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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05054608
• Other study ID #: U1111-1269-5745
• Status: Completed
• Start date: October 15, 2021
• Est. completion date: November 15, 2021

Study information

• Verified date: November 2022
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13537
• Est. completion date: November 15, 2021
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 63 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Other:
• No intervention
Observational study. No intervention.

Locations

Country	Name	City	State
Sweden	Uppsala University	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University	Dalarna County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Is group an independent risk factor for having one or more additional sick leave free days alive? Ordinal logistic model including variables below.	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).	One year
Secondary	Is cohort an independent risk factor for being on sick leave one year after inclusion? Binary logistic model containing the variables below?	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).	One year