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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

France1 site
  • Chu Brest

    Brest, Brittany Region, 29200

Other trials in France

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.

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.

  1. global health

    Questionnaire on global health assessment with physical and psychological healt assessment and well being.

    Measured: july-august 2020

Secondary outcomes (1)
  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.

  1. First posted19 Apr 2021
  2. Study start1 Jul 2020
  3. Primary completion31 Aug 2020
  4. Study completion1 Sep 2020

Resources

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)
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

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.

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