To investigate the neurological and neuropsychological sequelae of COVID-19 infection for which ICU or non-ICU hospital admission was necessary in the spring of 2020 and for which ICU admission was necessary in the fall of 2020, and its consequences…
ID
Source
Brief title
Condition
- Neurological disorders NEC
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Patient-related outcome: participation and quality of life. Caregiver-related
outcome: caregiver burden and quality of life. Neurological outcome: MRI
abnormalities and neurological symptoms. Neuropsychological outcome: global and
domain-specific deficits in cognitive functioning. Emotional outcome: mood and
impact of event. Secondary outcomes: subjective complaints in several areas of
functioning.
Secondary outcome
not applicable
Background summary
Severe COVID-19 infection may lead to brain damage, but information is
currently lacking because this is a new disease.
Study objective
To investigate the neurological and neuropsychological sequelae of COVID-19
infection for which ICU or non-ICU hospital admission was necessary in the
spring of 2020 and for which ICU admission was necessary in the fall of 2020,
and its consequences on daily life functioning and quality of life on patients
and primary caregivers.
Study design
Multicentre follow-up cohort study with measurements at minimally 6 and 6
months later post discharge from hospital.
Study burden and risks
We foresee no additional risk of measurements. Additional burden consists of
one MRI scan and cognitive tests: max 3 hours during the visit at 6-9 months,
and twice 30-40 minutes of filling in questionnaires (patients and caregivers)
at home at minimalyy 6 months and 6 months later. No potential benefits from
participating in this study.
Universiteitsingel 40
Maastricht 6229 ER
NL
Universiteitsingel 40
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
Patients:
- Objectified COVID-19 infection for which ICU or hospital admission was
necessary at one of the participating hospitals
- Age > 18 years
- Sufficient command of the Dutch language to follow test instructions and
understand questionnaires
- Informed consent.
Primary caregivers (if present):
- Primary caregiver (spouse or close family member who takes care of the
patient most) of a participant with COVID-19 infection as described above
- Age > 18 years
- Sufficient command of the Dutch language to understand questionnaires
- Informed consent.
Patients subgroup second/third wave :
- Objectified COVID-19 infection for which ICU or non-ICU hospital admission
was necessary at the MUMC+one of the participating hospitals
- Age > 18 years
- Sufficient command of the Dutch language to follow test instructions and
understand questionnaires
- Informed consent
- Treated with both dexamethasone and tocilizumab during ICU admission.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
Patients:
- objectified cognitive impairments before the hospital admission for the
COVID-19 infection
- an unexpected incident leading to severe neurological damage occurring after
hospital discharge (such as stroke or traumatic brain injury)
- contra-indications for MRI scanning (e.g. metal implants, cardiac pacemaker,
claustrophobia, pregnancy)
-- physical inability to independently travel to one of the participating
hospitals (e.g., bedridden patients).
Primary caregivers: no exclusion criteria.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL75102.068.20 |