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

• Conditions: Covid19

• Registration Number: NCT04910334
• Lead Sponsor: Zealand University Hospital

Brief Summary

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

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

Study Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2021-02-04
• Status Verified: 2021-06
• Primary Completion: 2021-06-01
• Study First Submitted QC: 2021-06-01
• Last Update Submitted: 2021-06-01
• Study First Posted: 2021-06-02
• Last Update Posted: 2021-06-02
• Study Completion: 2021-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 203

Inclusion Criteria

• > 18 years
• enrolled in the 'Danish ICU COVID-19 database'

Exclusion Criteria

• non danish speaking patients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The cognitive status at 6 and 12 months after ICU admission using the validated instrument MiniMoCA	at 6 and 12 months after ICU admission	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.
The functional status at 6 and 12 months after ICU admission using the validated instrument CFS	at 6 and 12 months after ICU admission	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.

Secondary Outcome Measures

Name	Time	Method
The association between ventilator days and CFS 6 and 12 months after ICU admission	at 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.
The association between ventilator days and MiniMoCA 6 and 12 months after ICU admission	at 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.
Mortality 6 and 12 months after ICU admission	at 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.
EQ-5D-5L score 6 and 12 months after ICU admission	at 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.
Barthel ADL score 6 and 12 months after ICU admission	at 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.
Lawton-Brody IADL score 6 and 12 months after ICU admission	at 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.
FAS score 6 and 12 months after ICU admission	at 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.

Trial Locations

Locations (1)

Department of Anaesthesiology; 🇩🇰 Køge, Denmark