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Survival Rates and Longterm Outcomes After COVID-19

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ClinicalTrials.gov Identifier: NCT04601090
Recruitment Status : Recruiting
First Posted : October 23, 2020
Last Update Posted : October 26, 2020
Sponsor:
Collaborator:
The Research Council of Norway
Information provided by (Responsible Party):
Kristin Hofsø, Oslo University Hospital

Brief Summary:
The study 'Survival rates and long-term outcomes for patients with COVID-19 admitted to Norwegian ICUs' is a national observational study, including patients admitted to a Norwegian ICU between March 2020 and March 2021. The study will describe survival rates, clinical characteristics and health challenges experienced by survivors the first year after ICU admission caused by COVID-19 disease.

Condition or disease Intervention/treatment
Covid19 Acute Respiratory Failure Acute Respiratory Distress Syndrome Post Intensive Care Unit Syndrome Survivorship Other: ICU treatment

Detailed Description:
The study 'Survival rates and long-term outcomes for patients with COVID-19 admitted to Norwegian ICUS' has two different aims. The first aim is to synthesis data from a National register (Norwegian Intensive care register-NIR) on all COVID-19 patients in Norway admitted to an ICU. These results are of great public interest for many reasons. First of all, it will give us information on the severity of this novel virus, but also how the health care system has coped in treating the severe cases that was admitted to an ICU. The results will potentially be compared to other patient populations with viral pneumonia, but most interestingly to survival rates from other countries. In addition, the data will give us a description on how the distribution of severe cases of COVID-19 have been within Norway (e.g., gender, age, health regions etc.) The second aim of this study is to measure and describe health related challenges COVID-19 patients may experience during their first year from ICU admission. The health-related domains that will be investigated will capture both mental, physical and cognitive health. Knowledge from other patient population admitted to an ICU with acute respiratory failure, indicates that these are the main domains that negatively affect the activity of daily living. Physical, mental and cognitive health challenges will be investigated for the Norwegian COVID -19 population admitted to ICU, and will give important insight to the impact COVID-19 can have on survivors of severe cases, as well as the need for rehabilitation.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Survival Rates and Long-term Outcomes for Patients With COVID-19 Admitted to Norwegian ICUs
Actual Study Start Date : September 16, 2020
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022



Intervention Details:
  • Other: ICU treatment
    This is an observational study, so all patients will undergo a variation of ICU treatment, and we will record that information (e.g., time on ventilator, time in ICU, SAPS score at admission)


Primary Outcome Measures :
  1. ICU Survival rate [ Time Frame: up to 30 days ]
    Time to survival

  2. Change in Functional Status [ Time Frame: 6 and 12 months after ICU admission ]
    Measured by self-reporting using Lawton Instrumental activity of daily living. Higher score indicates better function, and ranges from 0-8.


Secondary Outcome Measures :
  1. Change in Anxiety and Depression [ Time Frame: Measured 6 and 12 months after ICU admission ]
    Measured by self-report using Hospital Anxiety and Depression Scale (HADS). Higher score indicates higher lever of anxiety and depression, scored on separate sub scales (0-21 for each).

  2. Changes in Cognitive Status [ Time Frame: Measured at 6 and 12 months after ICU admission ]
    Measured by telephone interview using the Mini Montreal Cognitive Assessment, score ranges from 0-15. Higher score indicates better cognitive function.

  3. Change in Quality of Life 6 and 12 months after ICU admission [ Time Frame: Measured 6 and 12 months after ICU admission ]
    Measured by self report using (Euroqual 5 dimensions) EQ-5D. Higher score indicates worse health (range 5-15).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients that have been admitted to a Norwegian ICU with confirmed COVID-19, and not reserved them against the national register, will be contacted for inclusion to the study.
Criteria

Inclusion Criteria:

  • Patients registered in Norwegian Intensive Care Register, that are ≥ 18 years with confirmed cases of COVID-19.

Exclusion Criteria:

  • Exclusion criteria only for follow-up study: Do not understand Norwegian.

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): NCT04601090


Contacts
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Contact: Kristin Hofsø, PhD +4799544509 kristin.hofso@ldh.no

Locations
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Norway
Oslo University Hospital Recruiting
Oslo, Norway, 0027
Contact: Kristin Hofsø, PhD    +4799544509    kristin.hofso@ldh.no   
Sponsors and Collaborators
Oslo University Hospital
The Research Council of Norway
Investigators
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Principal Investigator: Kristin Hofsø, PhD Oslo University Hospital
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Responsible Party: Kristin Hofsø, PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT04601090    
Other Study ID Numbers: 135310
First Posted: October 23, 2020    Key Record Dates
Last Update Posted: October 26, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kristin Hofsø, Oslo University Hospital:
ICU treatment
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury