- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04242862
Burn Out Among Medical Family Doctors (BOUM)
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.
Study Overview
Status
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Auvergne
-
Clermont-Ferrand, Auvergne, France, 63000
- Recruiting
- CHU Clermont Ferrand
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Study Population
Description
Inclusion Criteria:
- General practitioners working in France
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety
Time Frame: Day 1
|
Hospital Anxiety and Depression scale will be assessed and related to with demographic information and occupational characteristics
|
Day 1
|
Depression
Time Frame: Day 1
|
Hospital Anxiety and Depression scalewill be assessed and related to with demographic information and occupational characteristics
|
Day 1
|
Stress
Time Frame: Day 1
|
Visual analog scale will be assessed and related to with demographic information and occupational characteristics
|
Day 1
|
Fatigue
Time Frame: Day 1
|
Visual analog scale will be assessed and related to with demographic information and occupational characteristics
|
Day 1
|
sleep disturbance
Time Frame: Day 1
|
Validated questionnaire will be assessed and related to with demographic information and occupational characteristics
|
Day 1
|
Psychiatric history and clinical approaches
Time Frame: Day 1
|
Participants will be asked about any previous psychiatric diagnosis, suicidal attempt, use of any psychotropic medication and usual stress management approaches.
|
Day 1
|
Addictive behaviors
Time Frame: Day 1
|
Alcohol, tobacco and other psychotropic drugs consumption, through questionnaires assessment
|
Day 1
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016 BOUM
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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