Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Burn Out Among Medical Family Doctors (BOUM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04242862
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Collaborator:
UFR Médecine & Pharmacie - Université Clermont Auvergne
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief 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.


Condition or disease
Burnout, Professional Mental Health Wellness 1 Anxiety Depressive Disorder Occupational Stress

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1536 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Study of the Prevalence, Risk Factors and Protective Factors of Burnout Among General Practitioners in France
Actual Study Start Date : November 1, 2016
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2022



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Anxiety [ Time Frame: Day 1 ]
    Hospital Anxiety and Depression scale will be assessed and related to with demographic information and occupational characteristics

  2. Depression [ Time Frame: Day 1 ]
    Hospital Anxiety and Depression scalewill be assessed and related to with demographic information and occupational characteristics

  3. Stress [ Time Frame: Day 1 ]
    Visual analog scale will be assessed and related to with demographic information and occupational characteristics

  4. Fatigue [ Time Frame: Day 1 ]
    Visual analog scale will be assessed and related to with demographic information and occupational characteristics

  5. sleep disturbance [ Time Frame: Day 1 ]
    Validated questionnaire will be assessed and related to with demographic information and occupational characteristics

  6. 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.

  7. Addictive behaviors [ Time Frame: Day 1 ]
    Alcohol, tobacco and other psychotropic drugs consumption, through questionnaires assessment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Study Population
General practitioners working in France
Criteria

Inclusion Criteria:

  • General practitioners working in France

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04242862


Contacts
Layout table for location contacts
Contact: Lise Laclautre 0473754963 promo_interne_drci@chu-clermontferrand.fr

Locations
Layout table for location information
France
CHU Clermont Ferrand Recruiting
Clermont-Ferrand, Auvergne, France, 63000
Contact: Lise Laclautre    0473754963    promo_interne_drci@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
UFR Médecine & Pharmacie - Université Clermont Auvergne
Investigators
Layout table for investigator information
Principal Investigator: Frederic Dutheil University Hospital, Clermont-Ferrand
Layout table for additonal information
Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT04242862    
Other Study ID Numbers: 2016 BOUM
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
General Practitioners
Private Practice
Models, Organizational
Behavior and Behavior Mechanisms
Test Anxiety Scale
Surveys and Questionnaires
Cross-Sectional Studies
Additional relevant MeSH terms:
Layout table for MeSH terms
Burnout, Professional
Occupational Stress
Depressive Disorder
Burnout, Psychological
Mood Disorders
Mental Disorders
Behavioral Symptoms
Stress, Psychological
Occupational Diseases