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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04352634
Ethics application status
Date submitted
8/04/2020
Date registered
20/04/2020

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
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

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
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Experiences, fears and concerns about the Covid-19
Timepoint [1] 0 0
Baseline
Secondary outcome [2] 0 0
Experiences, fears and concerns about the Covid-19
Timepoint [2] 0 0
3 months
Secondary outcome [3] 0 0
Experiences, fears and concerns about the Covid-19
Timepoint [3] 0 0
6 months
Secondary outcome [4] 0 0
Experiences, fears and concerns about the Covid-19
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
Training and resource prioritization
Timepoint [5] 0 0
Baseline
Secondary outcome [6] 0 0
Training and resource prioritization
Timepoint [6] 0 0
3 months
Secondary outcome [7] 0 0
Training and resource prioritization
Timepoint [7] 0 0
6 months
Secondary outcome [8] 0 0
Training and resource prioritization
Timepoint [8] 0 0
12 months
Secondary outcome [9] 0 0
Suicide ideation (presence)
Timepoint [9] 0 0
Baseline
Secondary outcome [10] 0 0
Suicide ideation (presence)
Timepoint [10] 0 0
3 months
Secondary outcome [11] 0 0
Suicide ideation (presence)
Timepoint [11] 0 0
6 months
Secondary outcome [12] 0 0
Suicide ideation (presence)
Timepoint [12] 0 0
12 months
Secondary outcome [13] 0 0
Suicide ideation (frequency)
Timepoint [13] 0 0
Baseline
Secondary outcome [14] 0 0
Suicide ideation (frequency)
Timepoint [14] 0 0
3 months
Secondary outcome [15] 0 0
Suicide ideation (frequency)
Timepoint [15] 0 0
6 months
Secondary outcome [16] 0 0
Suicide ideation (frequency)
Timepoint [16] 0 0
12 months
Secondary outcome [17] 0 0
Acute stress symptoms
Timepoint [17] 0 0
Baseline
Secondary outcome [18] 0 0
Acute stress symptoms
Timepoint [18] 0 0
3 months
Secondary outcome [19] 0 0
Acute stress symptoms
Timepoint [19] 0 0
6 months
Secondary outcome [20] 0 0
Acute stress symptoms
Timepoint [20] 0 0
12 months
Secondary outcome [21] 0 0
Psycho/social support and network
Timepoint [21] 0 0
Baseline
Secondary outcome [22] 0 0
Psycho/social support and network
Timepoint [22] 0 0
3 months
Secondary outcome [23] 0 0
Psycho/social support and network
Timepoint [23] 0 0
6 months
Secondary outcome [24] 0 0
Psycho/social support and network
Timepoint [24] 0 0
12 months
Secondary outcome [25] 0 0
Resilience
Timepoint [25] 0 0
Baseline
Secondary outcome [26] 0 0
Resilience
Timepoint [26] 0 0
3 months
Secondary outcome [27] 0 0
Resilience
Timepoint [27] 0 0
6 months
Secondary outcome [28] 0 0
Resilience
Timepoint [28] 0 0
12 months
Secondary outcome [29] 0 0
Anxiety and depressive symptoms
Timepoint [29] 0 0
Baseline
Secondary outcome [30] 0 0
Anxiety and depressive symptoms
Timepoint [30] 0 0
3 months
Secondary outcome [31] 0 0
Anxiety and depressive symptoms
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
Sex
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
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/04/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
2000
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
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Columbia University
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04352634