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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04352634
Registration number
NCT04352634
Ethics application status
Date submitted
8/04/2020
Date registered
20/04/2020
Date last updated
1/04/2021
Titles & IDs
Public title
The Covid-19 HEalth caRe wOrkErS (HEROES) Study
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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
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Secondary ID [1]
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HEROES Covid-19
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Universal Trial Number (UTN)
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Trial acronym
HEROES
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Covid-19
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Mental Health Disorder
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Stress Disorder
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Anxiety
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Depression
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SARS-CoV-2
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Condition category
Condition code
Infection
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Other infectious diseases
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Respiratory
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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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
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Anxiety and depressive symptoms
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Assessment method [1]
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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
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Timepoint [1]
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12 months
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Secondary outcome [1]
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Experiences, fears and concerns about the Covid-19
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Assessment method [1]
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Ad hoc survey on experiences, fears, and concerns about Covid-19
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Timepoint [1]
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Baseline
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Secondary outcome [2]
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Experiences, fears and concerns about the Covid-19
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Assessment method [2]
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Ad hoc survey on experiences, fears, and concerns about Covid-19
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Timepoint [2]
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3 months
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Secondary outcome [3]
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Experiences, fears and concerns about the Covid-19
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Assessment method [3]
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Ad hoc survey on experiences, fears, and concerns about Covid-19
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Timepoint [3]
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6 months
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Secondary outcome [4]
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Experiences, fears and concerns about the Covid-19
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Assessment method [4]
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Ad hoc survey on experiences, fears, and concerns about Covid-19
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Timepoint [4]
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12 months
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Secondary outcome [5]
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Training and resource prioritization
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Assessment method [5]
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Ad hoc survey on Covid-19 training and resource prioritization
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Timepoint [5]
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Baseline
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Secondary outcome [6]
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Training and resource prioritization
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Assessment method [6]
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Ad hoc survey on Covid-19 training and resource prioritization
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Timepoint [6]
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3 months
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Secondary outcome [7]
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Training and resource prioritization
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Assessment method [7]
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Ad hoc survey on Covid-19 training and resource prioritization
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Timepoint [7]
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6 months
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Secondary outcome [8]
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Training and resource prioritization
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Assessment method [8]
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Ad hoc survey on Covid-19 training and resource prioritization
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Timepoint [8]
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12 months
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Secondary outcome [9]
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Suicide ideation (presence)
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Assessment method [9]
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Item from the Columbia Suicide Severity Rating Scale (C-SSRS) that measures suicidal ideation with a dichotomous answer (presence/absence)
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Timepoint [9]
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Baseline
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Secondary outcome [10]
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Suicide ideation (presence)
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Assessment method [10]
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Item from the Columbia Suicide Severity Rating Scale (C-SSRS) that measures suicidal ideation with a dichotomous answer (presence/absence)
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Timepoint [10]
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3 months
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Secondary outcome [11]
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0
Suicide ideation (presence)
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Assessment method [11]
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Item from the Columbia Suicide Severity Rating Scale (C-SSRS) that measures suicidal ideation with a dichotomous answer (presence/absence)
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Timepoint [11]
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6 months
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Secondary outcome [12]
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0
Suicide ideation (presence)
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Assessment method [12]
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0
Item from the Columbia Suicide Severity Rating Scale (C-SSRS) that measures suicidal ideation with a dichotomous answer (presence/absence)
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Timepoint [12]
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12 months
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Secondary outcome [13]
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Suicide ideation (frequency)
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Assessment method [13]
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5-point Likert item from the Columbia Suicide Severity Rating Scale (C-SSRS). Higher scores indicate higher frequency.
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Timepoint [13]
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Baseline
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Secondary outcome [14]
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Suicide ideation (frequency)
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Assessment method [14]
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5-point Likert item from the Columbia Suicide Severity Rating Scale (C-SSRS). Higher scores indicate higher frequency.
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Timepoint [14]
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3 months
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Secondary outcome [15]
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Suicide ideation (frequency)
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Assessment method [15]
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5-point Likert item from the Columbia Suicide Severity Rating Scale (C-SSRS). Higher scores indicate higher frequency.
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Timepoint [15]
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6 months
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Secondary outcome [16]
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Suicide ideation (frequency)
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Assessment method [16]
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5-point Likert item from the Columbia Suicide Severity Rating Scale (C-SSRS). Higher scores indicate higher frequency.
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Timepoint [16]
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12 months
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Secondary outcome [17]
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Acute stress symptoms
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Assessment method [17]
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Ad hoc 3-item survey to evaluate acute stress disorder. Higher values of the 5-points Likert scales suggest higher frequency of symptoms
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Timepoint [17]
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Baseline
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Secondary outcome [18]
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Acute stress symptoms
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Assessment method [18]
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Ad hoc 3-item survey to evaluate acute stress disorder. Higher values of the 5-points Likert scales suggest higher frequency of symptoms
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Timepoint [18]
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3 months
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Secondary outcome [19]
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Acute stress symptoms
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Assessment method [19]
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Ad hoc 3-item survey to evaluate acute stress disorder. Higher values of the 5-points Likert scales suggest higher frequency of symptoms
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Timepoint [19]
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6 months
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Secondary outcome [20]
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Acute stress symptoms
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Assessment method [20]
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Ad hoc 3-item survey to evaluate acute stress disorder. Higher values of the 5-points Likert scales suggest higher frequency of symptoms
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Timepoint [20]
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12 months
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Secondary outcome [21]
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Psycho/social support and network
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Assessment method [21]
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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
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Timepoint [21]
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Baseline
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Secondary outcome [22]
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Psycho/social support and network
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Assessment method [22]
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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
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Timepoint [22]
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3 months
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Secondary outcome [23]
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Psycho/social support and network
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Assessment method [23]
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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
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Timepoint [23]
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6 months
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Secondary outcome [24]
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Psycho/social support and network
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Assessment method [24]
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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
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Timepoint [24]
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12 months
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Secondary outcome [25]
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Resilience
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Assessment method [25]
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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.
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Timepoint [25]
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Baseline
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Secondary outcome [26]
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Resilience
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Assessment method [26]
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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.
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Timepoint [26]
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3 months
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Secondary outcome [27]
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Resilience
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Assessment method [27]
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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.
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Timepoint [27]
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6 months
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Secondary outcome [28]
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Resilience
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Assessment method [28]
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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.
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Timepoint [28]
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12 months
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Secondary outcome [29]
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Anxiety and depressive symptoms
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Assessment method [29]
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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
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Timepoint [29]
0
0
Baseline
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Secondary outcome [30]
0
0
Anxiety and depressive symptoms
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Assessment method [30]
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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
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Timepoint [30]
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3 months
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Secondary outcome [31]
0
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Anxiety and depressive symptoms
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Assessment method [31]
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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
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Timepoint [31]
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6 months
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Eligibility
Key inclusion criteria
- Legal age
- Currently working on a health service that provides care to COVID-19 patients
- Give informed consent
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- Inability to use electronic devices (required to complete the survey)
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/04/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2021
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Actual
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Sample size
Target
2000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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University of Sydney - Sidney
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Recruitment postcode(s) [1]
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2031 - Sidney
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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New York
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Country [2]
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Argentina
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State/province [2]
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Chubut
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Country [3]
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Armenia
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State/province [3]
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Yerevan
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Country [4]
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Bolivia
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State/province [4]
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Chuquisaca
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Country [5]
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Chile
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State/province [5]
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Santiago
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Country [6]
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Costa Rica
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State/province [6]
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Heredia
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Country [7]
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Czechia
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State/province [7]
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Bohemia
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Country [8]
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Germany
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State/province [8]
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Niedersachsen
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Country [9]
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Guatemala
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State/province [9]
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Guatemala City
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Country [10]
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Italy
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State/province [10]
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CA
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Country [11]
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Italy
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State/province [11]
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Cagliari
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Country [12]
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Lebanon
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State/province [12]
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Beirut
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Country [13]
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Mexico
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State/province [13]
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Jalisco
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Country [14]
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Netherlands
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State/province [14]
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Limburg
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Country [15]
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Nigeria
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State/province [15]
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Oyo State
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Country [16]
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Puerto Rico
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State/province [16]
0
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Ponce
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Country [17]
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Saudi Arabia
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State/province [17]
0
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Central
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Country [18]
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Spain
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State/province [18]
0
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Madrid
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Country [19]
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Tunisia
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State/province [19]
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La Manouba
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Country [20]
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Turkey
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State/province [20]
0
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Sariyer
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Country [21]
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Venezuela
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State/province [21]
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Aragua
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Chile
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Columbia University
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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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).
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04352634
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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.
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.
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Public notes
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Contacts
Principal investigator
Name
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Rubén Alvarado, PhD
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Address
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University of Chile [Universidad de Chile]
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Rubén Alvarado, PhD
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Address
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Country
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Phone
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+56 2 2978 6967
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04352634
Download to PDF