NCT04346810

Brief Summary

The intense health crisis due to COVID-19 led to a profound reorganization of the activities at theatres, recovery rooms and the intensive care units. The caregivers are facing several issues and are daily exposed to an intensification of the work. Assessing the stress and the well-being of the caregivers is very important in this context.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

April 8, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 15, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

April 15, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2020

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

April 17, 2020

Status Verified

April 1, 2020

Enrollment Period

4 months

First QC Date

April 8, 2020

Last Update Submit

April 15, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Stress in a recovery room transformed into an intensive care unit versus a conventional intensive care unit

    stress level of caregivers managing patients with coronavirus infection needing airway support or resuscitation. The level of stress will be quantified with the Maslach burnout Inventory.

    A 3 months period from the starting of the pandemic

Study Arms (2)

Recovery room caregivers

Caregivers working at a recovery room shifted into an intensive care unit for the management of patients suffering from coronavirus infection and needing a resuscitation

Other: Patient management suffering of coronavirus infection

Intensive care unit caregivers

Caregivers working at a conventional intensive care unit for the management of patients suffering from coronavirus infection and needing a resuscitation

Other: Patient management suffering of coronavirus infection

Interventions

Welle-being and stress of the caregivers

Intensive care unit caregiversRecovery room caregivers

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Caregivers working in the recovery room shifted into an intensive care unit or in the conventional intensive care unit

You may qualify if:

  • Consent to participation; caregivers working at recovery room; caregiver working at intensive care unit

You may not qualify if:

  • refusal of participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Staloff J, Diop M, Matuk R, Riese A, White J. Caring for Caregivers: Burnout and Resources for Caregivers in Rhode Island. R I Med J (2013). 2018 Nov 1;101(9):10-11. No abstract available.

    PMID: 30384512BACKGROUND
  • Pastores SM. Burnout Syndrome in ICU Caregivers: Time to Extinguish! Chest. 2016 Jul;150(1):1-2. doi: 10.1016/j.chest.2016.03.024. No abstract available.

    PMID: 27396768BACKGROUND

MeSH Terms

Conditions

COVID-19Caregiver BurdenStress, Psychological

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesBehavioral SymptomsBehavior

Central Study Contacts

Hakim Harkouk, M.D.

CONTACT

Dominique Fletcher, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 8, 2020

First Posted

April 15, 2020

Study Start

April 15, 2020

Primary Completion

August 15, 2020

Study Completion

September 1, 2020

Last Updated

April 17, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

No plan to share data with other researchers