NCT05198414

Brief Summary

The SARS-CoV-2 pandemic has particularly impacted Ecuador. By May 31, 2021, 426,000 cases (10% of health professionals) and 20,572 deaths. Care procedures, organization and priorities have been altered, if not broken. The quality and safety of COVID19 and non-COVID19 patients have been compromised. Compassion fatigue, post-traumatic stress and moral damage reactions have been observed among healthcare professionals, considered second victims of SARS-CoV-2. Without professionals who feel supported and morally strong, care will be compromised, leading to greater uncertainty and insecurity in the care of COVID19 and non-COVID19 patients. In coordination with local authorities, this project seeks to strengthen the resilience of public institutions and healthcare professionals to implement. In coordination with local authorities, this project seeks to strengthen the resilience of public institutions and health professionals to implement proven interventions and scale them up to the whole health system to strengthen it after the impact of the COVID19 pandemic. This proposal is aligned with Sustainable Development Goal 3, which includes different targets to ensure healthy lives and promote well-being for all ages. Health emergencies, such as the one resulting from COVID-19, pose a global risk and have shown that preparedness is vital. Improving the Quality of the National Health Services and strengthening the health system in preparedness and response to health emergencies are the main priority lines of action in this project, thus aligning with SDG target 3.8 concerning strengthening health professional morale since to save lives, countries' public health systems must be strengthened. Previous work with the local partner supports the good performance and development of this proposal, which arose from a need based on the need to This proposal arose from a need based on the lessons learned in Spain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

2 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

September 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

September 19, 2022

Status Verified

September 1, 2022

Enrollment Period

5 months

First QC Date

January 17, 2022

Last Update Submit

September 16, 2022

Conditions

Keywords

Healthcare workersQualitative studyCOVID-19Quality of careOccupational StressStress, Physiological

Outcome Measures

Primary Outcomes (1)

  • Recommendations to support and increase the resilience of healthcare workers

    Recommendations to support Ecuador's health system in the COVID-19 pandemic and increase the resilience of personnel in future health emergencies.

    31/05/2022

Other Outcomes (1)

  • Categories of analysis

    01/02/2022

Study Arms (1)

Healthcare workers

Healthcare workers at the first line and healthcare directives.

Other: Focus group

Interventions

Qualitative research methodology with healthcare workers

Healthcare workers

Eligibility Criteria

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

Health professionals of primary care, hospital, medical directors and administrative personnel of the city of Guayaquil who have been working directly with COVID patients or in facilities destined to the care of COVID patients.

You may qualify if:

  • Healthcare workers of primary care providng care to COVID-19 patients.
  • Healthcare workers of hospitals providng care to COVID-19 patients.
  • Medical directors (high management) of COVID-19 hospitals.
  • Administrative personnel of COVID-19 hospitals.

You may not qualify if:

  • \- Healthcare workers, medical directors and administrative personnel not involved in COVID19 care.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital General Norte "Los Ceibos"

Guayaquil, Guayas, Ecuador

Location

Universidad Católica de Santiago de Guayaquil

Guayaquil, Guayas, Ecuador

Location

Related Publications (4)

  • Mira JJ, Carrillo I, Guilabert M, Mula A, Martin-Delgado J, Perez-Jover MV, Vicente MA, Fernandez C; SARS-CoV-2 Second Victim Study Group. Acute stress of the healthcare workforce during the COVID-19 pandemic evolution: a cross-sectional study in Spain. BMJ Open. 2020 Nov 6;10(11):e042555. doi: 10.1136/bmjopen-2020-042555.

    PMID: 33158839BACKGROUND
  • 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.

    PMID: 33175877BACKGROUND
  • Mira JJ, Vicente MA, Lopez-Pineda A, Carrillo I, Guilabert M, Fernandez C, Perez-Jover V, Martin Delgado J, Perez-Perez P, Cobos Vargas A, Astier-Pena MP, Martinez-Garcia OB, Marco-Gomez B, Abad Bouzan C. Preventing and Addressing the Stress Reactions of Health Care Workers Caring for Patients With COVID-19: Development of a Digital Platform (Be + Against COVID). JMIR Mhealth Uhealth. 2020 Oct 5;8(10):e21692. doi: 10.2196/21692.

  • Mira JJ, Cobos-Vargas A, Astier-Pena MP, Perez-Perez P, Carrillo I, Guilabert M, Perez-Jover V, Fernandez-Peris C, Vicente-Ripoll MA, Silvestre-Busto C, Lorenzo-Martinez S, Martin-Delgado J, Aibar C, Aranaz J. Addressing Acute Stress among Professionals Caring for COVID-19 Patients: Lessons Learned during the First Outbreak in Spain (March-April 2020). Int J Environ Res Public Health. 2021 Nov 16;18(22):12010. doi: 10.3390/ijerph182212010.

Related Links

MeSH Terms

Conditions

Occupational StressCOVID-19

Interventions

Focus Groups

Condition Hierarchy (Ancestors)

Occupational DiseasesStress, PsychologicalBehavioral SymptomsBehaviorPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Jose J Mira Solves, PhD

    Universidad Miguel Hernandez

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 17, 2022

First Posted

January 20, 2022

Study Start

September 1, 2021

Primary Completion

February 1, 2022

Study Completion

May 31, 2022

Last Updated

September 19, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

As this is a qualitative study, participants' data, verbatims, and transcription of recorded focus groups can not be disclosed.

Locations