NCT04486404

Brief Summary

The pressure on care and the demand for critical decision-making generated by the current SARS-CoV-2 (COVID-19) pandemic, together with the situation of extreme social alarm and the adverse conditions in which care work must be promoted at this time, draw an extreme scenario in which action is urgently needed to alleviate emotional overload, acute stress reactions and other affective pathologies or psychosomatic reactions that may eventually lead to post-traumatic stress situations. This eventuality is being observed massively among professionals from different groups and levels of responsibility. In the case of healthcare personnel, it should be added that the care of non-COVID19 patients (of all pathologies and conditions) is clearly compromised and it is up to the professionals as a whole to make critical decisions and exercise a professional practice that is radically different from what has usually been done, which may require the application of undesirable triage criteria that are difficult for everyone to assume. Healthcare professionals and other essential personnel for healthcare and social-healthcare work (including personnel from external companies) are being subjected to emotional tensions and extraordinary, high-intensity work demands. Without professionals who feel supported and with moral strength, care will be even more compromised. The current scenario makes us think of many critical situations that are occurring as a result of the overload experienced. It is essential to act in order to counteract the devastating effect of this health crisis on health professionals and those who support them in their care work.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Geographic Reach
5 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 24, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

September 19, 2022

Status Verified

September 1, 2022

Enrollment Period

9 months

First QC Date

July 23, 2020

Last Update Submit

September 16, 2022

Conditions

Keywords

COVID-19Healthcare PersonnelMental HealthAcute stressHospitalsPrimary care

Outcome Measures

Primary Outcomes (1)

  • Prevalence of Acute Stress

    Prevalence of acute stress using the Acute Stress Scale (EASE Scale) among healthcare personnel in the front-line caring for COVID-19 patients. Score values range from 0 to 30. 0-9 points, good emotional adjustment; 10-14 points, emotional distress; 15-24 points, medium-high emotional overload; \> 25 points, extreme acute stress.

    15 days

Study Arms (2)

Group 1

Online survery to healtcare personnel and other professionals in the front-line from Col, Bra and Ec.

Other: Online survey

Group 2

Online survery to healtcare personnel and other professionals in the front-line from Col, Bra, Ch and Ec.

Other: Online survey

Interventions

Online survey including questions related to PPE availability, perceptions, emotions and EASE scale (Acute Stress Scale).

Group 1Group 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthcare personnel in the front line of exposure to suspicious and confirmed cases of COVID-19 and healthcare support personnel (administrative assistants, cleaning or security personnel) of these services and units, such as Emergency and Primary Health Care Services, Internal Medicine, Critical Care and Resuscitation, Intermediate Care and any other area designated for the care of such cases.

You may qualify if:

  • Healthcare professionals, other professionals working in the front-line of COVID-19.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Institute for Clinical Effectiveness and Health Policy

Buenos Aires, Argentina

Location

Pontificia Universidad Católica de Chile

Santiago, Chile

Location

Universidad de Santander

Bucaramanga, Santander Department, Colombia

Location

Universidad Católica de Santiago de Guayaquil

Guayaquil, Guayas, Ecuador

Location

Universidad Miguel Hernández de Elche

Elche, Alicante, 03202, Spain

Location

Related Publications (14)

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    PMID: 29887301BACKGROUND
  • Chen Q, Liang M, Li Y, Guo J, Fei D, Wang L, He L, Sheng C, Cai Y, Li X, Wang J, Zhang Z. Mental health care for medical staff in China during the COVID-19 outbreak. Lancet Psychiatry. 2020 Apr;7(4):e15-e16. doi: 10.1016/S2215-0366(20)30078-X. Epub 2020 Feb 19. No abstract available.

    PMID: 32085839BACKGROUND
  • Everly GS Jr, Mitchell JT. The debriefing "controversy" and crisis intervention: a review of lexical and substantive issues. Int J Emerg Ment Health. 2000 Fall;2(4):211-25.

    PMID: 11217152BACKGROUND
  • Kang L, Li Y, Hu S, Chen M, Yang C, Yang BX, Wang Y, Hu J, Lai J, Ma X, Chen J, Guan L, Wang G, Ma H, Liu Z. The mental health of medical workers in Wuhan, China dealing with the 2019 novel coronavirus. Lancet Psychiatry. 2020 Mar;7(3):e14. doi: 10.1016/S2215-0366(20)30047-X. Epub 2020 Feb 5. No abstract available.

    PMID: 32035030BACKGROUND
  • Khalid I, Khalid TJ, Qabajah MR, Barnard AG, Qushmaq IA. Healthcare Workers Emotions, Perceived Stressors and Coping Strategies During a MERS-CoV Outbreak. Clin Med Res. 2016 Mar;14(1):7-14. doi: 10.3121/cmr.2016.1303. Epub 2016 Feb 4.

    PMID: 26847480BACKGROUND
  • Li W, Yang Y, Liu ZH, Zhao YJ, Zhang Q, Zhang L, Cheung T, Xiang YT. Progression of Mental Health Services during the COVID-19 Outbreak in China. Int J Biol Sci. 2020 Mar 15;16(10):1732-1738. doi: 10.7150/ijbs.45120. eCollection 2020.

    PMID: 32226291BACKGROUND
  • Mira JJ, Carrillo I, Guilabert M, Lorenzo S, Perez-Perez P, Silvestre C, Ferrus L; Spanish Second Victim Research Team. The Second Victim Phenomenon After a Clinical Error: The Design and Evaluation of a Website to Reduce Caregivers' Emotional Responses After a Clinical Error. J Med Internet Res. 2017 Jun 8;19(6):e203. doi: 10.2196/jmir.7840.

    PMID: 28596148BACKGROUND
  • Mira JJ, Carrillo I, Lorenzo S, Ferrus L, Silvestre C, Perez-Perez P, Olivera G, Iglesias F, Zavala E, Maderuelo-Fernandez JA, Vitaller J, Nuno-Solinis R, Astier P; Research Group on Second and Third Victims. The aftermath of adverse events in Spanish primary care and hospital health professionals. BMC Health Serv Res. 2015 Apr 9;15:151. doi: 10.1186/s12913-015-0790-7.

    PMID: 25886369BACKGROUND
  • Mitchell JT. Innovative, precise, and descriptive terms for group crisis support services: a United Nations initiative. Int J Emerg Ment Health. 2007 Fall;9(4):247-52.

    PMID: 18459528BACKGROUND
  • Scott SD, Hirschinger LE, Cox KR, McCoig M, Hahn-Cover K, Epperly KM, Phillips EC, Hall LW. Caring for our own: deploying a systemwide second victim rapid response team. Jt Comm J Qual Patient Saf. 2010 May;36(5):233-40. doi: 10.1016/s1553-7250(10)36038-7.

    PMID: 20480757BACKGROUND
  • Wu P, Fang Y, Guan Z, Fan B, Kong J, Yao Z, Liu X, Fuller CJ, Susser E, Lu J, Hoven CW. The psychological impact of the SARS epidemic on hospital employees in China: exposure, risk perception, and altruistic acceptance of risk. Can J Psychiatry. 2009 May;54(5):302-11. doi: 10.1177/070674370905400504.

    PMID: 19497162BACKGROUND
  • Xiang YT, Yang Y, Li W, Zhang L, Zhang Q, Cheung T, Ng CH. Timely mental health care for the 2019 novel coronavirus outbreak is urgently needed. Lancet Psychiatry. 2020 Mar;7(3):228-229. doi: 10.1016/S2215-0366(20)30046-8. Epub 2020 Feb 4. No abstract available.

    PMID: 32032543BACKGROUND
  • Martin-Delgado J, Poblete R, Serpa P, Mula A, Carrillo I, Fernandez C, Vicente Ripoll MA, Loudet C, Jorro F, Garcia Elorrio E, Guilabert M, Mira JJ. Contributing factors for acute stress in healthcare workers caring for COVID-19 patients in Argentina, Chile, Colombia, and Ecuador. Sci Rep. 2022 May 19;12(1):8496. doi: 10.1038/s41598-022-12626-2.

  • Martin-Delgado J, Viteri E, Mula A, Serpa P, Pacheco G, Prada D, Campos de Andrade Lourencao D, Campos Pavan Baptista P, Ramirez G, Mira JJ. Availability of personal protective equipment and diagnostic and treatment facilities for healthcare workers involved in COVID-19 care: A cross-sectional study in Brazil, Colombia, and Ecuador. PLoS One. 2020 Nov 11;15(11):e0242185. doi: 10.1371/journal.pone.0242185. eCollection 2020.

Related Links

MeSH Terms

Conditions

Stress Disorders, Traumatic, AcuteCOVID-19Psychological Well-Being

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPersonal SatisfactionBehavior

Study Officials

  • Jose J Mira, PhD

    Universidad Miguel Hernández de Elche

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 23, 2020

First Posted

July 24, 2020

Study Start

April 1, 2020

Primary Completion

December 30, 2020

Study Completion

December 30, 2021

Last Updated

September 19, 2022

Record last verified: 2022-09

Locations