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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04352634




Registration number
NCT04352634
Ethics application status
Date submitted
8/04/2020
Date registered
20/04/2020
Date last updated
14/07/2020

Titles & IDs
Public title
The Covid-19 HEalth caRe wOrkErS (HEROES) Study
Scientific 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
Secondary ID [1] 0 0
HEROES Covid-19
Universal Trial Number (UTN)
Trial acronym
HEROES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Covid-19 0 0
Mental Health Disorder 0 0
Stress Disorder 0 0
Anxiety 0 0
Depression 0 0
SARS-CoV-2 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Exposure to the SARS-CoV-2 and its consequences

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 interventions: 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 code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Anxiety and depressive symptoms - 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
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Experiences, fears and concerns about the Covid-19 - Ad hoc survey on experiences, fears, and concerns about Covid-19
Timepoint [1] 0 0
Baseline
Secondary outcome [2] 0 0
Experiences, fears and concerns about the Covid-19 - Ad hoc survey on experiences, fears, and concerns about Covid-19
Timepoint [2] 0 0
3 months
Secondary outcome [3] 0 0
Experiences, fears and concerns about the Covid-19 - Ad hoc survey on experiences, fears, and concerns about Covid-19
Timepoint [3] 0 0
6 months
Secondary outcome [4] 0 0
Experiences, fears and concerns about the Covid-19 - Ad hoc survey on experiences, fears, and concerns about Covid-19
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
Training and resource prioritization - Ad hoc survey on Covid-19 training and resource prioritization
Timepoint [5] 0 0
Baseline
Secondary outcome [6] 0 0
Training and resource prioritization - Ad hoc survey on Covid-19 training and resource prioritization
Timepoint [6] 0 0
3 months
Secondary outcome [7] 0 0
Training and resource prioritization - Ad hoc survey on Covid-19 training and resource prioritization
Timepoint [7] 0 0
6 months
Secondary outcome [8] 0 0
Training and resource prioritization - Ad hoc survey on Covid-19 training and resource prioritization
Timepoint [8] 0 0
12 months
Secondary outcome [9] 0 0
Suicide ideation (presence) - Item from the Columbia Suicide Severity Rating Scale (C-SSRS) that measures suicidal ideation with a dichotomous answer (presence/absence)
Timepoint [9] 0 0
Baseline
Secondary outcome [10] 0 0
Suicide ideation (presence) - Item from the Columbia Suicide Severity Rating Scale (C-SSRS) that measures suicidal ideation with a dichotomous answer (presence/absence)
Timepoint [10] 0 0
3 months
Secondary outcome [11] 0 0
Suicide ideation (presence) - Item from the Columbia Suicide Severity Rating Scale (C-SSRS) that measures suicidal ideation with a dichotomous answer (presence/absence)
Timepoint [11] 0 0
6 months
Secondary outcome [12] 0 0
Suicide ideation (presence) - Item from the Columbia Suicide Severity Rating Scale (C-SSRS) that measures suicidal ideation with a dichotomous answer (presence/absence)
Timepoint [12] 0 0
12 months
Secondary outcome [13] 0 0
Suicide ideation (frequency) - 5-point Likert item from the Columbia Suicide Severity Rating Scale (C-SSRS). Higher scores indicate higher frequency.
Timepoint [13] 0 0
Baseline
Secondary outcome [14] 0 0
Suicide ideation (frequency) - 5-point Likert item from the Columbia Suicide Severity Rating Scale (C-SSRS). Higher scores indicate higher frequency.
Timepoint [14] 0 0
3 months
Secondary outcome [15] 0 0
Suicide ideation (frequency) - 5-point Likert item from the Columbia Suicide Severity Rating Scale (C-SSRS). Higher scores indicate higher frequency.
Timepoint [15] 0 0
6 months
Secondary outcome [16] 0 0
Suicide ideation (frequency) - 5-point Likert item from the Columbia Suicide Severity Rating Scale (C-SSRS). Higher scores indicate higher frequency.
Timepoint [16] 0 0
12 months
Secondary outcome [17] 0 0
Acute stress symptoms - Ad hoc 3-item survey to evaluate acute stress disorder. Higher values of the 5-points Likert scales suggest higher frequency of symptoms
Timepoint [17] 0 0
Baseline
Secondary outcome [18] 0 0
Acute stress symptoms - Ad hoc 3-item survey to evaluate acute stress disorder. Higher values of the 5-points Likert scales suggest higher frequency of symptoms
Timepoint [18] 0 0
3 months
Secondary outcome [19] 0 0
Acute stress symptoms - Ad hoc 3-item survey to evaluate acute stress disorder. Higher values of the 5-points Likert scales suggest higher frequency of symptoms
Timepoint [19] 0 0
6 months
Secondary outcome [20] 0 0
Acute stress symptoms - Ad hoc 3-item survey to evaluate acute stress disorder. Higher values of the 5-points Likert scales suggest higher frequency of symptoms
Timepoint [20] 0 0
12 months
Secondary outcome [21] 0 0
Psycho/social support and network - 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
Timepoint [21] 0 0
Baseline
Secondary outcome [22] 0 0
Psycho/social support and network - 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
Timepoint [22] 0 0
3 months
Secondary outcome [23] 0 0
Psycho/social support and network - 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
Timepoint [23] 0 0
6 months
Secondary outcome [24] 0 0
Psycho/social support and network - 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
Timepoint [24] 0 0
12 months
Secondary outcome [25] 0 0
Resilience - 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.
Timepoint [25] 0 0
Baseline
Secondary outcome [26] 0 0
Resilience - 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.
Timepoint [26] 0 0
3 months
Secondary outcome [27] 0 0
Resilience - 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.
Timepoint [27] 0 0
6 months
Secondary outcome [28] 0 0
Resilience - 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.
Timepoint [28] 0 0
12 months
Secondary outcome [29] 0 0
Anxiety and depressive symptoms - 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
Timepoint [29] 0 0
Baseline
Secondary outcome [30] 0 0
Anxiety and depressive symptoms - 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
Timepoint [30] 0 0
3 months
Secondary outcome [31] 0 0
Anxiety and depressive symptoms - 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
Timepoint [31] 0 0
6 months

Eligibility
Key inclusion criteria
- Legal age

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

- Give informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Inability to use electronic devices (required to complete the survey)

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
University of Sydney - Sidney
Recruitment postcode(s) [1] 0 0
2031 - Sidney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
Argentina
State/province [2] 0 0
Chubut
Country [3] 0 0
Armenia
State/province [3] 0 0
Yerevan
Country [4] 0 0
Bolivia
State/province [4] 0 0
Chuquisaca
Country [5] 0 0
Chile
State/province [5] 0 0
Santiago
Country [6] 0 0
Costa Rica
State/province [6] 0 0
Heredia
Country [7] 0 0
Czechia
State/province [7] 0 0
Bohemia
Country [8] 0 0
Germany
State/province [8] 0 0
Niedersachsen
Country [9] 0 0
Guatemala
State/province [9] 0 0
Guatemala City
Country [10] 0 0
Italy
State/province [10] 0 0
CA
Country [11] 0 0
Italy
State/province [11] 0 0
Cagliari
Country [12] 0 0
Lebanon
State/province [12] 0 0
Beirut
Country [13] 0 0
Mexico
State/province [13] 0 0
Jalisco
Country [14] 0 0
Netherlands
State/province [14] 0 0
Limburg
Country [15] 0 0
Nigeria
State/province [15] 0 0
Oyo State
Country [16] 0 0
Puerto Rico
State/province [16] 0 0
Ponce
Country [17] 0 0
Saudi Arabia
State/province [17] 0 0
Central
Country [18] 0 0
Spain
State/province [18] 0 0
Madrid
Country [19] 0 0
Tunisia
State/province [19] 0 0
La Manouba
Country [20] 0 0
Turkey
State/province [20] 0 0
Sariyer
Country [21] 0 0
Venezuela
State/province [21] 0 0
Aragua

Funding & Sponsors
Primary sponsor type
Other
Name
University of Chile
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT04352634
Trial related presentations / publications
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. Review.
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)
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Rubén Alvarado, PhD
Address 0 0
University of Chile [Universidad de Chile]
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Rubén Alvarado, PhD
Address 0 0
Country 0 0
Phone 0 0
+56 2 2978 6967
Fax 0 0
Email 0 0
ralvarado@med.uchile.cl
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04352634