COVID-19NCT04344145
Exhaustion and Needs in Frontline COVID-19 Healthcare Workers: Cross-sectional Study in a Belgian Population
An observational study of COVID-19, run by Université Libre de Bruxelles at 5 sites in Belgium.
Trial summary
Background: In the Covid-19 pandemic context, all healthcare teams face clinical, organizational and technical challenges given the contagion, severity and mortality characteristics of the disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- How many people
- 693 participants
- Where
- 5 sitesBelgium
- Study dates
- 16 Apr 2020to 29 May 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: This study targets healthcare workers in Belgian hospital. It targets any physician, nurse or physiotherapist in emergency, non-intensive Covid-19 and intensive Covid-19 care unit (target group) and in usual medical care unit (control group). There is no sampling method. Participation is on voluntary basis.
Who may be able to join
- Ability to read, speak and write in French;
- Being professionally active (doctor, nurse or physiotherapist) within a medical care unit;
Who cannot join
- Having been off work (for medical, professional or personal reasons) for ≥ 3 weeks before first assessment time.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Belgium5 sites
Hôpital de Warquignies
Boussu, Hainaut, 7300
Erasme Hospital CUB
Brussels, 1070
Hôpital de Jolimont
Haine-Saint-Paul, Hainaut, 7100
Hôpital de Lobbes
Lobbes, Hainaut, 6540
Hôpital de Mons
Mons, Hainaut, 7000
About this study
Official title: Burnout, Emotional Distress and Needs in Frontline COVID-19 Healthcare Workers: Cross-sectional Study in a Belgian Population
Background: In the Covid-19 pandemic context, all healthcare teams face clinical, organizational and technical challenges given the contagion, severity and mortality characteristics of the disease. A study reported the negative psychological impact on healthcare workers of this new situation, in terms of depression, anxiety and distress. Working in frontline constitutes an independent risk factor for worse mental health outcomes.
Methods: This is a cross-sectional study aiming to compare levels of burnout, emotional distress and needs between frontline Covid-19 and non-Covid-19 healthcare workers. Any physician, nurse and physiotherapist will be recruited from emergency care units and Covid-19 care units (target group) and from non-Covid-19 care units (control group) from different hospitals in Belgium. The participation will occur on a voluntary basis. Participants will be recruited from April 15th 2020 to May 15th 2020. Participants will complete self-reported questionnaires and scales. A mixed-mode data collection will be carried out, either in paper or web-based form. This mixed-mode survey will ensure the highest range of participants, considering the hygiene and organizational requirements for target care units. Assessment will provide socio-demographic characteristics and professional information. It will also measure professional fulfillment and burnout with the Stanford Professional Fulfillment Index (PFI), emotional distress with the Depression, Anxiety and Distress Scale-Short Form (DASS-21), sleep disturbance with the Insomnia Severity Index (ISI) and needs with the Needs and Difficulties Inventory (developed for the study).
Read more
Hypothesis: This study is based on the hypothesis that higher levels of burnout, depression, anxiety and stress will be found in frontline Covid-19 healthcare workers than in non-Covid-19 healthcare workers. Considering the unprecedented challenges for healthcare workers and organizations, and considering the exploratory nature of the study, no hypothesis is made for the needs of the healthcare workers.
Statistical Analysis: Means and standard deviation will be calculated for the PFI, the DASS-21, the ISI and the NDI. Multivariate Analysis of Variance (MANOVA) will be performed including the PFI, the DASS-21 and the ISI scores to test the effect of group (work position), occupation and the two-way group × occupation interaction effect. Age, gender, profession, sector of activity, job status and job experience will be entered as covariate. Odds ratio will be also provided. All tests are two-tailed and alpha is set at .05. All analyzes will be performed using IBM SPSS®, version 26.
Read the detailed description
This is a cross-sectional comparative study based on self-reported questionnaires and scales (validated for the most part) assessing the levels of burnout, emotional distress, sleep disturbance and needs in frontline Covid-19 healthcare workers vs non-Covid-19 healthcare workers. The enrollment and the course of the study will be carried out on site. Participants are volunteers and are informed about the objectives and methods of the study.
Any physician, nurse or physiotherapist (referred as "healthcare worker") actively working in a medical care unit from different medical facilities will be informed of the study. An email containing information regarding the study and its implications will be sent. If required by the care unit they work in, potential participants will also be invited to a one-time information session. Potential participants will also be given an information form during this oral information session. Participants will be recruited from April 15th to May 15th 2020.
The assessment will be proposed by paper or web-based self-reported questionnaires and scales. This mixed-mode survey will not be randomized and will ensure the highest range of participants, considering the hygiene and organizational requirements in the target units. The assessment time will be proposed at the participant's inclusion. Because of the mixed-mode survey and anonymity of data, the completion of questionnaires and scales will be considered as informed consent as stated in the information form received by the participants.
The questionnaires and scales include sociodemographic characteristics, professional information, the Professional Fulfillment Index (PFI), the Depression, Anxiety and Stress Scale-Short Form (DASS-21), the Insomnia Severity Index (ISI) and the Needs and Difficulties Inventory (NDI, developed for the study).
Healthcare workers from emergency units, non-intensive Covid-19 and intensive Covid-19 units will be in the target group. Healthcare workers from non-Covid-19 units will be in the control group. In terms of enrollment, 200 participants (100 in each group) are expected. The objectives of the study will be reached by statistical comparison of these groups.
In terms of data collection, the data manager collects data from paper version and electronic version. For the paper version, participants will be able to deposit their assessment in specific drop boxes available in the concerned care units. Then, data manager's assistant will be in charge of producing a digital copy. The data from the paper version will undergo double encoding (by two assistants, not linked to the principal investigator) in order to reduce encoding errors. The electronic data will be stored on a secure platform, linked to the Free University of Brussels. The paper version will be stored in a secure location within Erasme Hospital (Brussels, Belgium), accessible only by the principal investigator and the data manager. Evaluations, whether paper or electronic, will be destroyed 1 month after study completion date.
Statistical analysis will consist firstly in a comparative analysis of participants' sociodemographic and professional characteristics using Chi-squared (or Student t test, Mann-Whitney U test when applicable for continuous variable) test for each categorical variable. Secondly, descriptive analyses will be performed on severity categories for professional fulfillment, burnout, insomnia, depression, anxiety and stress. Differences between groups regarding severity levels will be tested using X2. A two-way MANOVA will be used to test main effects of working position (group effect), occupation type (occupation effect) and to test a group × occupation interaction effect on fulfillment, burnout, insomnia and mental health scores. The two-way MANOVA will be adjusted for age, gender, marital status, workload and job status. Multivariable logistic regression analyses will be performed to estimate risk factors for burnout, clinically significant insomnia and severe to extremely severe depression, anxiety and stress. These will be presented as odds ratios, with 95% confidence intervals, adjusting for confounders. All tests will be two-tailed and alpha was set at .05. All analyses will be performed using IBM SPSS® v26.
- Conditions
- COVID-19
- Keywords
- COVID-19, Healthcare workers burn out, Healthcare workers emotional distress, Healthcare workers needs
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Target Group | This group includes frontline healthcare workers who are actively involved in the management of the Covid-19 outbreak: from emergency units, non-intensive Covid-19 and intensive Covid-19 units. They will fill self-reported questionnaires and scales upon their inclusion. | |
| Control group | This group includes healthcare workers who are actively involved in usual medical care units, referred in this study as non-Covid-19 units. They will fill same self-reported questionnaires and scales than those filled in the Target group, also upon their inclusion.This group will be the comparator of the Target Group to assess the "frontline Covid-19" condition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Burnout
Measured with the Professional Fulfillment Index (PFI). This is a 16-item scale, divided into 2 sub-scales: professional fulfillment (6 items) and burnout, including professional exhaustion (4 items) and interpersonal disengagement (6 items). Subscales scores are given by the mean of all sub-scale items (professional fulfillment, 0-4; burnout, 0-4). Cut-off scores are set for the fulfillment sub-scale at > 3, significant professional fulfillment and for the burnout sub-scale at > 1.33, significant burnout.
Measured: 1 assessment time, at inclusion
Emotional Distress
Measured with the Depression, Anxiety and Stress Scale-Short Form (DASS-21). This a 21-item scale divided into 3 7-item sub-scales: depression, anxiety and stress. Sub-scales scores are given by the sum of all sub-scale items. The DASS has a 4-point Likert scale. Responses options range from " Never " to " Almost always " (0-3 score range). Only cut-off scores are provided for the original version of the DASS. Sub-scales scores must therefore be multiplied by 2. Cut-off scores for depression are Normal, 0-9; Mild, 10-13; Moderate, 14-20; Severe, 21-27; Extremely severe, 28+. Cut-off scores for anxiety are Normal, 0-7; Mild, 8-9; Moderate, 10-14; Severe, 15-19; Extremely severe, 20+. Cut-off scores for stress are Normal, 0-14; Mild, 15-18; Moderate, 19-25; Severe, 26-33; Extremely severe, 34+.
Measured: 1 assessment time, at inclusion
Insomnia
Measured with the Insomnia Severity Index (ISI). This is a 7-item scale. The ISI has a 5-point Likert scale (0-4 score range). Responses options range from " None " to " Very severe " for items 1a., 1b. and 1c., from " Very satisfied " to " Very dissatisfied " for item 2 and from " None " to " Very much " for items 3,4 and 5. The ISI provides a total score by summing all items scores. Cut-off scores are set for no clinically significant insomnia (0-7), subthreshold insomnia (8-14), moderate clinical insomnia (15-21) and severe clinical insomnia (22-28).
Measured: 1 assessment time, at inclusion
Secondary outcomes (1)
Needs and difficulties in work situations
Measured with the Needs and Difficulties Inventory (developed for the study). This scale has been set up for this study. This is a 17-item scale, divided into 5 sub-scales: information/communication (3 items), practical (4 items), physical (4 items), emotional (4 items) and ethical (2 items). The NDI has a 4-point Likert scale. Responses options range from " Not at all agree " to " Totally agree " (0-3 score range). The NDI provides 5 sub-scales scores by summing all sub-scales items: information/communication, 0-9; practical, 0-12; physical, 0-12; emotional, 0-12 and ethical, 0-6. As a no-validated scale, scores and their treatment will be taken into account with caution. In order to compare sub-scales with each other, each sub-scale score must be divided by its maximum value, providing a coefficient (0-1).
Measured: 1 assessment time, at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start16 Apr 2020
- Primary completion25 May 2020
- Study completion29 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 693 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Libre de Bruxelles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Julien Tiete, Université Libre de Bruxelles
- Investigators
- Julien Tiete, PhD, Principal investigator, Université Libre de Bruxelles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344145
- Sponsor's protocol ID
- PSY-ENCOVID19
- Status last verified
- Sep 2020
- First submitted
- 9 Apr 2020
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Local Ethics Committee has not yet approved the study. No plan has therefore been done for the IPD sharing.
Publications
Vandenbroeck S, Van Gerven E, De Witte H, Vanhaecht K, Godderis L. Burnout in Belgian physicians and nurses. Occup Med (Lond). 2017 Oct 1;67(7):546-554. doi: 10.1093/occmed/kqx126.
PubMed 29016982Shanafelt TD, Boone S, Tan L, Dyrbye LN, Sotile W, Satele D, West CP, Sloan J, Oreskovich MR. Burnout and satisfaction with work-life balance among US physicians relative to the general US population. Arch Intern Med. 2012 Oct 8;172(18):1377-85. doi: 10.1001/archinternmed.2012.3199.
PubMed 22911330Wurm W, Vogel K, Holl A, Ebner C, Bayer D, Morkl S, Szilagyi IS, Hotter E, Kapfhammer HP, Hofmann P. Depression-Burnout Overlap in Physicians. PLoS One. 2016 Mar 1;11(3):e0149913. doi: 10.1371/journal.pone.0149913. eCollection 2016.
PubMed 26930395Aiken LH, Clarke SP, Sloane DM, Sochalski J, Silber JH. Hospital nurse staffing and patient mortality, nurse burnout, and job dissatisfaction. JAMA. 2002 Oct 23-30;288(16):1987-93. doi: 10.1001/jama.288.16.1987.
PubMed 12387650Shanafelt TD, Hasan O, Dyrbye LN, Sinsky C, Satele D, Sloan J, West CP. Changes in Burnout and Satisfaction With Work-Life Balance in Physicians and the General US Working Population Between 2011 and 2014. Mayo Clin Proc. 2015 Dec;90(12):1600-13. doi: 10.1016/j.mayocp.2015.08.023.
PubMed 26653297van der Heijden F, Dillingh G, Bakker A, Prins J. Suicidal thoughts among medical residents with burnout. Arch Suicide Res. 2008;12(4):344-6. doi: 10.1080/13811110802325349.
PubMed 18828037Shanafelt TD, Mungo M, Schmitgen J, Storz KA, Reeves D, Hayes SN, Sloan JA, Swensen SJ, Buskirk SJ. Longitudinal Study Evaluating the Association Between Physician Burnout and Changes in Professional Work Effort. Mayo Clin Proc. 2016 Apr;91(4):422-31. doi: 10.1016/j.mayocp.2016.02.001.
PubMed 27046522West CP, Huschka MM, Novotny PJ, Sloan JA, Kolars JC, Habermann TM, Shanafelt TD. Association of perceived medical errors with resident distress and empathy: a prospective longitudinal study. JAMA. 2006 Sep 6;296(9):1071-8. doi: 10.1001/jama.296.9.1071.
PubMed 16954486West CP, Tan AD, Habermann TM, Sloan JA, Shanafelt TD. Association of resident fatigue and distress with perceived medical errors. JAMA. 2009 Sep 23;302(12):1294-300. doi: 10.1001/jama.2009.1389.
PubMed 19773564Fahrenkopf AM, Sectish TC, Barger LK, Sharek PJ, Lewin D, Chiang VW, Edwards S, Wiedermann BL, Landrigan CP. Rates of medication errors among depressed and burnt out residents: prospective cohort study. BMJ. 2008 Mar 1;336(7642):488-91. doi: 10.1136/bmj.39469.763218.BE. Epub 2008 Feb 7.
PubMed 18258931Linzer M, Visser MR, Oort FJ, Smets EM, McMurray JE, de Haes HC; Society of General Internal Medicine (SGIM) Career Satisfaction Study Group (CSSG). Predicting and preventing physician burnout: results from the United States and the Netherlands. Am J Med. 2001 Aug;111(2):170-5. doi: 10.1016/s0002-9343(01)00814-2. No abstract available.
PubMed 11498074Meo SA, Alhowikan AM, Al-Khlaiwi T, Meo IM, Halepoto DM, Iqbal M, Usmani AM, Hajjar W, Ahmed N. Novel coronavirus 2019-nCoV: prevalence, biological and clinical characteristics comparison with SARS-CoV and MERS-CoV. Eur Rev Med Pharmacol Sci. 2020 Feb;24(4):2012-2019. doi: 10.26355/eurrev_202002_20379.
PubMed 32141570Cook TM, El-Boghdadly K, McGuire B, McNarry AF, Patel A, Higgs A. Consensus guidelines for managing the airway in patients with COVID-19: Guidelines from the Difficult Airway Society, the Association of Anaesthetists the Intensive Care Society, the Faculty of Intensive Care Medicine and the Royal College of Anaesthetists. Anaesthesia. 2020 Jun;75(6):785-799. doi: 10.1111/anae.15054. Epub 2020 Apr 1.
PubMed 32221970Wu YC, Chen CS, Chan YJ. The outbreak of COVID-19: An overview. J Chin Med Assoc. 2020 Mar;83(3):217-220. doi: 10.1097/JCMA.0000000000000270.
PubMed 32134861Lai J, Ma S, Wang Y, Cai Z, Hu J, Wei N, Wu J, Du H, Chen T, Li R, Tan H, Kang L, Yao L, Huang M, Wang H, Wang G, Liu Z, Hu S. Factors Associated With Mental Health Outcomes Among Health Care Workers Exposed to Coronavirus Disease 2019. JAMA Netw Open. 2020 Mar 2;3(3):e203976. doi: 10.1001/jamanetworkopen.2020.3976.
PubMed 32202646
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burnout, Emotional Distress and Needs in Frontline COVID-19 Healthcare Workers: Cross-sectional Study in a Belgian Population
- ClinicalTrials.gov ID
- NCT04344145
- Acronym / sponsor ID
- PSY-ENCOVID19
- Conditions
- COVID-19
- Keywords
- COVID-19, Healthcare workers burn out, Healthcare workers emotional distress, Healthcare workers needs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 693 participants (actual)
- Lead sponsor
- Université Libre de BruxellesUniversity, hospital or other
- Study start
- 16 Apr 2020 (actual)
- Primary completion
- 25 May 2020 (actual)
- Study completion
- 29 May 2020 (actual)
- First posted
- 14 Apr 2020 (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.
Background: In the Covid-19 pandemic context, all healthcare teams face clinical, organizational and technical challenges given the contagion, severity and mortality characteristics of the disease. A study reported the negative psychological impact on healthcare workers of this new situation, in terms of depression, anxiety and distress. Working in frontline constitutes an independent risk factor for worse mental health outcomes.
Methods: This is a cross-sectional study aiming to compare levels of burnout, emotional distress and needs between frontline Covid-19 and non-Covid-19 healthcare workers. Any physician, nurse and physiotherapist will be recruited from emergency care units and Covid-19 care units (target group) and from non-Covid-19 care units (control group) from different hospitals in Belgium. The participation will occur on a voluntary basis. Participants will be recruited from April 15th 2020 to May 15th 2020. Participants will complete self-reported questionnaires and scales. A mixed-mode data collection will be carried out, either in paper or web-based form. This mixed-mode survey will ensure the highest range of participants, considering the hygiene and organizational requirements for target care units. Assessment will provide socio-demographic characteristics and professional information. It will also measure professional fulfillment and burnout with the Stanford Professional Fulfillment Index (PFI), emotional distress with the Depression, Anxiety and Distress Scale-Short Form (DASS-21), sleep disturbance with the Insomnia Severity Index (ISI) and needs with the Needs and Difficulties Inventory (developed for the study).
Hypothesis: This study is based on the hypothesis that higher levels of burnout, depression, anxiety and stress will be found in frontline Covid-19 healthcare workers than in non-Covid-19 healthcare workers. Considering the unprecedented challenges for healthcare workers and organizations, and considering the exploratory nature of the study, no hypothesis is made for the needs of the healthcare workers.
Statistical Analysis: Means and standard deviation will be calculated for the PFI, the DASS-21, the ISI and the NDI. Multivariate Analysis of Variance (MANOVA) will be performed including the PFI, the DASS-21 and the ISI scores to test the effect of group (work position), occupation and the two-way group × occupation interaction effect. Age, gender, profession, sector of activity, job status and job experience will be entered as covariate. Odds ratio will be also provided. All tests are two-tailed and alpha is set at .05. All analyzes will be performed using IBM SPSS®, version 26.
Detailed description
This is a cross-sectional comparative study based on self-reported questionnaires and scales (validated for the most part) assessing the levels of burnout, emotional distress, sleep disturbance and needs in frontline Covid-19 healthcare workers vs non-Covid-19 healthcare workers. The enrollment and the course of the study will be carried out on site. Participants are volunteers and are informed about the objectives and methods of the study.
Any physician, nurse or physiotherapist (referred as "healthcare worker") actively working in a medical care unit from different medical facilities will be informed of the study. An email containing information regarding the study and its implications will be sent. If required by the care unit they work in, potential participants will also be invited to a one-time information session. Potential participants will also be given an information form during this oral information session. Participants will be recruited from April 15th to May 15th 2020.
The assessment will be proposed by paper or web-based self-reported questionnaires and scales. This mixed-mode survey will not be randomized and will ensure the highest range of participants, considering the hygiene and organizational requirements in the target units. The assessment time will be proposed at the participant's inclusion. Because of the mixed-mode survey and anonymity of data, the completion of questionnaires and scales will be considered as informed consent as stated in the information form received by the participants.
The questionnaires and scales include sociodemographic characteristics, professional information, the Professional Fulfillment Index (PFI), the Depression, Anxiety and Stress Scale-Short Form (DASS-21), the Insomnia Severity Index (ISI) and the Needs and Difficulties Inventory (NDI, developed for the study).
Healthcare workers from emergency units, non-intensive Covid-19 and intensive Covid-19 units will be in the target group. Healthcare workers from non-Covid-19 units will be in the control group. In terms of enrollment, 200 participants (100 in each group) are expected. The objectives of the study will be reached by statistical comparison of these groups.
In terms of data collection, the data manager collects data from paper version and electronic version. For the paper version, participants will be able to deposit their assessment in specific drop boxes available in the concerned care units. Then, data manager's assistant will be in charge of producing a digital copy. The data from the paper version will undergo double encoding (by two assistants, not linked to the principal investigator) in order to reduce encoding errors. The electronic data will be stored on a secure platform, linked to the Free University of Brussels. The paper version will be stored in a secure location within Erasme Hospital (Brussels, Belgium), accessible only by the principal investigator and the data manager. Evaluations, whether paper or electronic, will be destroyed 1 month after study completion date.
Statistical analysis will consist firstly in a comparative analysis of participants' sociodemographic and professional characteristics using Chi-squared (or Student t test, Mann-Whitney U test when applicable for continuous variable) test for each categorical variable. Secondly, descriptive analyses will be performed on severity categories for professional fulfillment, burnout, insomnia, depression, anxiety and stress. Differences between groups regarding severity levels will be tested using X2. A two-way MANOVA will be used to test main effects of working position (group effect), occupation type (occupation effect) and to test a group × occupation interaction effect on fulfillment, burnout, insomnia and mental health scores. The two-way MANOVA will be adjusted for age, gender, marital status, workload and job status. Multivariable logistic regression analyses will be performed to estimate risk factors for burnout, clinically significant insomnia and severe to extremely severe depression, anxiety and stress. These will be presented as odds ratios, with 95% confidence intervals, adjusting for confounders. All tests will be two-tailed and alpha was set at .05. All analyses will be performed using IBM SPSS® v26.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Target Group | – | –This group includes frontline healthcare workers who are actively involved in the management of the Covid-19 outbreak: from emergency units, non-intensive Covid-19 and intensive Covid-19 units. They will fill self-reported questionnaires and scales upon their inclusion. |
| Control group | – | –This group includes healthcare workers who are actively involved in usual medical care units, referred in this study as non-Covid-19 units. They will fill same self-reported questionnaires and scales than those filled in the Target group, also upon their inclusion.This group will be the comparator of the Target Group to assess the "frontline Covid-19" condition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study targets healthcare workers in Belgian hospital. It targets any physician, nurse or physiotherapist in emergency, non-intensive Covid-19 and intensive Covid-19 care unit (target group) and in usual medical care unit (control group). There is no sampling method. Participation is on voluntary basis.
Key inclusion criteria (2 listed)
- Ability to read, speak and write in French;
- Being professionally active (doctor, nurse or physiotherapist) within a medical care unit;
Key exclusion criteria (1 listed)
- Having been off work (for medical, professional or personal reasons) for ≥ 3 weeks before first assessment time.
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
Burnout
Time frame: 1 assessment time, at inclusion
Measured with the Professional Fulfillment Index (PFI). This is a 16-item scale, divided into 2 sub-scales: professional fulfillment (6 items) and burnout, including professional exhaustion (4 items) and interpersonal disengagement (6 items). Subscales scores are given by the mean of all sub-scale items (professional fulfillment, 0-4; burnout, 0-4). Cut-off scores are set for the fulfillment sub-scale at > 3, significant professional fulfillment and for the burnout sub-scale at > 1.33, significant burnout.
Emotional Distress
Time frame: 1 assessment time, at inclusion
Measured with the Depression, Anxiety and Stress Scale-Short Form (DASS-21). This a 21-item scale divided into 3 7-item sub-scales: depression, anxiety and stress. Sub-scales scores are given by the sum of all sub-scale items. The DASS has a 4-point Likert scale. Responses options range from " Never " to " Almost always " (0-3 score range). Only cut-off scores are provided for the original version of the DASS. Sub-scales scores must therefore be multiplied by 2. Cut-off scores for depression are Normal, 0-9; Mild, 10-13; Moderate, 14-20; Severe, 21-27; Extremely severe, 28+. Cut-off scores for anxiety are Normal, 0-7; Mild, 8-9; Moderate, 10-14; Severe, 15-19; Extremely severe, 20+. Cut-off scores for stress are Normal, 0-14; Mild, 15-18; Moderate, 19-25; Severe, 26-33; Extremely severe, 34+.
Insomnia
Time frame: 1 assessment time, at inclusion
Measured with the Insomnia Severity Index (ISI). This is a 7-item scale. The ISI has a 5-point Likert scale (0-4 score range). Responses options range from " None " to " Very severe " for items 1a., 1b. and 1c., from " Very satisfied " to " Very dissatisfied " for item 2 and from " None " to " Very much " for items 3,4 and 5. The ISI provides a total score by summing all items scores. Cut-off scores are set for no clinically significant insomnia (0-7), subthreshold insomnia (8-14), moderate clinical insomnia (15-21) and severe clinical insomnia (22-28).
1 secondary outcome
Needs and difficulties in work situations
Time frame: 1 assessment time, at inclusion
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 9 Sep 2020.
- Results publication: PubMed 29016982Vandenbroeck S, Van Gerven E, De Witte H, Vanhaecht K, Godderis L. Burnout in Belgian physicians and nurses. Occup Med (Lond). 2017 Oct 1;67(7):546-554. doi: 10.1093/occmed/kqx126.
- Results publication: PubMed 22911330Shanafelt TD, Boone S, Tan L, Dyrbye LN, Sotile W, Satele D, West CP, Sloan J, Oreskovich MR. Burnout and satisfaction with work-life balance among US physicians relative to the general US population. Arch Intern Med. 2012 Oct 8;172(18):1377-85. doi: 10.1001/archinternmed.2012.3199.
- Results publication: PubMed 26930395Wurm W, Vogel K, Holl A, Ebner C, Bayer D, Morkl S, Szilagyi IS, Hotter E, Kapfhammer HP, Hofmann P. Depression-Burnout Overlap in Physicians. PLoS One. 2016 Mar 1;11(3):e0149913. doi: 10.1371/journal.pone.0149913. eCollection 2016.
- Results publication: PubMed 12387650Aiken LH, Clarke SP, Sloane DM, Sochalski J, Silber JH. Hospital nurse staffing and patient mortality, nurse burnout, and job dissatisfaction. JAMA. 2002 Oct 23-30;288(16):1987-93. doi: 10.1001/jama.288.16.1987.
- Results publication: PubMed 26653297Shanafelt TD, Hasan O, Dyrbye LN, Sinsky C, Satele D, Sloan J, West CP. Changes in Burnout and Satisfaction With Work-Life Balance in Physicians and the General US Working Population Between 2011 and 2014. Mayo Clin Proc. 2015 Dec;90(12):1600-13. doi: 10.1016/j.mayocp.2015.08.023.
- Results publication: PubMed 18828037van der Heijden F, Dillingh G, Bakker A, Prins J. Suicidal thoughts among medical residents with burnout. Arch Suicide Res. 2008;12(4):344-6. doi: 10.1080/13811110802325349.
- Results publication: PubMed 27046522Shanafelt TD, Mungo M, Schmitgen J, Storz KA, Reeves D, Hayes SN, Sloan JA, Swensen SJ, Buskirk SJ. Longitudinal Study Evaluating the Association Between Physician Burnout and Changes in Professional Work Effort. Mayo Clin Proc. 2016 Apr;91(4):422-31. doi: 10.1016/j.mayocp.2016.02.001.
- Results publication: PubMed 16954486West CP, Huschka MM, Novotny PJ, Sloan JA, Kolars JC, Habermann TM, Shanafelt TD. Association of perceived medical errors with resident distress and empathy: a prospective longitudinal study. JAMA. 2006 Sep 6;296(9):1071-8. doi: 10.1001/jama.296.9.1071.
- Results publication: PubMed 19773564West CP, Tan AD, Habermann TM, Sloan JA, Shanafelt TD. Association of resident fatigue and distress with perceived medical errors. JAMA. 2009 Sep 23;302(12):1294-300. doi: 10.1001/jama.2009.1389.
- Results publication: PubMed 18258931Fahrenkopf AM, Sectish TC, Barger LK, Sharek PJ, Lewin D, Chiang VW, Edwards S, Wiedermann BL, Landrigan CP. Rates of medication errors among depressed and burnt out residents: prospective cohort study. BMJ. 2008 Mar 1;336(7642):488-91. doi: 10.1136/bmj.39469.763218.BE. Epub 2008 Feb 7.
- Results publication: PubMed 11498074Linzer M, Visser MR, Oort FJ, Smets EM, McMurray JE, de Haes HC; Society of General Internal Medicine (SGIM) Career Satisfaction Study Group (CSSG). Predicting and preventing physician burnout: results from the United States and the Netherlands. Am J Med. 2001 Aug;111(2):170-5. doi: 10.1016/s0002-9343(01)00814-2. No abstract available.
- Results publication: PubMed 32141570Meo SA, Alhowikan AM, Al-Khlaiwi T, Meo IM, Halepoto DM, Iqbal M, Usmani AM, Hajjar W, Ahmed N. Novel coronavirus 2019-nCoV: prevalence, biological and clinical characteristics comparison with SARS-CoV and MERS-CoV. Eur Rev Med Pharmacol Sci. 2020 Feb;24(4):2012-2019. doi: 10.26355/eurrev_202002_20379.
- Individual participant dataSharing planned: Undecided. Local Ethics Committee has not yet approved the study. No plan has therefore been done for the IPD sharing.
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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.
Julien Tiete, PhD principal investigator
Université Libre de Bruxelles
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Université Libre de Bruxelles at 5 sites in Belgium.
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 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 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium. 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?
Burnout (time frame: 1 assessment time, at inclusion). 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?
On the ClinicalTrials.gov record for NCT04344145, which also lists 20 linked publications.
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 9 Sep 2020.