Healthcare WorkersNCT03881475
Early Detection of Burnout - Healthcare Workers
An observational study of Healthcare Workers and Stress, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Burnout is a public health issue. Healthcare workers are particularly at risk of burnout with occupational stress identified as the major risk factor. The "Health Work Environment" service is composed of physicians, nurses and psychologist with the aim of providing efficient and adapted care for healthcare workers at… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthcare Workers, Stress, Occupation
- What is being tested?
- questionnaire
- Type of treatment
- Pill or oral medicine
- How many people
- 360 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2019to 30 Jun 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthcare workers at Clermont-Ferrand Hospital
Who may be able to join
- Healthcare workers at Clermont-Ferrand Hospital
- Aged: from 18 years to retirement
Who cannot join
- Participant refusal to participate
- No healthcare workers at Clermont-Ferrand Hospital
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Clermont-Ferrand
Clermont-Ferrand, 63003
Lise LACLAUTRE, 04 73 75 49 63, drci@chu-clermontferrand.fr
Frederic DUTHEIL
About this study
Official title: Validation of an Early Detection Questionnaire of Burnout in Healthcare Workers at Clermont-Ferrand University Hospital
Burnout is a public health issue. Healthcare workers are particularly at risk of burnout with occupational stress identified as the major risk factor. The "Health Work Environment" service is composed of physicians, nurses and psychologist with the aim of providing efficient and adapted care for healthcare workers at CHU of Clermont-Ferrand. In addition, they must ensure a role of primary, secondary and tertiary prevention. With regard to burnout, the majority of the work carried out concerns tertiary prevention, that is to say the care of a person in a situation of burnout. It would be necessary to carry out secondary prevention in order that people at risk of burnout can be detected earlier. However, there is currently no individual questionnaire to detect early burnout
Read the detailed description
Early detection of burnout was designed to provide a better understanding of warning sign of burnout in order to detect earlier workers at risk.
In the present protocol, parameters are measured on several occasions (0, 1 week, at 6 month, at 12 months and then at each occupational visit within 5 years).
Statistical analysis will be performed using Stata software (version 13; Stata-Corp, College Station, Tex., USA). All statistical tests will be two-sided and p<0.05 will be considered significant. After testing for normal distribution (Shapiro-Wilk test), data will be treated either by parametric or non-parametric analyses according to statistical assumptions. Inter-groups comparisons will systematically be performed 1) without adjustment and 2) adjusting on factors liable to be biased between groups.
Analysis will be performed using anova or Kruskal-Wallis (KW) tests. When appropriate (p<0.05), a post-hoc test for multiple comparisons (Tukey-Kramer after anova and Dunn post KW) will be used.
Comparisions of categorical variables will be performed using Chi-squared or Fischer test. Marascuillo's procedure will be performed for multiple comparisons. Relations between quantitative outcomes will be analyzed using correlation coefficients (Pearson or Spearman). Fisher's Z transformation and William's T2 statistic will be performed to compare correlations between variables and within a single group of subjects. Longitudinal data will be treated using mixt-model analyses in order to treat fixed effects group, time and group x time interaction taking into account between and within participant variability.
- Conditions
- Healthcare Workers, Stress, Occupation
- Being tested
- questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
During consultations in occupational medicine (periodic visit and / or visit at the request of the employee), the nurses (or physicians) will propose the passation of the questionnaire to the voluntary agents.
The questionnaire, composed of 79 items with 2 validated questionnaires (HAD and MBI), will be filled using a digital tablet (via the REDCAP software).
Time required to complete the questionnaire 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| healthcare workers | Participants will participate in several sessions where they will complete the questionnaires. The questionnaires will be spaced: 0, 1 week, 6 months, 1 year and then at each occupational visit within 5 years. Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of burnout, anxiety and depression.
To assess the ability of a questionnaire of early detection of burnout, two validated questionnaires will be used: Maslach Burnout Inventory - Human Service Survey (in order to measure level of burnout) and Hospital Anxiety Depression Scale (in order to measure the presence of anxious or depressive symptoms).
No other psychological or physiological measures will be taken.
Measured: at day 1
Level of anxiety
To assess the ability of a questionnaire of early detection of burnout, two validated questionnaires will be used: Maslach Burnout Inventory - Human Service Survey (in order to measure level of burnout) and Hospital Anxiety Depression Scale (in order to measure the presence of anxious or depressive symptoms).
No other psychological or physiological measures will be taken.
Measured: at day 1
Level of depression
To assess the ability of a questionnaire of early detection of burnout, two validated questionnaires will be used: Maslach Burnout Inventory - Human Service Survey (in order to measure level of burnout) and Hospital Anxiety Depression Scale (in order to measure the presence of anxious or depressive symptoms).
No other psychological or physiological measures will be taken.
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start1 Mar 2019
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthcare WorkersStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederic DUTHEIL, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03881475
- Sponsor's protocol ID
- CHU-432
- Status last verified
- Mar 2019
- First submitted
- 8 Mar 2019
- Last updated
- 19 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of an Early Detection Questionnaire of Burnout in Healthcare Workers at Clermont-Ferrand University Hospital
- ClinicalTrials.gov ID
- NCT03881475
- Acronym / sponsor ID
- CHU-432
- Conditions
- Healthcare Workers, Stress, Occupation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 19 Mar 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.
Burnout is a public health issue. Healthcare workers are particularly at risk of burnout with occupational stress identified as the major risk factor. The "Health Work Environment" service is composed of physicians, nurses and psychologist with the aim of providing efficient and adapted care for healthcare workers at CHU of Clermont-Ferrand. In addition, they must ensure a role of primary, secondary and tertiary prevention. With regard to burnout, the majority of the work carried out concerns tertiary prevention, that is to say the care of a person in a situation of burnout. It would be necessary to carry out secondary prevention in order that people at risk of burnout can be detected earlier. However, there is currently no individual questionnaire to detect early burnout
Detailed description
Early detection of burnout was designed to provide a better understanding of warning sign of burnout in order to detect earlier workers at risk.
In the present protocol, parameters are measured on several occasions (0, 1 week, at 6 month, at 12 months and then at each occupational visit within 5 years).
Statistical analysis will be performed using Stata software (version 13; Stata-Corp, College Station, Tex., USA). All statistical tests will be two-sided and p<0.05 will be considered significant. After testing for normal distribution (Shapiro-Wilk test), data will be treated either by parametric or non-parametric analyses according to statistical assumptions. Inter-groups comparisons will systematically be performed 1) without adjustment and 2) adjusting on factors liable to be biased between groups.
Analysis will be performed using anova or Kruskal-Wallis (KW) tests. When appropriate (p<0.05), a post-hoc test for multiple comparisons (Tukey-Kramer after anova and Dunn post KW) will be used.
Comparisions of categorical variables will be performed using Chi-squared or Fischer test. Marascuillo's procedure will be performed for multiple comparisons. Relations between quantitative outcomes will be analyzed using correlation coefficients (Pearson or Spearman). Fisher's Z transformation and William's T2 statistic will be performed to compare correlations between variables and within a single group of subjects. Longitudinal data will be treated using mixt-model analyses in order to treat fixed effects group, time and group x time interaction taking into account between and within participant variability.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthcare workers | – | Other: questionnaireParticipants will participate in several sessions where they will complete the questionnaires. The questionnaires will be spaced: 0, 1 week, 6 months, 1 year and then at each occupational visit within 5 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthcare workers at Clermont-Ferrand Hospital
Key inclusion criteria (2 listed)
- Healthcare workers at Clermont-Ferrand Hospital
- Aged: from 18 years to retirement
Key exclusion criteria (2 listed)
- Participant refusal to participate
- No healthcare workers at Clermont-Ferrand Hospital
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 |
|---|---|---|
| questionnaireDuring consultations in occupational medicine (periodic visit and / or visit at the request of the employee), the nurses (or physicians) will propose the passation of the questionnaire to the voluntary agents. The questionnaire, composed of 79 items with 2 validated questionnaires (HAD and MBI), will be filled using a digital tablet (via the REDCAP software). Time required to complete the questionnaire 10 minutes. | Other | healthcare workers |
Primary outcome
Level of burnout, anxiety and depression.
Time frame: at day 1
To assess the ability of a questionnaire of early detection of burnout, two validated questionnaires will be used: Maslach Burnout Inventory - Human Service Survey (in order to measure level of burnout) and Hospital Anxiety Depression Scale (in order to measure the presence of anxious or depressive symptoms). No other psychological or physiological measures will be taken.
Level of anxiety
Time frame: at day 1
To assess the ability of a questionnaire of early detection of burnout, two validated questionnaires will be used: Maslach Burnout Inventory - Human Service Survey (in order to measure level of burnout) and Hospital Anxiety Depression Scale (in order to measure the presence of anxious or depressive symptoms). No other psychological or physiological measures will be taken.
Level of depression
Time frame: at day 1
To assess the ability of a questionnaire of early detection of burnout, two validated questionnaires will be used: Maslach Burnout Inventory - Human Service Survey (in order to measure level of burnout) and Hospital Anxiety Depression Scale (in order to measure the presence of anxious or depressive symptoms). No other psychological or physiological measures will be taken.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
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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 Healthcare Workers and Stress, 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 2 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: status not confirmed, as of the sponsor's last update on 19 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (04 73 75 49 63, drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of burnout, anxiety and depression. (time frame: at day 1). The study lists 3 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 19 Mar 2019.