Burnout, ProfessionalBURNOUT ADVICENCT05011435
Assessment of the Feasibility of Using a Smartphone Application for the Prevention and Screening of Burnout (BURNOUT ADVICE)
An observational study of Burnout, Professional, run by Weprom at 1 site in France.
Trial summary
Burnout syndrome has been recognized as a mental illness since 2020. All workers can be affected. The consequences are multiple and often serious, ranging from stoppage of work to depression or even suicide. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Burnout, Professional
- What is being tested?
- web-application for burnout
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2021to Sep 2022
- How long will I take part?
- 6 Months
- 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 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The population will include the first 200 users of the application who did not object to the use of their data for this assessment.
Who may be able to join
- Person aged 18 to 64
- Exercising a professional activity
- User informed of the use of this data and not objecting to it
Who cannot join
- Professionals on sick leave
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
ILC
Le Mans, 72000
Fabrice DENIS, Pr, f.denis@ilcgroupe.fr
Fabrice DENIS, P
About this study
Official title: Assessment of the Feasibility of Using a Smartphone Application for the Prevention and Screening of Burnout
Burnout syndrome has been recognized as a mental illness since 2020. All workers can be affected. The consequences are multiple and often serious, ranging from stoppage of work to depression or even suicide. According to a 2019 survey by Malakoff, 56% of employees are in "professional or personal fragility", but the statistics are incomplete.
In the medical community, the burnout rate is doubled compared to the general population.
Read more
The diagnosis of pre-burnout can precede a burnout by several months, an early treatment can then reduce complications and improve the quality of life at work.
On a study model on health data already carried out as part of a cancer detection application in smokers which involved 7000 users and which showed the ability to of such an application to detect curable symptomatic cancers from questionnaires (24% with application against 9% without application), we will carry out a descriptive evaluation of the use of an application to detect pre-burnout, burnout and depressive syndrome in a worker population. In the event of a risk alert of pre-burnout, burnout or depressive syndrome, the application will display a message to the user suggesting that he consult his general practitioner or put him in contact with a doctor through a teleconsultation via a dedicated platform.
This first study will assess the feasibility and acceptability of an early detection approach among professionals of a state of "fragility" (pre-burnout, burnout or depressive syndrome). Subsequently, a larger study will evaluate the effectiveness of this application for the early detection of burnout among professionals, its management and the reduction of costs for the healthcare system and society.
- Conditions
- Burnout, Professional
- Being tested
- web-application for burnout
- Medical subject headings
- Burnout, Professional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
web-application for burnoutDevice
Also called Burnout Advisor
Use of burnout advisor web-application for detection of professional burnout
| Study group | Role | What they receive |
|---|---|---|
| Users | users of the web-application Receives: Device: web-application for burnout |
What is being measured
The primary outcome is the main question the study is designed to answer.
usefulness
number of users who find the application useful
Measured: 6 months
Secondary outcomes (2)
alert
Description of alerts triggered by algorithms
Measured: 6 months
Consultation
Number of relevant consultations (or teleconsultations) after an alert
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start15 Sep 2021
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burnout, ProfessionalStudies 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
- 200 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Weprom
- Sponsor type
- University, hospital or other
- Collaborators
- Kelindi
- Responsible party
- Sponsor
- Investigators
- Fabrice DENIS, Pr, Study director, ILC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05011435
- Sponsor's protocol ID
- WP-2021-01
- Acronym
- BURNOUT ADVICE
- Status last verified
- Aug 2021
- First submitted
- 11 Aug 2021
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Feasibility of Using a Smartphone Application for the Prevention and Screening of Burnout
- ClinicalTrials.gov ID
- NCT05011435
- Acronym / sponsor ID
- BURNOUT ADVICE / WP-2021-01
- Conditions
- Burnout, Professional
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- WepromUniversity, hospital or other
- Collaborators
- Kelindi
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 18 Aug 2021 (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.
Burnout syndrome has been recognized as a mental illness since 2020. All workers can be affected. The consequences are multiple and often serious, ranging from stoppage of work to depression or even suicide. According to a 2019 survey by Malakoff, 56% of employees are in "professional or personal fragility", but the statistics are incomplete.
In the medical community, the burnout rate is doubled compared to the general population.
The diagnosis of pre-burnout can precede a burnout by several months, an early treatment can then reduce complications and improve the quality of life at work.
On a study model on health data already carried out as part of a cancer detection application in smokers which involved 7000 users and which showed the ability to of such an application to detect curable symptomatic cancers from questionnaires (24% with application against 9% without application), we will carry out a descriptive evaluation of the use of an application to detect pre-burnout, burnout and depressive syndrome in a worker population. In the event of a risk alert of pre-burnout, burnout or depressive syndrome, the application will display a message to the user suggesting that he consult his general practitioner or put him in contact with a doctor through a teleconsultation via a dedicated platform.
This first study will assess the feasibility and acceptability of an early detection approach among professionals of a state of "fragility" (pre-burnout, burnout or depressive syndrome). Subsequently, a larger study will evaluate the effectiveness of this application for the early detection of burnout among professionals, its management and the reduction of costs for the healthcare system and society.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Users | – | Device: web-application for burnoutusers of the web-application |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The population will include the first 200 users of the application who did not object to the use of their data for this assessment.
Key inclusion criteria (3 listed)
- Person aged 18 to 64
- Exercising a professional activity
- User informed of the use of this data and not objecting to it
Key exclusion criteria (1 listed)
- Professionals on sick leave
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 |
|---|---|---|
| web-application for burnoutAlso: Burnout AdvisorUse of burnout advisor web-application for detection of professional burnout | Device | Users |
Primary outcome
usefulness
Time frame: 6 months
number of users who find the application useful
2 secondary outcomes
alert
Time frame: 6 months
Consultation
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
- Individual participant dataSharing planned: No
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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.
Fabrice DENIS, Pr study director
ILC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burnout, Professional, run by Weprom at 1 site 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 3 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 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Magali BALAVOINE (241682940 ext. 0033, m.balavoine@ilcgroupe.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
usefulness (time frame: 6 months). 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 3 Nov 2021.