We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The COVID-ICU Healthcare Professional Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04372056
Recruitment Status : Completed
First Posted : May 1, 2020
Last Update Posted : November 23, 2021
Sponsor:
Information provided by (Responsible Party):
Irene Lie, Oslo University Hospital

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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 experiences of Health care professionals. Leaders at the randomized hospitals will be asked to participate in individualized interviews.

Condition or disease Intervention/treatment
COVID-19 Critical Care Intensive Care Units Health Personnel Behavioral: Views and experiences of health care professionals working in intensive care units during the COVID-19 pandemic

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 484 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Norwegian Study on Views and Experiences of Health Care Professionals Working in Intensive Care Units During the COVID-19 Pandemic.
Actual Study Start Date : May 6, 2020
Actual Primary Completion Date : June 4, 2021
Actual Study Completion Date : June 4, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Behavioral: Views and experiences of health care professionals working in intensive care units during the COVID-19 pandemic
    Health care professionals
    Other Name: COVID-ICU Health Care Professionals

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

Criteria

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

Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04372056


Locations
Layout table for location information
Norway
Oslo university hospital
Oslo, Norway
Sponsors and Collaborators
Oslo University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Irene Lie, PhD Oslo University Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Irene Lie, Principal investigator, RN, CCN,PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT04372056    
Other Study ID Numbers: 136144
First Posted: May 1, 2020    Key Record Dates
Last Update Posted: November 23, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases