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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04910334
• Other study ID #: REG-135-2020
• Status: Enrolling by invitation
• Start date: October 1, 2020
• Est. completion date: September 1, 2021

Study information

• Verified date: June 2021
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 203
• Est. completion date: September 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• > 18 years

• enrolled in the 'Danish ICU COVID-19 database'

Exclusion Criteria:

• non danish speaking patients

Related Conditions & MeSH terms

• Covid19

Locations

Country	Name	City	State
Denmark	Department of Anaesthesiology	Køge

Sponsors (1)

Lead Sponsor	Collaborator
Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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