwards J, Solomonova E, Pennestri MH, Daros A, Veissiere 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.

    PubMed 33310814

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19 and Chronic Disease, run by University of Ottawa at 10 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Rébecca Robillard, PhD (613-722-6521 ext. 6279, rebecca.robillard@uottawa.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mental health - Stress (time frame: through study completion, estimated to 8 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04369690, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2020.

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