Occupational StressSAMAFNCT04849546
Staff Physical and Mental Health Assessment in the Aftermath of the First Peak of the Covid-19 Outbreak
An observational study of Occupational Stress, run by University Hospital, Brest at 1 site in France.
Trial summary
Objectives: This study compare the mental health impact and psychosocial perception of healthcare workers and non healthcare workers in hospital after the first peak of COVID-19 outbreak in France. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Occupational Stress
- How many people
- 1,491 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2020to 1 Sep 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 to 70 years
- All sexes
- Adult, Older adult
Study population: all workers from brest teaching hospital and private health clinic in Brest
Who may be able to join
- working in Brest teaching hospital or brest health clinic more than one year and aged> 18
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Physical and Mental Health of Private and Public Care Facilities Personnel in the Brestois Sector Following the First Peak of the Covid-19 Outbreak
Objectives: This study compare the mental health impact and psychosocial perception of healthcare workers and non healthcare workers in hospital after the first peak of COVID-19 outbreak in France.
Methods: The validated SATIN questionnaire with specific scoring was used to collect data on health and psychosocial factors. A self-administered online questionnaire was send to all workers of the hospital in June 2020. A multinomial regression model was created to assess differences and risk factors in outcomes between healthcare workers and non healthcare workers. Variables were adjusted for age, sexe, frontline workplaces and experience at hospital.
Read the detailed description
The survey was conducted between 01 th of July and 31th of August 2020 and involved all workers employed in a teaching hospital in France. The total number of workers was 7299.
The Inclusion criteria were as follows: working in the hospital since more than one year, adults over than 18 years, acceptance.
Questionnaire After SATIN questionnaire authors allowing, we created a specific questionnaire with all original questions and some additional on workplaces and demographics' data. In first question, participants must check that they met inclusion criteria and accept to be included in this survey. An open question was available at the end for remarks.
86 questions in 6 parts: 1. Personnel and Professional Identification (10 questions) 2. Health reports (16 questions) 3. Work strain and capacities (8 questions) 4. Working environment (39 questions) 5. Work assessment (4 questions) 6. Supplementary questions for occupational physician (9 questions) Each question had five possible answers and each answer is linked to a specific score. Mean of scores were calculated in each part of the questionnaire: health reports (physical health, psychic health, physical symptoms, psycho-somatic symptoms, and stress), work strain and ability, working environment (physical environment, activity, framework of activities and organizational context), self-assessed work conditions in their entirety. The scores of each part were interpreted as follows: <2.5 poor health or negative perception, 2.5-3.5 mild health or perception, > 3.5 good health or positive perception. Global health and general workplace environment self-evaluation were scored in a second time with respectively health reports and working environment scores.
Demographic data were self-reported by the participants including occupation, sexe (male/female), age (<34, 35-44, 45-54, >55 years), time at workplace (<5, 6-15, 16-26,>26 years), shift work or night work (never, rarely, regularly, often/very often).
Statistical analyses. Data analysis was performed using R software (R Foundation for Statistical Computing, Vienna, Austria). The results for continuous variables were shown as medians with Interquartile range (IQRs). The ranked data, which were ranked from each part of the questionnaire, are presented as numbers and percentages. Participants were divided into three groups according to the previously reported questionnaire cut-off (<2.5; 2.5-3.5; > 3.5). Doctor, nurse, medical student, nurse assistant, midwife, paramedics, physiotherapist and radiographer were included in the subgroup "health care worker", other participants were included in the subgroup "non healthcare worker". We also made an analysis by subgroup of workers if they regularly or not worked in a COVID 19 dedicated sector. A multinomial logistic regression analysis was performed and the associations between risk factors and outcomes are presented as Odds Ratio (ORs) and 95% Confidence Intervals (Cis), after adjustment for cofounders including, gender, age, years at workplace. The significant level was set at p= 0.05.
- Conditions
- Occupational Stress
- Keywords
- healtcare worker, COVID 19
- Medical subject headings
- Occupational Stress, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
global health
Questionnaire on global health assessment with physical and psychological healt assessment and well being.
Measured: july-august 2020
Secondary outcomes (1)
psychosocial factors
validated questionnaire on psychosocial factors
Measured: july- august 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start1 Jul 2020
- Primary completion31 Aug 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occupational StressStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 1,491 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04849546
- Sponsor's protocol ID
- SAMAF - 29BRC21.0125
- Acronym
- SAMAF
- Status last verified
- Feb 2021
- First submitted
- 15 Apr 2021
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Physical and Mental Health of Private and Public Care Facilities Personnel in the Brestois Sector Following the First Peak of the Covid-19 Outbreak
- ClinicalTrials.gov ID
- NCT04849546
- Acronym / sponsor ID
- SAMAF / SAMAF - 29BRC21.0125
- Conditions
- Occupational Stress
- Keywords
- healtcare worker, COVID 19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,491 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 19 Apr 2021 (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.
Objectives: This study compare the mental health impact and psychosocial perception of healthcare workers and non healthcare workers in hospital after the first peak of COVID-19 outbreak in France.
Methods: The validated SATIN questionnaire with specific scoring was used to collect data on health and psychosocial factors. A self-administered online questionnaire was send to all workers of the hospital in June 2020. A multinomial regression model was created to assess differences and risk factors in outcomes between healthcare workers and non healthcare workers. Variables were adjusted for age, sexe, frontline workplaces and experience at hospital.
Detailed description
The survey was conducted between 01 th of July and 31th of August 2020 and involved all workers employed in a teaching hospital in France. The total number of workers was 7299.
The Inclusion criteria were as follows: working in the hospital since more than one year, adults over than 18 years, acceptance.
Questionnaire After SATIN questionnaire authors allowing, we created a specific questionnaire with all original questions and some additional on workplaces and demographics' data. In first question, participants must check that they met inclusion criteria and accept to be included in this survey. An open question was available at the end for remarks.
86 questions in 6 parts: 1. Personnel and Professional Identification (10 questions) 2. Health reports (16 questions) 3. Work strain and capacities (8 questions) 4. Working environment (39 questions) 5. Work assessment (4 questions) 6. Supplementary questions for occupational physician (9 questions) Each question had five possible answers and each answer is linked to a specific score. Mean of scores were calculated in each part of the questionnaire: health reports (physical health, psychic health, physical symptoms, psycho-somatic symptoms, and stress), work strain and ability, working environment (physical environment, activity, framework of activities and organizational context), self-assessed work conditions in their entirety. The scores of each part were interpreted as follows: <2.5 poor health or negative perception, 2.5-3.5 mild health or perception, > 3.5 good health or positive perception. Global health and general workplace environment self-evaluation were scored in a second time with respectively health reports and working environment scores.
Demographic data were self-reported by the participants including occupation, sexe (male/female), age (<34, 35-44, 45-54, >55 years), time at workplace (<5, 6-15, 16-26,>26 years), shift work or night work (never, rarely, regularly, often/very often).
Statistical analyses. Data analysis was performed using R software (R Foundation for Statistical Computing, Vienna, Austria). The results for continuous variables were shown as medians with Interquartile range (IQRs). The ranked data, which were ranked from each part of the questionnaire, are presented as numbers and percentages. Participants were divided into three groups according to the previously reported questionnaire cut-off (<2.5; 2.5-3.5; > 3.5). Doctor, nurse, medical student, nurse assistant, midwife, paramedics, physiotherapist and radiographer were included in the subgroup "health care worker", other participants were included in the subgroup "non healthcare worker". We also made an analysis by subgroup of workers if they regularly or not worked in a COVID 19 dedicated sector. A multinomial logistic regression analysis was performed and the associations between risk factors and outcomes are presented as Odds Ratio (ORs) and 95% Confidence Intervals (Cis), after adjustment for cofounders including, gender, age, years at workplace. The significant level was set at p= 0.05.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- all workers from brest teaching hospital and private health clinic in Brest
Key inclusion criteria (1 listed)
- working in Brest teaching hospital or brest health clinic more than one year and aged> 18
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
global health
Time frame: july-august 2020
Questionnaire on global health assessment with physical and psychological healt assessment and well being.
1 secondary outcome
psychosocial factors
Time frame: july- august 2020
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 19 Apr 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Occupational Stress, run by University Hospital, Brest 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 1 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 19 Apr 2021. 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?
global health (time frame: july-august 2020). 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 Apr 2021.