Long Term Outcome in ICU Treated COVID-19: Return to Work

Sponsor
Uppsala University (Other)
Overall Status
Completed
CT.gov ID
NCT05054608
Collaborator
Dalarna County Council, Sweden (Other)
13,537
1
1
13291.4

Study Details

Study Description

Brief Summary

Return to work (not being on sick leave) within one year after intensive care unit (ICU) admission with Coronavirus disease 2019 (COVID-19) will be assessed. Risk and risk factors for not having returned to work will be compared to patients admitted to hospital and general population controls.

The ICU population comprises all Swedish ICU patients with COVID-19 with at least one year of follow up. The hospital admitted cohort comprises four hospital admitted patients with COVID-19 per ICU patient, matched on age, legal gender and region. The general population controls are matched to the ICU patients in a one to four fashion on age, legal gender and region.

ICU patients are identified in the Swedish intensive care registry. The hospital admitted patients are identified in the national patient registry and the population controls are identified in the population registry. Data on socioeconomics and income are provided by the Statistics Sweden. Data on comorbidity, medications and death are provided from the National board of health and welfare. Finally, data on sick leave are provided from the Swedish Social Insurance Agency.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

Study Design

Study Type:
Observational
Actual Enrollment :
13537 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Long Term Outcome in ICU Treated COVID-19: Return to Work
Actual Study Start Date :
Oct 15, 2021
Actual Primary Completion Date :
Nov 15, 2021
Actual Study Completion Date :
Nov 15, 2021

Arms and Interventions

Arm Intervention/Treatment
COVID-19 ICU cohort

All patients, 18 to 63 years old, admitted to a Swedish ICU with COVID-19 with at least one year of follow up. COVID-19 defined by the ICD-10 diagnosis U07.1 in the nationwide Swedish intensive care registry.

Other: No intervention
Observational study. No intervention.

COVID-19 hospital admission control cohort

Four random control patients per ICU patient matched on age legal gender and region. Controls selected from all patients admitted to a Swedish hospital with COVID-19 with at least one year of follow up. Not including patients in the COVID-19 ICU cohort. COVID-19 defined by the ICD-10 diagnosis U07.1 in the nationwide Swedish national patient registry.

Other: No intervention
Observational study. No intervention.

General population control cohort

Four general population controls per ICU patient, matched on age, legal gender and region drawn from the total population register of Sweden. Not including ICU and hospital admitted COVID-19 patients.

Other: No intervention
Observational study. No intervention.

Outcome Measures

Primary Outcome Measures

  1. Is cohort an independent risk factor for being on sick leave one year after inclusion in a logistic model containing the variables below? [One year]

    Variables in binary logistic model: On sick leave one year before ICU admission, age, legal gender, highest education, immigrant background, income the year before inclusion, marital status, cohort (ICU, Hospital or General population).

  2. Does the impact of the variables below differ between cohorts on the risk for being on sick leave one year after inclusion? [One year]

    Variables in binary logistic model: On sick leave one year before ICU admission, age, legal gender, highest education, immigrant background, income the year before inclusion, marital status. Interaction with a variable denoting cohort (ICU, Hospital or General population) is added to all variables. A significant interaction indicates a differential effect between cohorts.

Secondary Outcome Measures

  1. Is cohort an independent risk factor for being on sick leave one year after inclusion in a linear regression model containing the variables below? [One year]

    Variables in linear regression model: On sick leave one year before ICU admission, age, legal gender, highest education, immigrant background, income the year before inclusion, marital status, cohort (ICU, Hospital or General population).

  2. Does the impact of the variables below differ between cohorts on the number of sick leave free days one year after inclusion? [One year]

    Variables in linear regression model: On sick leave one year before ICU admission, age, legal gender, highest education, immigrant background, income the year before inclusion, marital status. Interaction with a variable denoting cohort (ICU, Hospital or General population) is added to all variables. A significant interaction indicates a differential effect between cohorts.

  3. Does the main diagnoses on the medical certificate associated with sick leave one year after inclusion distribute differently among cohorts? [One year]

    Distribution of diagnoses grouped by International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10), Chi square test.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 63 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

Admitted to a Swedish ICU and registered in the Swedish intensive care registry with the ICD 10 diagnosis U07.1 before 1 July 2020. ICU-cohort.

or randomly selected from all patients admitted to hospital but not ICU with the ICD 10 diagnosis U07.1 in the national patient registry, matched on age, legal gender and region (four per ICU patient) before 1 July 2020. Hospital cohort.

or randomly selected from the general population (and not included in the ICU or hospital admitted cohorts), matched on age, legal gender and region (four per ICU patient)

Exclusion Criteria:

Death within one year of inclusion. Missing a Swedish personal identification number

Contacts and Locations

Locations

Site City State Country Postal Code
1 Uppsala University Uppsala Sweden

Sponsors and Collaborators

  • Uppsala University
  • Dalarna County Council, Sweden

Investigators

  • Principal Investigator: Miklos Lipcsey, Professor, Uppsala University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Uppsala University
ClinicalTrials.gov Identifier:
NCT05054608
Other Study ID Numbers:
  • U1111-1269-5745
First Posted:
Sep 23, 2021
Last Update Posted:
May 24, 2022
Last Verified:
May 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 Uppsala University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 24, 2022