The Covid-19 HEalth caRe wOrkErS (HEROES) Study

Sponsor
University of Chile (Other)
Overall Status
Recruiting
CT.gov ID
NCT04352634
Collaborator
Columbia University (Other)
2,000
22
20.2
90.9
4.5

Study Details

Study Description

Brief Summary

Since December 2019 the world has been shaken with an enormous global threat: the Covid-19 pandemic. This new kind of coronavirus is generating an unprecedented impact both on the general population and on the healthcare systems in most countries. Health services are trying to expand their capacity to respond to the pandemic, taking actions such as increasing the number of beds; acquiring necessary equipment to provide intensive therapy (ventilators), and calling retired health professionals and health students so they can assist the overwhelmed health care workforce. Unfortunately, these organizational changes at health facilities, along with the fears and concerns of becoming ill with the virus or infecting their families, put an enormous emotional burden on workers in health services which may lead to negative outcomes on mental health in this population.

Recent cross-sectional studies in China indicate that health service workers exposed to people with Covid-19 reported higher rates of depressive and anxious symptoms. This negative impact on mental health among health workers in China has also been informally reported in other countries where the Covid-19 pandemic has been devastating in its effects (such as Spain and Italy), as well as in countries where the pandemic is becoming a growing public health problem. This is particularly relevant in regions with fewer resources (Latin America, North Africa), where there are limited means and the response from the health system is usually insufficient. Moreover, it is necessary to study these negative effects longitudinally considering that some effects will appear over time (post-traumatic stress).

The COVID-19 HEalth caRe wOrkErS (HEROES) study is a large, bottom-up, South-North initiative aimed to evaluate the impact of the COVID-19 pandemic on the mental health of health care workers (HCWs). HEROES encompasses a wide variety of academic institutions in 19 LMICs and 8 HICs, in partnership with the Pan American Health Organization (PAHO) and with support from the World Health Organization (WHO). The HEROES study is led by Dr. Rubén Alvarado at University of Chile, and Dr. Ezra Susser and Franco Mascayano at Columbia U Mailman School of Public Health.

Condition or Disease Intervention/Treatment Phase
  • Other: Exposure to the SARS-CoV-2 and its consequences

Detailed Description

Since December 2019 the world has been shaken with an enormous global threat: the Covid-19 pandemic. This new kind of coronavirus is generating an unprecedented impact both on the general population and on the healthcare systems in most countries. Health services are trying to expand their capacity to respond to the pandemic, taking actions such as increasing the number of beds; acquiring necessary equipment to provide intensive therapy (ventilators), and calling retired health professionals and health students so they can assist the overwhelmed health care workforce. Unfortunately, these organizational changes at health facilities, along with the fears and concerns of becoming ill with the virus or infecting their families, put an enormous emotional burden on workers in health services which may lead to negative outcomes on mental health in this population. Based on the literature to date, Covid-19 is significantly larger than previous pandemics in terms of the number of affected people worldwide, its spread across countries, its impact on healthcare systems and the severity of measures that have been taken by governments. Immediate consequences are palpable in the health care system. Many healthcare workers are overwhelmed by the increased workload; the lack of supplies and materials to provide appropriate treatment; the lack of clinical guidelines on prioritization and triage; and the increased feelings of isolation and loneliness. Previous research indicates that these negative effects can last over time and lead to the development of serious mental health problems such as post-traumatic stress disorder.

Recent cross-sectional studies in China indicate that health service workers exposed to people with Covid-19 reported higher rates of depressive and anxious symptoms. This negative impact on mental health among health workers in China has also been informally reported in other countries where the Covid-19 pandemic has been devastating in its effects (such as Spain and Italy), as well as in countries where the pandemic is becoming a growing public health problem. This is particularly relevant in regions with fewer resources (Latin America, North Africa), where there are limited means and the response from the health system is usually insufficient. Moreover, it is necessary to study these negative effects longitudinally considering that some effects will appear over time (post-traumatic stress). Also, it is necessary to take into account the nature and the extent of the health response (e.g., deployment, increased workload) in order to advance our understanding of these complex phenomenon and to inform policy and develop the kind of supports that this population deems useful.

The COVID-19 HEalth caRe wOrkErS (HEROES) study is a large, bottom-up, South-North initiative aimed to evaluate the impact of the COVID-19 pandemic on the mental health of health care workers (HCWs). HEROES encompasses a wide variety of academic institutions in 19 LMICs and 8 HICs, in partnership with the Pan American Health Organization (PAHO) and with support from the World Health Organization (WHO). The HEROES study is led by Dr. Rubén Alvarado at University of Chile, and Dr. Ezra Susser and Franco Mascayano at Columbia U Mailman School of Public Health.

Participants will complete an online questionnaire, which will be completely self-administered. It will take approximately 12 minutes and includes sociodemographic data, questions on work activity, training, fears and concerns related to Covid-19, as well as the GHQ-12 and a series of questions on other mental health issues (e.g., suicide, acute stress), resilience and psycho/social factors (e.g., formal and informal support).

Study Design

Study Type:
Observational
Anticipated Enrollment :
2000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Impact of the Covid-19 Pandemic on the Mental Health of Workers in Health Services: The Covid-19 HEalth caRe wOrkErS (HEROES) Study
Actual Study Start Date :
Apr 26, 2020
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Healthcare workers

Workers who interact with people with confirmed or suspected COVID-19 at different health services (primary care centers, emergency units, specialized care units, inpatient care units, critically ill patient units, among others). Potential participants will include any type of worker in these centers, including clinical and administrative staff, as well as supportive staff (e.g., food services)

Other: Exposure to the SARS-CoV-2 and its consequences
This is an observational design. Participants are exposed to the SARS-CoV-2, the Covid-19 pandemic, and/or its consequences

Outcome Measures

Primary Outcome Measures

  1. Anxiety and depressive symptoms [12 months]

    The 12-item version of the General Health Questionnaire (GHQ-12) is a self-reported instrument that measures symptoms of anxiety and depression. It provides cut-off points to identify people at risk of anxiety and/or depression, which differ slightly between countries

Secondary Outcome Measures

  1. Experiences, fears and concerns about the Covid-19 [Baseline]

    Ad hoc survey on experiences, fears, and concerns about Covid-19

  2. Experiences, fears and concerns about the Covid-19 [3 months]

    Ad hoc survey on experiences, fears, and concerns about Covid-19

  3. Experiences, fears and concerns about the Covid-19 [6 months]

    Ad hoc survey on experiences, fears, and concerns about Covid-19

  4. Experiences, fears and concerns about the Covid-19 [12 months]

    Ad hoc survey on experiences, fears, and concerns about Covid-19

  5. Training and resource prioritization [Baseline]

    Ad hoc survey on Covid-19 training and resource prioritization

  6. Training and resource prioritization [3 months]

    Ad hoc survey on Covid-19 training and resource prioritization

  7. Training and resource prioritization [6 months]

    Ad hoc survey on Covid-19 training and resource prioritization

  8. Training and resource prioritization [12 months]

    Ad hoc survey on Covid-19 training and resource prioritization

  9. Suicide ideation (presence) [Baseline]

    Item from the Columbia Suicide Severity Rating Scale (C-SSRS) that measures suicidal ideation with a dichotomous answer (presence/absence)

  10. Suicide ideation (presence) [3 months]

    Item from the Columbia Suicide Severity Rating Scale (C-SSRS) that measures suicidal ideation with a dichotomous answer (presence/absence)

  11. Suicide ideation (presence) [6 months]

    Item from the Columbia Suicide Severity Rating Scale (C-SSRS) that measures suicidal ideation with a dichotomous answer (presence/absence)

  12. Suicide ideation (presence) [12 months]

    Item from the Columbia Suicide Severity Rating Scale (C-SSRS) that measures suicidal ideation with a dichotomous answer (presence/absence)

  13. Suicide ideation (frequency) [Baseline]

    5-point Likert item from the Columbia Suicide Severity Rating Scale (C-SSRS). Higher scores indicate higher frequency.

  14. Suicide ideation (frequency) [3 months]

    5-point Likert item from the Columbia Suicide Severity Rating Scale (C-SSRS). Higher scores indicate higher frequency.

  15. Suicide ideation (frequency) [6 months]

    5-point Likert item from the Columbia Suicide Severity Rating Scale (C-SSRS). Higher scores indicate higher frequency.

  16. Suicide ideation (frequency) [12 months]

    5-point Likert item from the Columbia Suicide Severity Rating Scale (C-SSRS). Higher scores indicate higher frequency.

  17. Acute stress symptoms [Baseline]

    Ad hoc 3-item survey to evaluate acute stress disorder. Higher values of the 5-points Likert scales suggest higher frequency of symptoms

  18. Acute stress symptoms [3 months]

    Ad hoc 3-item survey to evaluate acute stress disorder. Higher values of the 5-points Likert scales suggest higher frequency of symptoms

  19. Acute stress symptoms [6 months]

    Ad hoc 3-item survey to evaluate acute stress disorder. Higher values of the 5-points Likert scales suggest higher frequency of symptoms

  20. Acute stress symptoms [12 months]

    Ad hoc 3-item survey to evaluate acute stress disorder. Higher values of the 5-points Likert scales suggest higher frequency of symptoms

  21. Psycho/social support and network [Baseline]

    Ad hoc survey on support network. The answers to the multiple items will be adjusted so higher values indicate higher levels of psychological and social support

  22. Psycho/social support and network [3 months]

    Ad hoc survey on support network. The answers to the multiple items will be adjusted so higher values indicate higher levels of psychological and social support

  23. Psycho/social support and network [6 months]

    Ad hoc survey on support network. The answers to the multiple items will be adjusted so higher values indicate higher levels of psychological and social support

  24. Psycho/social support and network [12 months]

    Ad hoc survey on support network. The answers to the multiple items will be adjusted so higher values indicate higher levels of psychological and social support

  25. Resilience [Baseline]

    The Brief Resilience Scale (BRS) is a 6-item self-reported instrument that measures resilience. The range of scores is 6-30. Higher scores indicate higher resilience levels.

  26. Resilience [3 months]

    The Brief Resilience Scale (BRS) is a 6-item self-reported instrument that measures resilience. The range of scores is 6-30. Higher scores indicate higher resilience levels.

  27. Resilience [6 months]

    The Brief Resilience Scale (BRS) is a 6-item self-reported instrument that measures resilience. The range of scores is 6-30. Higher scores indicate higher resilience levels.

  28. Resilience [12 months]

    The Brief Resilience Scale (BRS) is a 6-item self-reported instrument that measures resilience. The range of scores is 6-30. Higher scores indicate higher resilience levels.

  29. Anxiety and depressive symptoms [Baseline]

    The 12-item version of the General Health Questionnaire (GHQ-12) is a self-reported instrument that measures symptoms of anxiety and depression. It provides cut-off points to identify people at risk of anxiety and/or depression, which differ slightly between countries

  30. Anxiety and depressive symptoms [3 months]

    The 12-item version of the General Health Questionnaire (GHQ-12) is a self-reported instrument that measures symptoms of anxiety and depression. It provides cut-off points to identify people at risk of anxiety and/or depression, which differ slightly between countries

  31. Anxiety and depressive symptoms [6 months]

    The 12-item version of the General Health Questionnaire (GHQ-12) is a self-reported instrument that measures symptoms of anxiety and depression. It provides cut-off points to identify people at risk of anxiety and/or depression, which differ slightly between countries

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Legal age

  • Currently working on a health service that provides care to COVID-19 patients

  • Give informed consent

Exclusion Criteria:
  • Inability to use electronic devices (required to complete the survey)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Columbia University New York New York United States 10032
2 Universidad del Chubut Rawson Chubut Argentina 9103
3 National Institute of Health Named After Academician S. Avdalbekyan Yerevan Armenia 0051
4 University of Sydney Sidney New South Wales Australia 2031
5 Salud Global Sucre Chuquisaca Bolivia
6 University of Chile Santiago Chile
7 Universidad Nacional de Costa Rica Heredia Costa Rica 863000
8 Society for Emergecy and Disaster Medicine CzMA JEP Kladno Bohemia Czechia 27201
9 Hochschule Emden/Leer Emden Niedersachsen Germany 26723
10 Centro de Investigaciones de las Ciencias de la Salud -CICS- Facultad de Ciencias Médicas Universidad de San Carlos de Guatemala -USAC- Guatemala City Guatemala 01011
11 University of Cagliari Cagliari CA Italy 09124
12 University of Cagliari Cagliari Italy
13 The Institute for Development Research Advocacy and Applied Care (IDRAAC) Beirut Lebanon 11002110
14 Logotipo del comercio Instituto Jalisciense De Salud Mental (SALME) Guadalajara Jalisco Mexico 45170
15 Maastricht University Maastricht Limburg Netherlands 6229
16 University of Ibadan Ibadan Oyo State Nigeria 200220
17 Ponce Health Sciences University Ponce Puerto Rico 00716
18 King Abdullah International medical research center Riyadh Central Saudi Arabia 11522
19 Hospital La Paz Institute for Health Research (IdiPAZ) Madrid Spain 28046
20 Razi Hospital La Manouba Tunis La Manouba Tunisia
21 Koc University Istanbul Sariyer Turkey 34450
22 PNFA Salud Colectiva Instituto de Altos Estudios Dr Arnoldo Gabaldon Maracay Aragua Venezuela 2103

Sponsors and Collaborators

  • University of Chile
  • Columbia University

Investigators

  • Principal Investigator: Rubén Alvarado, PhD, University of Chile [Universidad de Chile]
  • Principal Investigator: Ezra Susser, MD DrPH, Columbia University
  • Principal Investigator: Franco Mascayano, MPH, Columbia Universty

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Rubén Alvarado, PhD, University of Chile
ClinicalTrials.gov Identifier:
NCT04352634
Other Study ID Numbers:
  • HEROES Covid-19
First Posted:
Apr 20, 2020
Last Update Posted:
Apr 1, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Rubén Alvarado, PhD, University of Chile
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 1, 2021