Survival Rates and Longterm Outcomes After COVID-19

Sponsor
Oslo University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04601090
Collaborator
The Research Council of Norway (Other)
860
1
21.7
39.5

Study Details

Study Description

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 Phase
  • 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.

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
860 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Survival Rates and Long-term Outcomes for Patients With COVID-19 Admitted to Norwegian ICUs
Actual Study Start Date :
Sep 16, 2020
Actual Primary Completion Date :
Jun 30, 2021
Actual Study Completion Date :
Jul 10, 2022

Outcome Measures

Primary Outcome Measures

  1. ICU Survival rate [up to 30 days]

    Time to survival

  2. Change in Functional Status [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 [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 [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 [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Oslo University Hospital Oslo Norway 0027

Sponsors and Collaborators

  • Oslo University Hospital
  • The Research Council of Norway

Investigators

  • Principal Investigator: Kristin Hofsø, PhD, Oslo University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kristin Hofsø, PhD, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT04601090
Other Study ID Numbers:
  • 135310
First Posted:
Oct 23, 2020
Last Update Posted:
Jul 15, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kristin Hofsø, PhD, Oslo University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 15, 2022