Primary Objectives: 1. To investigate the nature and extent of persistent fatigue and cognitive complaints 2. To investigate the impact of persistent complaints on health-related quality of life and health care consumption3. To identify risk factors…
ID
Source
Brief title
Condition
- Other condition
- Viral infectious disorders
- Psychiatric disorders NEC
Synonym
Health condition
long COVID-19 (>3 maanden na acute infectie)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Persistent fatigue and cognitive complaints
Secondary outcome
2. Impact of persistent complaints on health-related quality of life, health
care consumption
3. Risk factors for persistent fatigue and cognitive problems: cognitive
behavioural factors (coping, illness perceptions) , cognitive
neuropsychological functioning sociodemographic factors (eg. age, gender),
medical factors (severity of initial covid19 infection, ICU admission,
vaccination status, comorbidity, covid19 virus variant)
4. Post-exertional malaise
Background summary
The magnitude of the current COVID-19 pandemic is unprecedented with >500,000
infections so far in the Netherlands and >54 million
worldwide. A large number of post-COVID-19 patients have already developed
"chronic" complaints, such as fatigue and cognitive complaints, which persist >
3 months after infection (36-53%). Post-infectious fatigue and cognitive
complaints are characterized by chronic, debilitating and unexplained fatigue
and difficulty concentrating and remembering months after an infection. The
exact severity of persistent fatigue and cognitive complaints, maintaining
factors of these complaints and their risk factors are unknown. This study
hopes to shed more light on this.
Study objective
Primary Objectives:
1. To investigate the nature and extent of persistent fatigue and cognitive
complaints
2. To investigate the impact of persistent complaints on health-related quality
of life and health care consumption
3. To identify risk factors for persistent fatigue and cognitive problems:
cognitive behavioural factors (coping, illness perceptions) , cognitive
neuropsychological functioning, sociodemographic factors (eg. age, gender),
medical factors (severity of initial covid19 infection, ICU admission,
vaccination status, comorbidity, covid19 virus variant)
4. To investigate the presence of post-exertional malaise (PEM)
Study design
Cross-sectionele observationele case-control studie
Study burden and risks
A maximum of two study visits will be required, depending on the moment of
inclusion (compared to time of infection). Participants will be asked to
complete an online battery of standardized validated questionnaires at
inclusion (baseline), after 9 months to assess fatigue, cognitive symptoms,
health related quality of life, coping, illness perceptions and health care
consumption. Completion of the battery of questionnaires will take
approximately take a maximum of 45 minutes. Neuropsychological assessment
(approximately 50 minutes) will be performed at baseline. During the first
study visit blood sampling for biomarkers and genotyping is done, of which the
risk is considered minimal. There is no direct benefit of participation in the
study for the patient.
Meibergdreef 9 9
Amsterdam 1105AZ
NL
Meibergdreef 9 9
Amsterdam 1105AZ
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:
- At least 3 months after diagnosis of COVID-19 (hospitalized or
non-hospitalized) confirmed by a positive PCR for SARS-CoV-2, positive
SARS-CoV-2 serology or CO-RADS (COVID-19 Reporting and Data System) >=4 on
CT-scan, or antigen quicktest.
For post COVID-19 participants with long-term fatigue and cognitive complaints
- Experience severe fatigue after going through COVID-19 (>40 on the fatigue
scale of the Checklist Individual Strength (CIS)(Worm-Smeitink et al., 2017))
- A score of >=18 on the concentration subscale of the CIS, at least 3 months
after COVID-19
For post-COVID-19 participants without persisting fatigue and/or cognitive
complaints
- No severe fatigue on the Checklist Individual Strength (CIS)(Worm-Smeitink et
al., 2017)) (score <=34 on the fatigue scale)
- No substantial cognitive complaints <=18 on the concentration subscale of
the CIS) at least 3 months after COVID-19.
Exclusion criteria
Subject who meets any of the following criteria will be excluded from
participation in this study:
- Known psychiatric or somatic conditions prior to COVID-19 that could explain
the fatigue or cognitive symptoms.
- Disabling fatigue and/or cognitive complaints prior to COVID-19.
- Re-infection with SARS-CoV-2 within the last 3 months
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 | NL79575.018.21 |