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

Completed

• Conditions: Covid19
• Interventions: Other: No intervention

• Registration Number: NCT05054608
• Lead Sponsor: Uppsala University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-20
• Study First Submitted QC: 2021-09-21
• Study First Posted: 2021-09-23
• Study Start: 2021-10-15
• Primary Completion: 2021-11-15
• Study Completion: 2021-11-15
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-30
• Last Update Posted: 2022-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13537

Inclusion Criteria

Admitted to a Swedish ICU and registered in the Swedish intensive care registry with the ICD 10 diagnosis U07.1 before 31 July 2020. ICU group.

or Admitted to hospital but not ICU with the ICD-10 diagnosis U07.1 in the national patient registry before 31 July 2020. Hospital group.

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). Population control group

Exclusion Criteria

Death within one year of inclusion. (For analysis of the secondary outcome). Missing a Swedish personal identification number

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID-19 ICU cohort	No intervention	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.
General population control cohort	No intervention	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.
COVID-19 hospital admission control cohort	No intervention	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.

Primary Outcome Measures

Name	Time	Method
Is group an independent risk factor for having one or more additional sick leave free days alive? Ordinal logistic model including variables below.	One year	Variables in binary logistic model: On sick leave one year before ICU admission, Charlson comorbidity index, age, legal gender, highest education, immigrant background, income the year before inclusion, marital status, group (ICU, Hospital or General population).

Secondary Outcome Measures

Name	Time	Method
Is cohort an independent risk factor for being on sick leave one year after inclusion? Binary logistic model containing the variables below?	One year	Variables in linear regression model: On sick leave one year before ICU admission, Charlson comorbidity index, age, legal gender, highest education, immigrant background, income the year before inclusion, marital status, group (ICU, Hospital or General population).

Trial Locations

Locations (1)

Uppsala University; 🇸🇪 Uppsala, Sweden