Cross-Sectional StudiesNCT04136899
Burn Out and Quality of Life at French General Practioners
An observational study of Cross-Sectional Studies, run by Albert TRINH-DUC at 1 site in France.
Trial summary
The suffering of caregivers is constantly increasing. General medicine, because of its primary role in primary care, is particularly exposed to the risk of burn-out and must protect itself. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Cross-Sectional Studies
- What is being tested?
- Dukes scale
- How many people
- 1,100 participants
- Where
- 1 siteFrance
- Study dates
- 20 Aug 2019to 20 Aug 2019
- 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 30 to 75 years
- All sexes
- Adult, Older adult
Study population: All french general practitioner in activity
Who may be able to join
- french general practitioner in liberal activity
Who cannot join
- retired doctor
- junior general practioner
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Burn Out and Quality of Life at French General Practioners: is There a Link
The suffering of caregivers is constantly increasing. General medicine, because of its primary role in primary care, is particularly exposed to the risk of burn-out and must protect itself. The aim of this study was to find an inverse relationship between health-related quality of life and being severely burned by French general practitioners.
Read the detailed description
descriptive quantitative cross-sectional study
- Conditions
- Cross-Sectional Studies
- Being tested
- Dukes scale
- Keywords
- burn out, quality of life, general practioners, french
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dukes scaleOther
Also called Maslach Burn-out Inventory Scale
collection of questionnaires
What is being measured
The primary outcome is the main question the study is designed to answer.
Assesment of Burn-out
Maslach Burn-out Inventory scale, 22 Items sort to 0 (never) at 6 (every day) 3 class : An emotional exhaustion (EE), depersonalization (DP) and a reduction of personal accomplishment (AP)
- The emotional exhaustion (when emotional resources are exhausted, when the workers can no longer give their best, psychologically speaking.)
- The Depersonalization (reflects withdrawal, indifference to work)
- The lose of personal accomplishment (devaluation, negative self-evaluation at work)
Our study focused on severe burn-out, defined by the combination of high EE and DP scores and low AP scores:
- A high EE is defined by a score > 30
- A high PD is defined by a score > 12
- A low PA is defined by a score < 33.
Measured: 30 days
Assesment quality of life: Dukes Scale
The Duke Health Profile 17 items questionnaire. It assesses health-related quality of life and has 10 dimensions.
The score of each of the 10 dimensions matches with the sum of the item scores, standardized from 0 to 100:
- For the 6 health scores (general, physical, mental, social, perceived health and self-esteem) 100 specifies the best HRQoL,
- For the 4 scores of the dysfunction dimension (anxiety, depression, pain, disability), 100 specifies the most significant dysfunction
Measured: 30 days
Secondary outcomes (3)
Socio-demographic data
- age, (years)
- sex, (female, male)
- children, (children number)
Measured: 30 days
Mode of practice
- mode of practice (alone, group, liberal..),
- the number of hours worked, (hours)
- the number of monthly guards, (months)
- the number of daily acts, (acts number)
- the number of weeks of annual leave, (weeks)
Measured: 30 days
Leisure time
- he practice of a sports or leisure activity, (yes, not)
- he presence or absence of a work stoppage during the last twelve months (weeks)
- the duration, the need to have had to adjust his working time (yes, not)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start20 Aug 2019
- Primary completion20 Aug 2019
- Study completion20 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cross-Sectional StudiesStudies 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
- Cross-sectional
- Enrolment
- 1,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert TRINH-DUC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Albert TRINH-DUC, Centre Hospitalier St Esprit
- Investigators
- Albert TRINH-DUC, MD, Study director, Centre Hospitalier St Esprit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04136899
- Sponsor's protocol ID
- CHSEsprit AGEN
- Status last verified
- Oct 2019
- First submitted
- 30 Aug 2019
- Last updated
- 23 Oct 2019
- 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 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burn Out and Quality of Life at French General Practioners: is There a Link
- ClinicalTrials.gov ID
- NCT04136899
- Acronym / sponsor ID
- CHSEsprit AGEN
- Conditions
- Cross-Sectional Studies
- Keywords
- burn out, quality of life, general practioners, french
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,100 participants (actual)
- Lead sponsor
- Albert TRINH-DUCUniversity, hospital or other
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- 20 Aug 2019 (actual)
- Study completion
- 20 Aug 2019 (actual)
- First posted
- 23 Oct 2019 (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 suffering of caregivers is constantly increasing. General medicine, because of its primary role in primary care, is particularly exposed to the risk of burn-out and must protect itself. The aim of this study was to find an inverse relationship between health-related quality of life and being severely burned by French general practitioners.
Detailed description
descriptive quantitative cross-sectional study
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All french general practitioner in activity
Key inclusion criteria (1 listed)
- french general practitioner in liberal activity
Key exclusion criteria (2 listed)
- retired doctor
- junior general practioner
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 |
|---|---|---|
| Dukes scaleAlso: Maslach Burn-out Inventory Scalecollection of questionnaires | Other | – |
Primary outcome
Assesment of Burn-out
Time frame: 30 days
Maslach Burn-out Inventory scale, 22 Items sort to 0 (never) at 6 (every day) 3 class : An emotional exhaustion (EE), depersonalization (DP) and a reduction of personal accomplishment (AP) * The emotional exhaustion (when emotional resources are exhausted, when the workers can no longer give their best, psychologically speaking.) * The Depersonalization (reflects withdrawal, indifference to work) * The lose of personal accomplishment (devaluation, negative self-evaluation at work) Our study focused on severe burn-out, defined by the combination of high EE and DP scores and low AP scores: * A high EE is defined by a score > 30 * A high PD is defined by a score > 12 * A low PA is defined by a score < 33.
Assesment quality of life: Dukes Scale
Time frame: 30 days
The Duke Health Profile 17 items questionnaire. It assesses health-related quality of life and has 10 dimensions. The score of each of the 10 dimensions matches with the sum of the item scores, standardized from 0 to 100: * For the 6 health scores (general, physical, mental, social, perceived health and self-esteem) 100 specifies the best HRQoL, * For the 4 scores of the dysfunction dimension (anxiety, depression, pain, disability), 100 specifies the most significant dysfunction
3 secondary outcomes
Socio-demographic data
Time frame: 30 days
Mode of practice
Time frame: 30 days
Leisure time
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2019.
- 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.
Albert TRINH-DUC, MD study director
Centre Hospitalier St Esprit
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 Cross-Sectional Studies, run by Albert TRINH-DUC 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 2 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: finished, as of the sponsor's last update on 23 Oct 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assesment of Burn-out (time frame: 30 days). The study lists 2 primary outcomes in all. 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 23 Oct 2019.