Clinical trial NCT05054608: Long Term Outcome in ICU Treated COVID-19: Return to Work
Official title: Long Term Outcome in ICU Treated COVID-19: Return to Work
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: Long term outcome
Return to work
COVID-19
Risk factors
Critical care
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Dalarna County Council, Sweden
First posted: 2021-09-23
Enrollment: 13537
Sex: ALL
Minimum age (years): 18
Maximum age (years): 63
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consists of all patients a fulfilling the eligibility criteria.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Is group an independent risk factor for having one or more additional sick leave free days alive? Ordinal logistic model including variables below.
timeFrame: One year
Secondary outcomes:
measure: Is cohort an independent risk factor for being on sick leave one year after inclusion? Binary logistic model containing the variables below?
timeFrame: One year
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University
Study officials:
affiliation: Uppsala University
name: Miklos Lipcsey, Professor
role: PRINCIPAL_INVESTIGATOR
References: