Long-term Cognitive and Functional Status After COVID-19 Treatment at Danish ICUs

Study Overview
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Brief Summary
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This study is a prospective observational cohort study of 6 and 12 months long-term outcome of Danish speaking patients with COVID-19.

Detailed Description
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To describe frailty, cognitive function, functional status, fatigue, mortality and the quality of life 6 and 12 months after ICU admission of the COVID-19 patients enrolled in the Danish ICU COVID-19 database. Furthermore to investigate the association between ventilator days and Clinical Frailty Score (CFS) and the MiniMoCA, respectively at 6 and 12 months after ICU admission

Official Title
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Long-term Cognitive and Functional Status After COVID-19 Treatment at Danish ICUs

Conditions
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Covid19

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 18 years enrolled in the 'Danish ICU COVID-19 database' Exclusion Criteria: non danish speaking patients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The cognitive status at 6 and 12 months after ICU admission using the validated instrument MiniMoCA | The cognitive status at 6 and 12 months after ICU admission using the validated instrument MiniMoCA. Score 0-15, score above 11 indicate normal cognitive function. Two time points to see if there is a change in the cognitive status over time. | at 6 and 12 months after ICU admission | 
| The functional status at 6 and 12 months after ICU admission using the validated instrument CFS | The functional status at 6 and 12 months after ICU admission using the validated instrument CFS (score 1-9) higher levels indicate more frailty. Two time points to see if there is a change in the frailty status over time. | at 6 and 12 months after ICU admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The association between ventilator days and CFS 6 and 12 months after ICU admission | The association between ventilator days and CFS 6 and 12 months after ICU admission. Will be one analysis. | at 6 and 12 months after ICU admission | 
| The association between ventilator days and MiniMoCA 6 and 12 months after ICU admission | The association between ventilator days and MiniMoCA 6 and 12 months after ICU admission. Will be one analysis. But need to time points to see if there is a change. | at 6 and 12 months after ICU admission | 
| Mortality 6 and 12 months after ICU admission | Mortality 6 and 12 months after ICU admission. To see if there is a change i mortality at 6 and 12 months. | at 6 and 12 months after ICU admission | 
| EQ-5D-5L score 6 and 12 months after ICU admission | EQ-5D-5L score 6 and 12 months after ICU admission. Score 5-25. low score indicate better quality of life. Two time points to see if there is a change. | at 6 and 12 months after ICU admission | 
| Barthel ADL score 6 and 12 months after ICU admission | Barthel ADL score 6 and 12 months after ICU admission. Score 0-20, high score indicate high independence. Two time points to see if there is a change. | at 6 and 12 months after ICU admission | 
| Lawton-Brody IADL score 6 and 12 months after ICU admission | Lawton-Brody IADL score 6 and 12 months after ICU admission. score from 0-8 for female and 0-5 for male. High score indicate high independence. Two time points to see if there is a change. | at 6 and 12 months after ICU admission | 
| FAS score 6 and 12 months after ICU admission | FAS score 6 and 12 months after ICU admission. score from 10-50, high score indicate high level of fatigue. Two time points to see if there is a change. | at 6 and 12 months after ICU admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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covid-19, danish icu, long-term follow-up