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

NCT04910334 | Unknown

• 1 other identifier: REG-135-2020
• Study Type: observational
• Target: 203
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

covid-19; danish icu; long-term follow-up

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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 MiniMoCA 6 and 12 months after ICU admission

  at 6 and 12 months after ICU admission

• Mortality 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

  at 6 and 12 months after ICU admission

• Barthel ADL score 6 and 12 months after ICU admission

  at 6 and 12 months after ICU admission

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is all Danish speaking COVID-19 patients, admitted and treated at one of the 29 Danish ICUs, and enrolled in the 'Danish ICU COVID-19 database' from March 10th and forward. Patients are 18 of age and above with a positive polymerase chain reaction (PCR) test for SARS-CoV-2 either prior to or during ICU admission

You may qualify if:

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

You may not qualify if:

• non danish speaking patients

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Department of Anaesthesiology

Køge, 4600, Denmark

Location

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

• Lone Poulsen, MD

  Department of Anaesthesiology and Intensive Care

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: June 2, 2021
• Study Start: October 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: September 1, 2021
• Last Updated: June 2, 2021

Record last verified: 2021-06

Locations

DK (1)