COVID-19NCT04346810
Burnout Among Caregivers Facing COVID-19 Health Crisis at a Non-conventional Intensive Care Unit Compared to a Conventional Intensive Care Unit
An observational study of COVID-19 and Burnout, Caregiver, run by Hôpital Raymond Poincaré.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19, Burnout, Caregiver, Intensive Care Unit
- What is being tested?
- Patient management suffering of coronavirus infection
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2020to 1 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Caregivers working in the recovery room shifted into an intensive care unit or in the conventional intensive care unit
Who may be able to join
- Consent to participation; caregivers working at recovery room; caregiver working at intensive care unit
Who cannot join
- refusal of participation
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed description
The current period of intense and prolonged health crisis has necessitated a profound reorganization of the activities and organizations of the intensive care hospital services in order to be able to cope with it.
Caregivers are at the heart of the management of this crisis and are exposed daily to these situations of repeated emergencies, an intensification of the pace of work and difficulties in care.
In this context, it seemed important to us to try to quantify this pressure of care, in order to be able to offer in second care adapted to caregivers who would like it.
The assessment of the mental state of the caregivers as well as the collection of the feelings and perceptions on the current crisis and its management will be carried out by anonymous and voluntary self-questionnaire in collaboration with the service of professional pathologies and occupational medicine of the hospital structure
- Being tested
- Patient management suffering of coronavirus infection
- Medical subject headings
- COVID-19, Caregiver Burden, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient management suffering of coronavirus infectionOther
Welle-being and stress of the caregivers
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Patient management suffering of coronavirus infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: A 3 months period from the starting of the pandemic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start15 Apr 2020 (estimated)
- Primary completion15 Aug 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital Raymond Poincaré
- Sponsor type
- University, hospital or other
- Collaborators
- Dominique FLETCHER MD-PhD, Guillaume GERI MD-PhD, Clement DURET MD
- Responsible party
- Principal investigator, HARKOUK Hakim, Hôpital Raymond Poincaré
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04346810
- Sponsor's protocol ID
- CSC19APR
- Status last verified
- Apr 2020
- First submitted
- 8 Apr 2020
- Last updated
- 17 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share data with other researchers
Publications
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.
PubMed 30384512Pastores 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.
PubMed 27396768
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burnout Among Caregivers Facing COVID-19 Health Crisis at a Non-conventional Intensive Care Unit Compared to a Conventional Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04346810
- Acronym / sponsor ID
- CSC19APR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hôpital Raymond PoincaréUniversity, hospital or other
- Collaborators
- Dominique FLETCHER MD-PhD, Guillaume GERI MD-PhD, Clement DURET MD
- Study start
- 15 Apr 2020 (estimated)
- Primary completion
- 15 Aug 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 15 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The current period of intense and prolonged health crisis has necessitated a profound reorganization of the activities and organizations of the intensive care hospital services in order to be able to cope with it.
Caregivers are at the heart of the management of this crisis and are exposed daily to these situations of repeated emergencies, an intensification of the pace of work and difficulties in care.
In this context, it seemed important to us to try to quantify this pressure of care, in order to be able to offer in second care adapted to caregivers who would like it.
The assessment of the mental state of the caregivers as well as the collection of the feelings and perceptions on the current crisis and its management will be carried out by anonymous and voluntary self-questionnaire in collaboration with the service of professional pathologies and occupational medicine of the hospital structure
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recovery room caregivers | – | Other: Patient management suffering of coronavirus infectionCaregivers working at a recovery room shifted into an intensive care unit for the management of patients suffering from coronavirus infection and needing a resuscitation |
| Intensive care unit caregivers | – | Other: Patient management suffering of coronavirus infectionCaregivers working at a conventional intensive care unit for the management of patients suffering from coronavirus infection and needing a resuscitation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Caregivers working in the recovery room shifted into an intensive care unit or in the conventional intensive care unit
Key inclusion criteria (1 listed)
- Consent to participation; caregivers working at recovery room; caregiver working at intensive care unit
Key exclusion criteria (1 listed)
- refusal of participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient management suffering of coronavirus infectionWelle-being and stress of the caregivers | Other | Intensive care unit caregivers, Recovery room caregivers |
Primary outcome
Stress in a recovery room transformed into an intensive care unit versus a conventional intensive care unit
Time frame: A 3 months period from the starting of the pandemic
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2020.
- Background: PubMed 30384512Staloff 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.
- Background: PubMed 27396768Pastores 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.
- Individual participant dataSharing planned: No. No plan to share data with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Burnout, Caregiver, run by Hôpital Raymond Poincaré.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hakim Harkouk, M.D. (0033149095422, hakim.harkouk@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress in a recovery room transformed into an intensive care unit versus a conventional intensive care unit (time frame: A 3 months period from the starting of the pandemic). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04346810, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2020.