The Covid-19 HEalth caRe wOrkErS (HEROES) Study

NCT ID: NCT04352634

Last Updated: 2021-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-26

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Covid-19 Mental Health Disorder Stress Disorder Anxiety Depression SARS-CoV-2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

Exposure to the SARS-CoV-2 and its consequences

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Columbia University

OTHER

Sponsor Role collaborator

University of Chile

OTHER

Sponsor Role lead

Responsible Party

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Rubén Alvarado

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rubén Alvarado, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Chile [Universidad de Chile]

Ezra Susser, MD DrPH

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Franco Mascayano, MPH

Role: PRINCIPAL_INVESTIGATOR

Columbia Universty

Locations

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Columbia University

New York, New York, United States

Site Status ACTIVE_NOT_RECRUITING

Universidad del Chubut

Rawson, Chubut Province, Argentina

Site Status RECRUITING

National Institute of Health Named After Academician S. Avdalbekyan

Yerevan, , Armenia

Site Status RECRUITING

University of Sydney

Sydney, New South Wales, Australia

Site Status NOT_YET_RECRUITING

Salud Global

Sucre, Chuquisaca Department, Bolivia

Site Status NOT_YET_RECRUITING

University of Chile

Santiago, , Chile

Site Status NOT_YET_RECRUITING

Universidad Nacional de Costa Rica

Heredia, , Costa Rica

Site Status NOT_YET_RECRUITING

Society for Emergecy and Disaster Medicine CzMA JEP

Kladno, Bohemia, Czechia

Site Status RECRUITING

Hochschule Emden/Leer

Emden, Lower Saxony, Germany

Site Status RECRUITING

Centro de Investigaciones de las Ciencias de la Salud -CICS- Facultad de Ciencias Médicas Universidad de San Carlos de Guatemala -USAC-

Guatemala City, , Guatemala

Site Status RECRUITING

University of Cagliari

Cagliari, CA, Italy

Site Status RECRUITING

University of Cagliari

Cagliari, , Italy

Site Status NOT_YET_RECRUITING

The Institute for Development Research Advocacy and Applied Care (IDRAAC)

Beirut, , Lebanon

Site Status NOT_YET_RECRUITING

Logotipo del comercio Instituto Jalisciense De Salud Mental (SALME)

Guadalajara, Jalisco, Mexico

Site Status RECRUITING

Maastricht University

Maastricht, Limburg, Netherlands

Site Status NOT_YET_RECRUITING

University of Ibadan

Ibadan, Oyo State, Nigeria

Site Status NOT_YET_RECRUITING

Ponce Health Sciences University

Ponce, , Puerto Rico

Site Status RECRUITING

King Abdullah International medical research center

Riyadh, Central, Saudi Arabia

Site Status NOT_YET_RECRUITING

Hospital La Paz Institute for Health Research (IdiPAZ)

Madrid, , Spain

Site Status RECRUITING

Razi Hospital La Manouba

Tunis, La Manouba, Tunisia

Site Status RECRUITING

Koc University

Istanbul, Sariyer, Turkey (Türkiye)

Site Status ACTIVE_NOT_RECRUITING

PNFA Salud Colectiva Instituto de Altos Estudios Dr Arnoldo Gabaldon

Maracay, Aragua, Venezuela

Site Status RECRUITING

Countries

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United States Argentina Armenia Australia Bolivia Chile Costa Rica Czechia Germany Guatemala Italy Lebanon Mexico Netherlands Nigeria Puerto Rico Saudi Arabia Spain Tunisia Turkey (Türkiye) Venezuela

Central Contacts

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Rubén Alvarado, PhD

Role: CONTACT

+56 2 2978 6967

Facility Contacts

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Marcela Inés Freytes Frey, PhD

Role: primary

5492804263454

Rodrigo Ezequiel Jaldo, BsC

Role: backup

5493513908707

Anna Isahakyan, MD

Role: primary

+37499990074

Clare A McCormack, PhD

Role: primary

3477129331

Sonja Memedovic, PhD

Role: backup

María Teresa Solís Soto, MD, PhD

Role: primary

59173295148

Armando Basagoitia Echalar, MD, MsC

Role: backup

59170324803

Rubén Alvarado, PhD

Role: primary

+56 2 2978 6967

Iliana Araya Ramírez, MD, PhD

Role: primary

50683897058

María Chaves Villalobos, MsC

Role: backup

50688865120

Jana Seblova, MD, PhD

Role: primary

00420724568877

Jutta Lindert, MD, PhD

Role: primary

00491774158919

Marta Natan

Role: backup

Dorian E Ramírez Flores, MD, MsC

Role: primary

50224187459

Víctor Puac-Polanco, MD, MsC

Role: backup

50224187459

Maria Francesca Moro, MD

Role: primary

+390706093498

Mauro Giovanni Carta, MD

Role: backup

+390706093498

Francesca Moro, MD

Role: primary

Elie Karam, MD

Role: primary

9611583583

Georges Karam, MD

Role: backup

9611583583

Jaime Carmona Huerta, MD, PhD

Role: primary

3322562339

Allen Akcel Rodríguez, BsC

Role: backup

3313585332

Els van der Ven, PhD

Role: primary

+17185367406

Oye Gureje, MD, PhD

Role: primary

+2348033464284

Olatunde Ayinde, MD, MsC

Role: backup

+2348032107441

Eliut Rivera-Segarra, PhD

Role: primary

7874596312

Lubna Alnasser, MsC

Role: primary

00966504468135

Sulainam Alghnam, PhD

Role: backup

00966539468887

Roberto Mediavilla, PhD

Role: primary

+347270000

Eduardo Fernández-Jiménez, PhD

Role: backup

+347270000

Uta Ouali, MD

Role: primary

+21623266078

Fethi Nacef, MD

Role: backup

+21698302065

Ana Maria Rodrigues Rodrigues, MsC

Role: primary

+5804264325417

Juan Quintana, MsC

Role: backup

+5804166467999

References

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Brooks SK, Webster RK, Smith LE, Woodland L, Wessely S, Greenberg N, Rubin GJ. The psychological impact of quarantine and how to reduce it: rapid review of the evidence. Lancet. 2020 Mar 14;395(10227):912-920. doi: 10.1016/S0140-6736(20)30460-8. Epub 2020 Feb 26.

Reference Type BACKGROUND
PMID: 32112714 (View on PubMed)

Nacoti M, et al. At the Epicenter of the Covid-19 Pandemic and Humanitarian Crises in Italy: Changing Perspectives on Preparation and Mitigation. NEJM Catalyst, 2020;1(2)

Reference Type BACKGROUND

Huang L, Lei W, Xu F, Liu H, Yu L. Emotional responses and coping strategies in nurses and nursing students during Covid-19 outbreak: A comparative study. PLoS One. 2020 Aug 7;15(8):e0237303. doi: 10.1371/journal.pone.0237303. eCollection 2020.

Reference Type BACKGROUND
PMID: 32764825 (View on PubMed)

Lai J, Ma S, Wang Y, Cai Z, Hu J, Wei N, Wu J, Du H, Chen T, Li R, Tan H, Kang L, Yao L, Huang M, Wang H, Wang G, Liu Z, Hu S. Factors Associated With Mental Health Outcomes Among Health Care Workers Exposed to Coronavirus Disease 2019. JAMA Netw Open. 2020 Mar 2;3(3):e203976. doi: 10.1001/jamanetworkopen.2020.3976.

Reference Type BACKGROUND
PMID: 32202646 (View on PubMed)

Asaoka H, Watanabe K, Miyamoto Y, Restrepo-Henao A, van der Ven E, Moro MF, Alnasser LA, Ayinde O, Balalian AA, Basagoitia A, Durand-Arias S, Eskin M, Fernandez-Jimenez E, Ines FFM, Gimenez L, Hoek HW, Jaldo RE, Lindert J, Maldonado H, Martinez-Ales G, Mediavilla R, McCormack C, Narvaez J, Ouali U, Barrera-Perez A, Calgua-Guerra E, Ramirez J, Rodriguez AM, Seblova D, da Silva ATC, Valeri L, Gureje O, Ballester D, Carta MG, Isahakyan A, Jamoussi A, Seblova J, Solis-Soto MT, Alvarado R, Susser E, Mascayano F, Nishi D; HEROES group. Association of depressive symptoms with incidence and mortality rates of COVID-19 over 2 years among healthcare workers in 20 countries: multi-country serial cross-sectional study. BMC Med. 2024 Sep 12;22(1):386. doi: 10.1186/s12916-024-03585-8.

Reference Type DERIVED
PMID: 39267052 (View on PubMed)

Other Identifiers

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HEROES Covid-19

Identifier Type: -

Identifier Source: org_study_id

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