Uppföljning Av Psykiatriska, Kognitiva Och Neurologiska Symtom Hos Post COVID-19 Patienter.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- Region Örebro County
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- Change in cognitive functions measured with Mindmore and change in cognitive profile in Mindmore.
- Status
- Active, Not Recruiting
- Last Updated
- last year
Overview
Brief Summary
The prospective, longitudinal, open observational study monitors patients with cognitive and neuropsychological symptoms after COVID-19 infection, in a longitudinal manner to see how the disease has affected their physical, psychological and cognitive function, their ability to be active, return to work, their health-related quality of life in correlation with potential diagnostic and prognostic markers.
Detailed Description
The aim is to increase knowledge of the underlying biological processes; how biomarkers correlate with degree of symptoms, mapping their role as diagnostic markers over time (24 months). The investigators follow up to 100 study participants with post-acute sequelae of SARS-CoV-2 infection (PASC) for 24 months, measure their physical, psychological and neurocognitive symtoms and how they change over time (three visits: baseline, 12 months, 24 months) in correlation with biomarkers in blood, cerebrospinal fluid and faeces samples as well as neuroradiological changes on MRI (baseline, 24 months). Knowledge about the late effects of COVID-19 and its pathogenesis is still unknown. The findings of the study can therefore be used as a guidance for future actions in healthcare and, in the best case, can lead to a possible, either curative or symptom-relieving, treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •neurocognitive symptoms after lab-verified COVID-19 infection
Exclusion Criteria
- •severe illness e.g cancer with a short expected survival time
- •ongoing alcohol abuse
- •ongoing drug abuse.
Outcomes
Primary Outcomes
Change in cognitive functions measured with Mindmore and change in cognitive profile in Mindmore.
Time Frame: baseline, 12 months, 24 months
Two digital neurocognitive test batteries (Mindmore): dementia and fatigue/depression
Symptom improvement in depression
Time Frame: baseline, 12 months, 24 months
Montgomery Asberg Depression Rating Scale (MADRS) has has 10 items that are completed during a clinical interview.. The items of the MADRS are as follows: apparent sadness, reported sadness inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thought, suicidal thoughts. MADRS assess the severity of depression. The severity of symptoms is rated by the physician. Each item has a severity scale from 0 to 6, with higher scores reflecting more severe symptoms. Ratings can be added to form an overall score (from 0 to 60) and the higher score means a worse outcome.
Self-reported symptom improvement in depression
Time Frame: baseline, 12 months, 24 months
Montgomery Asberg Depression Rating Scale, Self-report version (MADRS-S) has 9-items which are based on feelings over the past 3 days. The items of the MADRS-S are as follows: Mood; Feelings of unease; Sleep; Appetite; Ability to concentrate; Initiative; Emotional involvement; Pessimism; Zest for life. MADRS-S assess the severity of depression. The severity of symptoms is rated by the study participant. Each item has a severity scale from 0 to 6, with higher scores reflecting more severe symptoms. Ratings can be added to form an overall score (from 0 to 54) and the higher score means a worse outcome.
Rate of self-reported symptoms suggestive of post-traumatic stress disorder (PTSD)
Time Frame: baseline, 12 months, 24 months
The Post-traumatic Stress Disorder Checklist for The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, DSM-5 (PCL-5) is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The study partipicipant answer first a brief Criterion A för PTSD. If the answer is affirmative (i.e. PTSD is suspected) the participants continue with 20 questions (items). Each item is rated from 0 ("not at all") to 4 ("extremely") to indicate the degree to which they have been bothered by that particular symptom over the past month. Ratings can be added to form an overall score (from 0 to 80) and the higher score means a worse outcome.
Grade of self-reported mental fatigue
Time Frame: baseline, 12 months, 24 months
The Mental Fatigue scale (MFS) includes 14 questions that measure mental fatigue. Questions include affective, cognitive and sensory symptoms, duration of sleep and daytime variation in symptom severity. The questions concern fatigue in general, lack of initiative, mental fatigue, mental recovery, concentration difficulties, memory problems, slowness of thinking, sensitivity to stress, increased tendency to become emotional, irritability, sensitivity to light and noise, decreased or increased sleep. One additional question includes 24-hour symptom variations. The severity of symptoms is rated by the study participant. A rating of 0 corresponds to normal function and 1-3 indicating increasing problem with the symptom (No (0), Slight (1), Fairly serious (2) and Serious (3) problems). Ratings can be added to form an overall score (from 0 to 42) and the higher score means a worse outcome.
Grade of self-reported stress
Time Frame: baseline, 12 months, 24 months
Th Perceived Stress Scale (PSS-14) is a self-reported measure which assesses the degree to which the respondent has perceived situations in his/her life within the past month as stressful. The PSS-14 is comprised of 14 items intended to measure how unpredictable, uncontrollable, and overloaded individuals find their life circumstances. Individuals rate items on a 5-point Likert scale, ranging from 0 - "Never" to 4 - "Very often." Scores range from 0-56, with higher scores indicating greater perceived stress.
Grade of self-reported cognitive failures in everyday life
Time Frame: baseline, 12 months, 24 months
The cognitive Failures Questionnaire (CFQ) is a self-report questionnaire consisting of 25 items assessing deficits regarding attention, perception, memory and motor functioning in everyday life. The total CFQ score is calculated by summation of all answers and scores range from 0-100. A higher total score indicates more subjective cognitive failure.
Secondary Outcomes
- Waist size(baseline, 12 months, 24 months)
- Occurence of APOE4 allele as biomarker of genetic predisposition to Alzheimer's disease and susceptibility to more severe course of COVID-19 infection(baseline)
- Rate of peak expiratory flow (PEF)(baseline, 12 months, 24 months)
- Concentration of neurofilament light (NFL) in cerebrospinal fluid (CSF) as a CSF biomarker of neurodegeneration(baseline, 24 months)
- Concentration of neurofilament light (NFL) in plasma as a blood biomarker of neurodegeneration(baseline, 24 months)
- Concentration of phosphorylated Tau (P-Tau) in cerebrospinal fluid (CSF) as a CSF biomarker of neurodegeneration/taupathy(baseline, 24 months)
- Brain volumes and signal abnormalities in white and gray matter(baseline, 24 months)
- Changes in gut microbiome(Baseline, 24 months)
- Occurence of activity limitations and changes in health-related quality of life (QoL)(baseline, 12 months, 24 months)
- Grade of work incapacity/sick leave and time to return to work(baseline, 12 months, 24 months)
- Grade of physical exercise capacity(baseline, 12 months, 24 months)
- Concetration of Beta-Amyloid 42 in cerebrospinal fluid (CSF) as a CSF biomarker of neurodegeneration.(baseline, 24 months)
- Beta Amyloid Ratio 42/40 in cerebrospinal fluid (CSF) as a CSF biomarker of neurodegeneration linked to Alzheimer's disease(baseline, 24 months)
- Changes in functional and structural brain connectivity(baseline, 24 months)
- Changes in body size(baseline, 12 months, 24 months)
- Concentration of neurogranin in cerebrospinal fluid (CSF) as a CSF biomarker of neurodegeneration linked to Alzheimer's disease(baseline, 24 months)
- Concentration of Tau (P-Tau) protein in cerebrospinal fluid (CSF) as a CSF biomarker of cortikal damage/neurodegeneration(baseline, 24 months)