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OpenTrials
Completed

NCT Number: NCT05054608

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

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.

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Key information

Age range

18 year–63 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Uppsala University

Uppsala, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

Observational study. No intervention.

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.

    Time frame: 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 outcomes

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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Dalarna County Council, Sweden

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 23, 2021
Registry last updated
Dec 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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