Clinical trial NCT04352634: The Covid-19 HEalth caRe wOrkErS (HEROES) Study
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid-19
Mental Health Disorder
Stress Disorder
Anxiety
Depression
SARS-CoV-2
Keywords: Covid-19
healthcare professionals
mental health
pandemic
Lead sponsor: University of Chile
Sponsor class: OTHER
Collaborators: name: Columbia University
First posted: 2020-04-20
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.

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).

Eligibility 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)

Primary outcomes:
measure: Anxiety and depressive symptoms
timeFrame: 12 months
Secondary outcomes:
measure: Experiences, fears and concerns about the Covid-19
timeFrame: Baseline
measure: Experiences, fears and concerns about the Covid-19
timeFrame: 3 months
measure: Experiences, fears and concerns about the Covid-19
timeFrame: 6 months
measure: Experiences, fears and concerns about the Covid-19
timeFrame: 12 months
measure: Training and resource prioritization
timeFrame: Baseline
measure: Training and resource prioritization
timeFrame: 3 months
measure: Training and resource prioritization
timeFrame: 6 months
measure: Training and resource prioritization
timeFrame: 12 months
measure: Suicide ideation (presence)
timeFrame: Baseline
measure: Suicide ideation (presence)
timeFrame: 3 months
measure: Suicide ideation (presence)
timeFrame: 6 months
measure: Suicide ideation (presence)
timeFrame: 12 months
measure: Suicide ideation (frequency)
timeFrame: Baseline
measure: Suicide ideation (frequency)
timeFrame: 3 months
measure: Suicide ideation (frequency)
timeFrame: 6 months
measure: Suicide ideation (frequency)
timeFrame: 12 months
measure: Acute stress symptoms
timeFrame: Baseline
measure: Acute stress symptoms
timeFrame: 3 months
measure: Acute stress symptoms
timeFrame: 6 months
measure: Acute stress symptoms
timeFrame: 12 months
measure: Psycho/social support and network
timeFrame: Baseline
measure: Psycho/social support and network
timeFrame: 3 months
measure: Psycho/social support and network
timeFrame: 6 months
measure: Psycho/social support and network
timeFrame: 12 months
measure: Resilience
timeFrame: Baseline
measure: Resilience
timeFrame: 3 months
measure: Resilience
timeFrame: 6 months
measure: Resilience
timeFrame: 12 months
measure: Anxiety and depressive symptoms
timeFrame: Baseline
measure: Anxiety and depressive symptoms
timeFrame: 3 months
measure: Anxiety and depressive symptoms
timeFrame: 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
city: Rawson
country: Argentina
facility: Universidad del Chubut
state: Chubut
city: Yerevan
country: Armenia
facility: National Institute of Health Named After Academician S. Avdalbekyan
city: Sidney
country: Australia
facility: University of Sydney
state: New South Wales
city: Sucre
country: Bolivia
facility: Salud Global
state: Chuquisaca
city: Santiago
country: Chile
facility: University of Chile
city: Heredia
country: Costa Rica
facility: Universidad Nacional de Costa Rica
city: Kladno
country: Czechia
facility: Society for Emergecy and Disaster Medicine CzMA JEP
state: Bohemia
city: Emden
country: Germany
facility: Hochschule Emden/Leer
state: Niedersachsen
city: Guatemala City
country: Guatemala
facility: Centro de Investigaciones de las Ciencias de la Salud -CICS- Facultad de Ciencias Médicas Universidad de San Carlos de Guatemala -USAC-
city: Cagliari
country: Italy
facility: University of Cagliari
state: CA
city: Cagliari
country: Italy
facility: University of Cagliari
city: Beirut
country: Lebanon
facility: The Institute for Development Research Advocacy and Applied Care (IDRAAC)
city: Guadalajara
country: Mexico
facility: Logotipo del comercio Instituto Jalisciense De Salud Mental (SALME)
state: Jalisco
city: Maastricht
country: Netherlands
facility: Maastricht University
state: Limburg
city: Ibadan
country: Nigeria
facility: University of Ibadan
state: Oyo State
city: Ponce
country: Puerto Rico
facility: Ponce Health Sciences University
city: Riyadh
country: Saudi Arabia
facility: King Abdullah International medical research center
state: Central
city: Madrid
country: Spain
facility: Hospital La Paz Institute for Health Research (IdiPAZ)
city: Tunis
country: Tunisia
facility: Razi Hospital La Manouba
state: La Manouba
city: Istanbul
country: Turkey
facility: Koc University
state: Sariyer
city: Maracay
country: Venezuela
facility: PNFA Salud Colectiva Instituto de Altos Estudios Dr Arnoldo Gabaldon
state: Aragua
Study officials:
affiliation: University of Chile [Universidad de Chile]
name: Rubén Alvarado, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Ezra Susser, MD DrPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia Universty
name: Franco Mascayano, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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)
citation: 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.
citation: 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.