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The Covid-19 HEalth caRe wOrkErS (HEROES) Study (HEROES)

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: NCT04352634
Recruitment Status : Recruiting
First Posted : April 20, 2020
Last Update Posted : May 21, 2020
Sponsor:
Information provided by (Responsible Party):
Rubén Alvarado, University of Chile

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).

Accordingly, this prospective (0, 3, 6 and 12 months), multisite cohort study aims to describe, examine, and evaluate the impact of the Covid-19 pandemic on mental health and social factors among workers at health services from Latin America and the Caribbean, Europe and neighboring countries, the Middle East and North Africa, as well as Sub-Saharan Africa and Asia. Additionally, a team from the United States of America will also participate in this collaborative effort providing expertise on psychiatric epidemiology and supporting coordination across countries.


Condition or disease Intervention/treatment
Covid-19 Mental Health Disorder Stress Disorder Anxiety Depression SARS-CoV-2 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.

Accordingly, this prospective (0, 3, 6 and 12 months), multisite cohort study aims to describe, examine, and evaluate the impact of the Covid-19 pandemic on mental health and psycho/social factors among workers at health services from Latin America and the Caribbean (Chile, Argentina, Ecuador, Peru, Colombia, Guatemala, Mexico, Bolivia, and Puerto Rico), Europe and neighboring countries (Spain, Italy, the Netherlands, Germany, Armenia, Poland, Macedonia, and Turkey), the Middle East and North Africa (Lebanon and Tunisia), as well as Sub-Saharan Africa (Nigeria, Ghana) and Asia (China). Additionally, a team from the United States of America will also participate in this collaborative effort providing expertise on psychiatric epidemiology and supporting coordination across countries.

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).

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Study Type : Observational
Estimated 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 : April 26, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort 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




Primary Outcome Measures :
  1. Anxiety and depressive symptoms [ Time Frame: 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 [ Time Frame: Baseline ]
    Ad hoc survey on experiences, fears, and concerns about Covid-19

  2. Experiences, fears and concerns about the Covid-19 [ Time Frame: 3 months ]
    Ad hoc survey on experiences, fears, and concerns about Covid-19

  3. Experiences, fears and concerns about the Covid-19 [ Time Frame: 6 months ]
    Ad hoc survey on experiences, fears, and concerns about Covid-19

  4. Experiences, fears and concerns about the Covid-19 [ Time Frame: 12 months ]
    Ad hoc survey on experiences, fears, and concerns about Covid-19

  5. Training and resource prioritization [ Time Frame: Baseline ]
    Ad hoc survey on Covid-19 training and resource prioritization

  6. Training and resource prioritization [ Time Frame: 3 months ]
    Ad hoc survey on Covid-19 training and resource prioritization

  7. Training and resource prioritization [ Time Frame: 6 months ]
    Ad hoc survey on Covid-19 training and resource prioritization

  8. Training and resource prioritization [ Time Frame: 12 months ]
    Ad hoc survey on Covid-19 training and resource prioritization

  9. Suicide ideation (presence) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Baseline ]
    5-point Likert item from the Columbia Suicide Severity Rating Scale (C-SSRS). Higher scores indicate higher frequency.

  14. Suicide ideation (frequency) [ Time Frame: 3 months ]
    5-point Likert item from the Columbia Suicide Severity Rating Scale (C-SSRS). Higher scores indicate higher frequency.

  15. Suicide ideation (frequency) [ Time Frame: 6 months ]
    5-point Likert item from the Columbia Suicide Severity Rating Scale (C-SSRS). Higher scores indicate higher frequency.

  16. Suicide ideation (frequency) [ Time Frame: 12 months ]
    5-point Likert item from the Columbia Suicide Severity Rating Scale (C-SSRS). Higher scores indicate higher frequency.

  17. Acute stress symptoms [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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



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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This study will include 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)
Criteria

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)

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): NCT04352634


Contacts
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Contact: Rubén Alvarado, PhD +56 2 2978 6967 ralvarado@med.uchile.cl

Locations
Show Show 21 study locations
Sponsors and Collaborators
University of Chile
Investigators
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Study Chair: Rubén Alvarado, PhD University of Chile [Universidad de Chile]

Publications:
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Responsible Party: Rubén Alvarado, PhD, University of Chile
ClinicalTrials.gov Identifier: NCT04352634    
Other Study ID Numbers: HEROES Covid-19
First Posted: April 20, 2020    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rubén Alvarado, University of Chile:
Covid-19
healthcare professionals
mental health
pandemic
Additional relevant MeSH terms:
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Disease
Mental Disorders
Pathologic Processes