- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04372056
The COVID-ICU Healthcare Professional Study
A Norwegian Study on Views and Experiences of Health Care Professionals Working in Intensive Care Units During the COVID-19 Pandemic.
Study Overview
Status
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Oslo, Norway
- Oslo University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
Inclusion Criteria:
All health care professionals (nurses, medical doctors, leaders) working in all COVID-ICUs in Norway will be invited to participate in this project.
Exclusion Criteria:
No exclusion criteria
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Views and experiences of health care professionals working in intensive care units during the COVID-19 pandemic
Time Frame: 1 year
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Health care professionals working in COVID-ICUs
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1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Irene Lie, PhD, Oslo University Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 136144
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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