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

NCT05054608 | Completed

• 1 other identifier: U1111-1269-5745
• Study Type: observational
• Target: 13,537
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

Long term outcome; Return to work; COVID-19; Risk factors; Critical care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Is cohort an independent risk factor for being on sick leave one year after inclusion? Binary logistic model containing the variables below?

  One year

Study Arms (3)

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

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

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

Interventions

No intervention OTHER

Observational study. No intervention.

COVID-19 ICU cohort; COVID-19 hospital admission control cohort; General population control cohort

Eligibility Criteria

• Age: 18 Years - 63 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study population consists of all patients a fulfilling the eligibility criteria.

You may qualify if:

• 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

Sponsors & Collaborators

• Uppsala University: lead
• Dalarna County Council, Sweden: collaborator

Study Sites (1)

Uppsala University

Uppsala, Sweden

Location

Related Publications (1)

• Ahlstrom B, Frithiof R, Marks-Hultstrom M, Larsson IM, Strandberg G, Lipcsey M. The 1-Year Functional Recovery From Severe COVID-19 in a Swedish Working-Age Cohort. Acta Anaesthesiol Scand. 2025 Jul;69(6):e70058. doi: 10.1111/aas.70058.

  PMID: 40356220 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Miklos Lipcsey, Professor

  Uppsala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: September 23, 2021
• Study Start: October 15, 2021
• Primary Completion: November 15, 2021
• Study Completion: November 15, 2021
• Last Updated: December 5, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)