Burnout, ProfessionalBOUMNCT04242862
Burn Out Among Medical Family Doctors
An observational study of Burnout, Professional and Mental Health Wellness 1, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The main objective of this study is to assess the burnout prevalence among French general practitioners in private practice. As secondary outcomes, this study aim to measure the impact of sociodemographic variables, organizational practice models and workload. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burnout, Professional, Mental Health Wellness 1, Anxiety
- How many people
- 1,536 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2016to 1 Jun 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: General practitioners working in France
Who may be able to join
- General practitioners working in France
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont Ferrand
Clermont-Ferrand, Auvergne, 63000
Lise Laclautre, 0473754963, promo_interne_drci@chu-clermontferrand.fr
About this study
Official title: Study of the Prevalence, Risk Factors and Protective Factors of Burnout Among General Practitioners in France
The main objective of this study is to assess the burnout prevalence among French general practitioners in private practice.
As secondary outcomes, this study aim to measure the impact of sociodemographic variables, organizational practice models and workload. the investigators also intend to characterize the prevalence of depression, anxiety, fatigue and stress, drugs and alcohol consumption, use of psychotropic medication, and preferred strategies to cope with their symptoms.
Read the detailed description
The BOUM protocol is designed to provide a better understanding of the current burnout prevalence among French general practitioners, as well as its risk and protective factors.
In order to fulfil those objectives, the methodologist estimated a 1536 individuals sample size, using an expected prevalence of severe burnout ranged between 10% and 20% (from the the EGPRN study - Soler, J.K., et al., Burnout in European family doctors: the EGPRN study. Family Practice, 2008. 25(4): p. 245-265), thus allowing the investigators to retrieve results with a 95% confidence level and a 2% error margin.
All analyses will be performed in a bilateral formulation for a 5% alpha error under the Stata® software (version 13, StataCorp, College Station, US). A difference will be considered statistically significant for p<0.05. The population will be described as frequency and percentage for the categorical variables, and as mean ± standard deviation or median [interquartile range] for the quantitative variables, according to their statistical distribution (normality studied by the Shapiro-Wilk test). Confidence intervals for population prevalence will be characterised with a binomial test. Comparisons between groups of burnout will be performed using Chi2 or Fisher's exact test for the categorical variables (followed by a Marascuillo post-hoc tests if needed), and by an ANOVA or Kruskal-Wallis test if normality and homoscedasticity not respected (Bartlett test) for the quantitative variables (followed by Tukey-Kramer or Dunn tests when necessary). Finally, considering the variables clinically relevant and those with a pertinent univariate analysis results, a multivariate analyse of ordinal polynomial regression type will be proposed; its results will be expressed as relative risk with 95% confidence intervals and presented as a Forest-plot.
- Conditions
- Burnout, Professional, Mental Health Wellness 1, Anxiety, Depressive Disorder, Occupational Stress
- Keywords
- General Practitioners, Private Practice, Models, Organizational, Behavior and Behavior Mechanisms, Test Anxiety Scale, Surveys and Questionnaires, Cross-Sectional Studies
- Medical subject headings
- Burnout, Professional, Anxiety Disorders, Depressive Disorder, Occupational Stress, Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
Burnout in French General Practitioners
To evaluate the burnout prevalence in French General Practitioners, using the Maslach Burn-Out Inventory questionnaire
Measured: Day 1
Secondary outcomes (7)
Anxiety
Hospital Anxiety and Depression scale will be assessed and related to with demographic information and occupational characteristics
Measured: Day 1
Depression
Hospital Anxiety and Depression scalewill be assessed and related to with demographic information and occupational characteristics
Measured: Day 1
Stress
Visual analog scale will be assessed and related to with demographic information and occupational characteristics
Measured: Day 1
Fatigue
Visual analog scale will be assessed and related to with demographic information and occupational characteristics
Measured: Day 1
sleep disturbance
Validated questionnaire will be assessed and related to with demographic information and occupational characteristics
Measured: Day 1
Psychiatric history and clinical approaches
Participants will be asked about any previous psychiatric diagnosis, suicidal attempt, use of any psychotropic medication and usual stress management approaches.
Measured: Day 1
Addictive behaviors
Alcohol, tobacco and other psychotropic drugs consumption, through questionnaires assessment
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 Nov 2016
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 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.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,536 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Université d'Auvergne
- Responsible party
- Sponsor
- Investigators
- Frederic Dutheil, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04242862
- Sponsor's protocol ID
- 2016 BOUM
- Acronym
- BOUM
- Status last verified
- Jan 2020
- First submitted
- 22 Jan 2020
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Prevalence, Risk Factors and Protective Factors of Burnout Among General Practitioners in France
- ClinicalTrials.gov ID
- NCT04242862
- Acronym / sponsor ID
- BOUM / 2016 BOUM
- Conditions
- Burnout, Professional, Mental Health Wellness 1, Anxiety, Depressive Disorder, Occupational Stress
- Keywords
- General Practitioners, Private Practice, Models, Organizational, Behavior and Behavior Mechanisms, Test Anxiety Scale, Surveys and Questionnaires, Cross-Sectional Studies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,536 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Université d'Auvergne
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 27 Jan 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 main objective of this study is to assess the burnout prevalence among French general practitioners in private practice.
As secondary outcomes, this study aim to measure the impact of sociodemographic variables, organizational practice models and workload. the investigators also intend to characterize the prevalence of depression, anxiety, fatigue and stress, drugs and alcohol consumption, use of psychotropic medication, and preferred strategies to cope with their symptoms.
Detailed description
The BOUM protocol is designed to provide a better understanding of the current burnout prevalence among French general practitioners, as well as its risk and protective factors.
In order to fulfil those objectives, the methodologist estimated a 1536 individuals sample size, using an expected prevalence of severe burnout ranged between 10% and 20% (from the the EGPRN study - Soler, J.K., et al., Burnout in European family doctors: the EGPRN study. Family Practice, 2008. 25(4): p. 245-265), thus allowing the investigators to retrieve results with a 95% confidence level and a 2% error margin.
All analyses will be performed in a bilateral formulation for a 5% alpha error under the Stata® software (version 13, StataCorp, College Station, US). A difference will be considered statistically significant for p<0.05. The population will be described as frequency and percentage for the categorical variables, and as mean ± standard deviation or median [interquartile range] for the quantitative variables, according to their statistical distribution (normality studied by the Shapiro-Wilk test). Confidence intervals for population prevalence will be characterised with a binomial test. Comparisons between groups of burnout will be performed using Chi2 or Fisher's exact test for the categorical variables (followed by a Marascuillo post-hoc tests if needed), and by an ANOVA or Kruskal-Wallis test if normality and homoscedasticity not respected (Bartlett test) for the quantitative variables (followed by Tukey-Kramer or Dunn tests when necessary). Finally, considering the variables clinically relevant and those with a pertinent univariate analysis results, a multivariate analyse of ordinal polynomial regression type will be proposed; its results will be expressed as relative risk with 95% confidence intervals and presented as a Forest-plot.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- General practitioners working in France
Key inclusion criteria (1 listed)
- General practitioners working in France
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.
Primary outcome
Burnout in French General Practitioners
Time frame: Day 1
To evaluate the burnout prevalence in French General Practitioners, using the Maslach Burn-Out Inventory questionnaire
7 secondary outcomes
Anxiety
Time frame: Day 1
Depression
Time frame: Day 1
Stress
Time frame: Day 1
Fatigue
Time frame: Day 1
sleep disturbance
Time frame: Day 1
Psychiatric history and clinical approaches
Time frame: Day 1
Addictive behaviors
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
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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.
Frederic Dutheil principal investigator
University Hospital, Clermont-Ferrand
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 and Mental Health Wellness 1, run by University Hospital, Clermont-Ferrand 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 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 27 Jan 2020. 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 Lise Laclautre (0473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Burnout in French General Practitioners (time frame: Day 1). 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 27 Jan 2020.