COVID-19NCT04372056
The COVID-ICU Healthcare Professional Study
An observational study of COVID-19 and Critical Care, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The project is a longitudinal cohort study based on an electronic questionnaire on views and experiences of COVID-ICU Health care professionals during the pandemic. In addition, a few of the informants participating in the cohort study will be asked to participate in focus groups to get a deeper understanding of the… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Critical Care, Intensive Care Units
- What is being tested?
- Views and experiences of health care professionals working in intensive care units during the COVID-19 pandemic
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 484 participants
- Where
- 1 siteNorway
- Study dates
- 6 May 2020to 4 Jun 2021
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The longitudinal cohort study will collect data from all consenting health care professionals in COVID-ICUs in Norway during the pandemic with 3- and 12-months follow-up on a combined electronic consent form and questionnaire that the informants will fill in using a computer and an electronic identification. A few of the informants (medical doctors, nurses, leaders) participating in the cohort study will randomly (computerized) be asked to participate in focus groups during the 12-months study follow-up. Leaders at the randomized hospitals will be asked to participate in individualized interviews.
Who may be able to join
- All health care professionals (nurses, medical doctors, leaders) working in all COVID-ICUs in Norway will be invited to participate in this project.
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Norwegian Study on Views and Experiences of Health Care Professionals Working in Intensive Care Units During the COVID-19 Pandemic.
The project is a longitudinal cohort study based on an electronic questionnaire on views and experiences of COVID-ICU Health care professionals during the pandemic. In addition, a few of the informants participating in the cohort study will be asked to participate in focus groups to get a deeper understanding of the experiences of Health care professionals. Leaders at the randomized hospitals will be asked to participate in individualized interviews.
Read the detailed description
Health Care professionals in intensive care units (ICU) are working front-line with coronavirus disease (COVID-19) patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in need of intensive care treatment.
Data collected will identify the health care professionals' (nurses, medical doctors, leaders) views and experiences from the planning period of COVID-19 ICU units until a follow-up at 12 months.Themes to be covered in the survey are organization, information, communication across disciplines, education, practical implementation, use of personal protective equipment, daily working conditions and psychosocial aspects. The Oslo University Hospital/University of Oslo, GDPR (General Data Protection Regulation) compliant "TSD"-Services for Sensitive data web-based solution "Nettskjema" will be used combined for consent form and data collection from the survey. It is within the scope of the study to perform sub analysis on background variables as profession related to daily working experiences on COVID-ICU and psychosocial aspects.
A few of the informants (medical doctors, nurses, leaders) participating in the cohort study will randomly (computerized) be asked to participate in focus groups to get a deeper understanding of the experiences of the health care professionals during the pandemic and after the pandemic when they are back to a normal working condition. Leaders at the randomized hospitals will be asked to participate in individualized interviews. Data from the focus group interviews and individual interviews will be taped on a recorder approved by data protection officer at Oslo University Hospital and then stored at a secured computerized research place at Oslo University Hospital.
The gained knowledge from both the survey, the focus group interviews and individual interviews in this study may guide hospital directors and the government in follow up of health care professionals and to prepare for a later pandemic.
- Conditions
- COVID-19, Critical Care, Intensive Care Units, Health Personnel
- Being tested
- Views and experiences of health care professionals working in intensive care units during the COVID-19 pandemic
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Views and experiences of health care professionals working in intensive care units during the COVID-19 pandemicBehavioural
Also called COVID-ICU Health Care Professionals
Health care professionals
What is being measured
The primary outcome is the main question the study is designed to answer.
Views and experiences of health care professionals working in intensive care units during the COVID-19 pandemic
Health care professionals working in COVID-ICUs
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start6 May 2020
- Primary completion4 Jun 2021
- Study completion4 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- 484 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irene Lie, Oslo University Hospital
- Investigators
- Irene Lie, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372056
- Sponsor's protocol ID
- 136144
- Status last verified
- Nov 2021
- First submitted
- 29 Apr 2020
- Last updated
- 23 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hovland IS, Skogstad L, Stafseth S, Hem E, Diep LM, Raeder J, Ekeberg O, Lie I. Prevalence of psychological distress in nurses, physicians and leaders working in intensive care units during the COVID-19 pandemic: a national one-year follow-up study. BMJ Open. 2023 Dec 22;13(12):e075190. doi: 10.1136/bmjopen-2023-075190.
PubMed 38135308Lie I, Stafseth S, Skogstad L, Hovland IS, Hovde H, Ekeberg O, Raeder J. Healthcare professionals in COVID-19-intensive care units in Norway: preparedness and working conditions: a cohort study. BMJ Open. 2021 Oct 11;11(10):e049135. doi: 10.1136/bmjopen-2021-049135.
PubMed 34635518
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Norwegian Study on Views and Experiences of Health Care Professionals Working in Intensive Care Units During the COVID-19 Pandemic.
- ClinicalTrials.gov ID
- NCT04372056
- Acronym / sponsor ID
- 136144
- Conditions
- COVID-19, Critical Care, Intensive Care Units, Health Personnel
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 484 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 6 May 2020 (actual)
- Primary completion
- 4 Jun 2021 (actual)
- Study completion
- 4 Jun 2021 (actual)
- First posted
- 1 May 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.
The project is a longitudinal cohort study based on an electronic questionnaire on views and experiences of COVID-ICU Health care professionals during the pandemic. In addition, a few of the informants participating in the cohort study will be asked to participate in focus groups to get a deeper understanding of the experiences of Health care professionals. Leaders at the randomized hospitals will be asked to participate in individualized interviews.
Detailed description
Health Care professionals in intensive care units (ICU) are working front-line with coronavirus disease (COVID-19) patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in need of intensive care treatment.
Data collected will identify the health care professionals' (nurses, medical doctors, leaders) views and experiences from the planning period of COVID-19 ICU units until a follow-up at 12 months.Themes to be covered in the survey are organization, information, communication across disciplines, education, practical implementation, use of personal protective equipment, daily working conditions and psychosocial aspects. The Oslo University Hospital/University of Oslo, GDPR (General Data Protection Regulation) compliant "TSD"-Services for Sensitive data web-based solution "Nettskjema" will be used combined for consent form and data collection from the survey. It is within the scope of the study to perform sub analysis on background variables as profession related to daily working experiences on COVID-ICU and psychosocial aspects.
A few of the informants (medical doctors, nurses, leaders) participating in the cohort study will randomly (computerized) be asked to participate in focus groups to get a deeper understanding of the experiences of the health care professionals during the pandemic and after the pandemic when they are back to a normal working condition. Leaders at the randomized hospitals will be asked to participate in individualized interviews. Data from the focus group interviews and individual interviews will be taped on a recorder approved by data protection officer at Oslo University Hospital and then stored at a secured computerized research place at Oslo University Hospital.
The gained knowledge from both the survey, the focus group interviews and individual interviews in this study may guide hospital directors and the government in follow up of health care professionals and to prepare for a later pandemic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The longitudinal cohort study will collect data from all consenting health care professionals in COVID-ICUs in Norway during the pandemic with 3- and 12-months follow-up on a combined electronic consent form and questionnaire that the informants will fill in using a computer and an electronic identification. A few of the informants (medical doctors, nurses, leaders) participating in the cohort study will randomly (computerized) be asked to participate in focus groups during the 12-months study follow-up. Leaders at the randomized hospitals will be asked to participate in individualized interviews.
Key inclusion criteria (1 listed)
- All health care professionals (nurses, medical doctors, leaders) working in all COVID-ICUs in Norway will be invited to participate in this project.
Key exclusion criteria (1 listed)
- No exclusion criteria
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 |
|---|---|---|
| Views and experiences of health care professionals working in intensive care units during the COVID-19 pandemicAlso: COVID-ICU Health Care ProfessionalsHealth care professionals | Behavioural | – |
Primary outcome
Views and experiences of health care professionals working in intensive care units during the COVID-19 pandemic
Time frame: 1 year
Health care professionals working in COVID-ICUs
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 Nov 2021.
- Derived from this study: PubMed 38135308Hovland IS, Skogstad L, Stafseth S, Hem E, Diep LM, Raeder J, Ekeberg O, Lie I. Prevalence of psychological distress in nurses, physicians and leaders working in intensive care units during the COVID-19 pandemic: a national one-year follow-up study. BMJ Open. 2023 Dec 22;13(12):e075190. doi: 10.1136/bmjopen-2023-075190.
- Derived from this study: PubMed 34635518Lie I, Stafseth S, Skogstad L, Hovland IS, Hovde H, Ekeberg O, Raeder J. Healthcare professionals in COVID-19-intensive care units in Norway: preparedness and working conditions: a cohort study. BMJ Open. 2021 Oct 11;11(10):e049135. doi: 10.1136/bmjopen-2021-049135.
- 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.
Irene Lie, PhD principal investigator
Oslo University Hospital
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 COVID-19 and Critical Care, run by Oslo University Hospital at 1 site in Norway.
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 23 Nov 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 Norway. 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?
Views and experiences of health care professionals working in intensive care units during the COVID-19 pandemic (time frame: 1 year). 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 NCT04372056, which also lists 2 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 23 Nov 2021; AzTrials last refreshed its copy on 6 Nov 2026.