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Status unknownNCT04242862BOUMUpdated Jan 27, 2020

Burn Out Among Medical Family Doctors

An observational study in Burnout, Professional, Mental Health Wellness 1 and Anxiety, sponsored by University Hospital, Clermont-Ferrand. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-27.

Sponsored by University Hospital, Clermont-Ferrand · Observational

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
1,536
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • 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
03

In context

Burnout, Professional

214 studies on the registry are indexed under Burnout, Professional; 33 are open to participants now.

This study's planned enrollment of 1,536 is above the median of 200 across 53 observational studies indexed under Burnout, Professional.

Browse Burnout, Professional studies →

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Study population

General practitioners working in France

Inclusion criteria

  • General practitioners working in France

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
1,536 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Burnout in French General Practitioners

    To evaluate the burnout prevalence in French General Practitioners, using the Maslach Burn-Out Inventory questionnaire

    Time frame: Day 1

Secondary outcomes

  1. Anxiety

    Hospital Anxiety and Depression scale will be assessed and related to with demographic information and occupational characteristics

    Time frame: Day 1

  2. Depression

    Hospital Anxiety and Depression scalewill be assessed and related to with demographic information and occupational characteristics

    Time frame: Day 1

  3. Stress

    Visual analog scale will be assessed and related to with demographic information and occupational characteristics

    Time frame: Day 1

  4. Fatigue

    Visual analog scale will be assessed and related to with demographic information and occupational characteristics

    Time frame: Day 1

  5. sleep disturbance

    Validated questionnaire will be assessed and related to with demographic information and occupational characteristics

    Time frame: Day 1

  6. 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.

    Time frame: Day 1

  7. Addictive behaviors

    Alcohol, tobacco and other psychotropic drugs consumption, through questionnaires assessment

    Time frame: Day 1

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04242862
Lead sponsor
University Hospital, Clermont-Ferrand
Collaborators
UFR Médecine & Pharmacie - Université Clermont Auvergne
Responsible party
Sponsor
First posted
Jan 27, 2020
Start date
Nov 1, 2016
Primary completion
Jun 1, 2021 (estimated)
Completion
Jun 1, 2022 (estimated)
Last update
Jan 27, 2020

Study contacts

Lise Laclautre
Contact
promo_interne_drci@chu-clermontferrand.fr
0473754963
Frederic Dutheil
principal investigator · University Hospital, Clermont-Ferrand

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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