Burnout, CaregiverCovIdeDocSNCT04667962
Impact of the Change in Hospital Service of Caregivers During COVID-19 Health Crisis on Operational Strain
An observational study of Burnout, Caregiver, run by Direction Centrale du Service de Santé des Armées at 2 sites in France.
Trial summary
The French Armed Forces Health Service caregivers are confronted with specific operational constraints that require physiological adaptation on a daily basis. These constraints generate an allostatic load resulting from the body's adaptation to the environment through stress response systems. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burnout, Caregiver
- What is being tested?
- Online questionnaire
- How many people
- 307 participants
- Where
- 2 sitesFrance
- Study dates
- 23 Dec 2020to 1 Jun 2021
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: The study population is composed of caregivers from the French Armed Forces Health Service (Medical doctor, nurse, assistant nurse, ...) who have been in employment when the COVID-19 health crisis began in France.
Who may be able to join
- To be caregivers
- Have been in employment between March 15 and May 15, 2020
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
France2 sites
Institut de Recherche Biomédicale des Armées
Brétigny-sur-Orge, 91223
Ecole du Val-de-Grâce
Paris, 75005
About this study
The French Armed Forces Health Service caregivers are confronted with specific operational constraints that require physiological adaptation on a daily basis. These constraints generate an allostatic load resulting from the body's adaptation to the environment through stress response systems. The COVID-19 health crisis has modified the physical and psychological constraints linked to usual activity, in particular by imposing versatility to caregivers.
The research hypothesis is that carers who have undergone activity reorganisations, and in particular a change of service, are more affected by the health crisis than those who have remained in their service and have continued an activity close to their usual practice.
- Conditions
- Burnout, Caregiver
- Being tested
- Online questionnaire
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online questionnaireOther
Participants will have to complete 3 online self-questionnaires: the first one at enrollment, the second one 1 month after enrollment (M1) and the third one 3 months after enrollment (M3). Each questionnaire will take an estimated 20 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| Hospital service change | This group is composed of caregivers who changed hospital service during COVID-19 health crisis. Receives: Other: Online questionnaire | |
| No hospital service change | This group is composed of caregivers who have not changed hospital service during COVID-19 health crisis. Receives: Other: Online questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Burn-out Assessment tool (BAT) score at enrollment.
Burn-out Assessment tool (BAT) score at enrollment will be compared between the "hospital service change" group and the "no hospital service change" group.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start23 Dec 2020
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burnout, CaregiverStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04667962
- Sponsor's protocol ID
- 2020-COVID19-33
- Other IDs
- 2020-A02932-37
- Acronym
- CovIdeDocS
- Status last verified
- Nov 2022
- First submitted
- 13 Dec 2020
- Last updated
- 25 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Change in Hospital Service of Caregivers During COVID-19 Health Crisis on Operational Strain
- ClinicalTrials.gov ID
- NCT04667962
- Acronym / sponsor ID
- CovIdeDocS / 2020-COVID19-33
- Conditions
- Burnout, Caregiver
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 23 Dec 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 16 Dec 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 French Armed Forces Health Service caregivers are confronted with specific operational constraints that require physiological adaptation on a daily basis. These constraints generate an allostatic load resulting from the body's adaptation to the environment through stress response systems. The COVID-19 health crisis has modified the physical and psychological constraints linked to usual activity, in particular by imposing versatility to caregivers.
The research hypothesis is that carers who have undergone activity reorganisations, and in particular a change of service, are more affected by the health crisis than those who have remained in their service and have continued an activity close to their usual practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospital service change | – | Other: Online questionnaireThis group is composed of caregivers who changed hospital service during COVID-19 health crisis. |
| No hospital service change | – | Other: Online questionnaireThis group is composed of caregivers who have not changed hospital service during COVID-19 health crisis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population is composed of caregivers from the French Armed Forces Health Service (Medical doctor, nurse, assistant nurse, ...) who have been in employment when the COVID-19 health crisis began in France.
Key inclusion criteria (2 listed)
- To be caregivers
- Have been in employment between March 15 and May 15, 2020
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Online questionnaireParticipants will have to complete 3 online self-questionnaires: the first one at enrollment, the second one 1 month after enrollment (M1) and the third one 3 months after enrollment (M3). Each questionnaire will take an estimated 20 minutes to complete. | Other | Hospital service change, No hospital service change |
Primary outcome
Burn-out Assessment tool (BAT) score at enrollment.
Time frame: At enrollment
Burn-out Assessment tool (BAT) score at enrollment will be compared between the "hospital service change" group and the "no hospital service change" group.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burnout, Caregiver, run by Direction Centrale du Service de Santé des Armées at 2 sites in France.
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 2 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: finished, as of the sponsor's last update on 25 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Burn-out Assessment tool (BAT) score at enrollment. (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2022.