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The COGCOV Study in ICU Patients (COGCOV)

Primary Purpose

Covid19, Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Neurocognitive assessment
Sponsored by
Ziekenhuis Oost-Limburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Admitted to the intensive care unit of Ziekenhuis Oost-Limburg
  • Being hospitalized between March 2020 and May 2020, and therefore being admitted 6 months prior to the study
  • The reason of hospitalization was COVID-19 disease

Exclusion Criteria:

  • No willingness to participate, and therefore not having signed the informed consent

Sites / Locations

  • Ziekenhuis Oost-Limburg

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

COVID-19 patients

Arm Description

Neurocognitive impairment in COVID-19 patients

Outcomes

Primary Outcome Measures

Neurocognitive impairment measured by RBANS
the Repeatable Battery for the Assessment of Neuropsychological Statusis (RBANS) is a neuropsychological test that provides information about 5 domains of cognition (1) immediate and (2) delayed memory, (3) attention, (4) visuospatial construction and (5) language) and provides a total score. It is a test that takes about 30 minutes and consists of twelve tests. These are: (1) List Learning, (2) Story Memory, (3) Figure Copy, (4) Line Orientation, (5) Picture Naming, (6) Semantic Fluency, (7) Digit Span, (8) Coding, (9) List Recall, (10) List Recognition, (11) Story Recall and (12) Figure Recall. According to the RBANS manual, the possible values for the RBANS scores at the item, domain, and scale level are 0 to 89, 40 to 154, and 40 to 160

Secondary Outcome Measures

Neurocognitive impairment measured by TMT
Trail Making Test (TMT) is a test of executive functioning, visual search speed, scanning, speed of processing and mental flexibility. The total score is the time in seconds spent to complete each part.
Neurocognitive impairment by the short IQCODE
The short IQCODE is a 16 question long questionnaire that assesses cognitive impairment in elderly patients. An informant is required to rate a patient's cognitive changes over a 10 year time period. Each question is scored from 1 (much improved over time) to 5 (much worse).

Full Information

First Posted
October 12, 2020
Last Updated
April 12, 2023
Sponsor
Ziekenhuis Oost-Limburg
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1. Study Identification

Unique Protocol Identification Number
NCT04593069
Brief Title
The COGCOV Study in ICU Patients
Acronym
COGCOV
Official Title
Long-term Cognitive Impairment in ICU Patients, Admitted for COVID-19 Pneumonia: a Single Centre, Prospective Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
October 7, 2020 (Actual)
Primary Completion Date
January 13, 2021 (Actual)
Study Completion Date
January 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ziekenhuis Oost-Limburg

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Acute Respiratory Distress syndrome (ARDS) is a pulmonary systematic inflammatory response, leading to acute respiratory failure with hypoxia and/or hypercarbia. COVID-19 evokes a viral pneumonia, which may result in ARDS as well. It is not yet clear if COVID-19 disease behaves like the typical ARDS. Corona virus causes primarily deep hypoxia. Hypoxia, on its own, can lead to long term cognitive impairment. However, critical illness also affects long-term neurocognitive functioning. The investigators will be researching the possibility of long-term cognitive impairment in COVID-19 ICU patients, in comparison with reference values of a healthy population as well as the values measured in critically ill patients, admitted not only for respiratory reasons.
Detailed Description
The investigators will conduct a single centre, prospective cohort study. COVID-19 patients from the Ziekenhuis Oost-Limburg cohort will be contacted by phone 6 months after admission at the ICU. Patients will be asked to participate in a study surrounding long term symptoms of COVID-19. When consent is given by the patiënt, the experimenter will conduct a short questionnaire over the phone with the patient or relative that is present at the time of the call. If the participant is fluent in Dutch, the experimenter will ask permission to visit their home to conduct more testing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Cognitive Impairment

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All patients enrolled in the study will be contacted to answer additional questions regarding cognitive impairment
Masking
None (Open Label)
Masking Description
masking is not applicable for this study
Allocation
N/A
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
COVID-19 patients
Arm Type
Other
Arm Description
Neurocognitive impairment in COVID-19 patients
Intervention Type
Behavioral
Intervention Name(s)
Neurocognitive assessment
Intervention Description
6 months after admission to the intensive care unit of Ziekenhuis Oost-Limburg, the patients will be tested on cognitive impairment
Primary Outcome Measure Information:
Title
Neurocognitive impairment measured by RBANS
Description
the Repeatable Battery for the Assessment of Neuropsychological Statusis (RBANS) is a neuropsychological test that provides information about 5 domains of cognition (1) immediate and (2) delayed memory, (3) attention, (4) visuospatial construction and (5) language) and provides a total score. It is a test that takes about 30 minutes and consists of twelve tests. These are: (1) List Learning, (2) Story Memory, (3) Figure Copy, (4) Line Orientation, (5) Picture Naming, (6) Semantic Fluency, (7) Digit Span, (8) Coding, (9) List Recall, (10) List Recognition, (11) Story Recall and (12) Figure Recall. According to the RBANS manual, the possible values for the RBANS scores at the item, domain, and scale level are 0 to 89, 40 to 154, and 40 to 160
Time Frame
6 months after admission at the intensive care unit
Secondary Outcome Measure Information:
Title
Neurocognitive impairment measured by TMT
Description
Trail Making Test (TMT) is a test of executive functioning, visual search speed, scanning, speed of processing and mental flexibility. The total score is the time in seconds spent to complete each part.
Time Frame
6 months after admission at the intensive care unit
Title
Neurocognitive impairment by the short IQCODE
Description
The short IQCODE is a 16 question long questionnaire that assesses cognitive impairment in elderly patients. An informant is required to rate a patient's cognitive changes over a 10 year time period. Each question is scored from 1 (much improved over time) to 5 (much worse).
Time Frame
6 months after admission at the intensive care unit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Admitted to the intensive care unit of Ziekenhuis Oost-Limburg Being hospitalized between March 2020 and May 2020, and therefore being admitted 6 months prior to the study The reason of hospitalization was COVID-19 disease Exclusion Criteria: No willingness to participate, and therefore not having signed the informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dieter Mesotten, MD
Organizational Affiliation
Ziekenhuis Oost-Limburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
ZIP/Postal Code
3600
Country
Belgium

12. IPD Sharing Statement

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The COGCOV Study in ICU Patients

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