Since the SARS-CoV-2 infection is relatively new, the long term attributable burden related to COVID19 has not been investigated yet. To date, in patients with COVID-19 and their family members, there is little information on the functional status, cognitive ability, pattern of return to work, and health related quality of life after the ICU admission. This study aims to describe the psychological wellbeing, physical - and social functioning of COVID-19 ICU survivors and their family members up to 12 months following ICU discharge.
Study design The COVID-19 Follow up Intensive Care Study (COFICS) is a single center, prospective cohort study performed at a University Medical Center in The Netherlands. Study population The study population consists of all admitted critically ill COVID-19 patients with a \> 48 hours ICU admission at the ICU of a University Medical Center and a family member of the patient. Family members in this study can be partners, other family members, or friends who are identified by the patient as important. Sample size All consecutive patients admitted to the ICU of the University Hospital for respiratory distress due to COVID-19 between March 19th 2020 and September 30th 2020 will be enrolled. With consent of the patient, family member(s) of participating patients will be enrolled.
Study Type
OBSERVATIONAL
Enrollment
122
University Medical Center Groningen
Groningen, Netherlands
General Health
MOS Short-Form General Health Survey (SF-20). The SF-20 contains 20 items and has six dimensions; physical functioning (min. score 6, max. score 12) rolefunctioning (min. score 2, max. score 4) social functioning (min. score 1, max. score 6) mental health (min. score 5, max. score 30) general health (min. score 5, max. score 25) pain (min. score 1, max score 5) All endscores will be transformed to a 100 points scale where a higher score means better functioning. Except for pain where a higher score means more pain. The five mental health questions will be excluded from our questionnaire because the questions are comparable with the HADS.
Time frame: 3 months post ICU discharge
General Health
MOS Short-Form General Health Survey (SF-20). The SF-20 contains 20 items and has six dimensions; physical functioning (min. score 6, max. score 12) rolefunctioning (min. score 2, max. score 4) social functioning (min. score 1, max. score 6) mental health (min. score 5, max. score 30) general health (min. score 5, max. score 25) pain (min. score 1, max score 5) All endscores will be transformed to a 100 points scale where a higher score means better functioning. Except for pain where a higher score means more pain. The five mental health questions will be excluded from our questionnaire because the questions are comparable with the HADS.
Time frame: 6 months post ICU discharge
General Health
MOS Short-Form General Health Survey (SF-20). The SF-20 contains 20 items and has six dimensions; physical functioning (min. score 6, max. score 12) rolefunctioning (min. score 2, max. score 4) social functioning (min. score 1, max. score 6) mental health (min. score 5, max. score 30) general health (min. score 5, max. score 25) pain (min. score 1, max score 5) All endscores will be transformed to a 100 points scale where a higher score means better functioning. Except for pain where a higher score means more pain. The five mental health questions will be excluded from our questionnaire because the questions are comparable with the HADS.
Time frame: 12 months post ICU discharge
Anxiety and Depression
Hospital Anxiety and Depression Scale (HADS). The HADS contains two subscale of 7 items each. Minimal score is 0, maximal score 21 for each subscale where a higher score means a higher burden.
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Time frame: 3 months post ICU discharge
Anxiety and Depression
Hospital Anxiety and Depression Scale (HADS). The HADS contains two subscale of 7 items each. Minimal score is 0, maximal score 21 for each subscale where a higher score means a higher burden.
Time frame: 6 months post ICU discharge
Anxiety and Depression
Hospital Anxiety and Depression Scale (HADS). The HADS contains two subscale of 7 items each. Minimal score is 0, maximal score 21 for each subscale where a higher score means a higher burden.
Time frame: 12 months post ICU discharge
Long function
Spirometry test
Time frame: 6 months post ICU discharge (only in patients)
Long function
Spirometry test
Time frame: 12 months post ICU discharge (only in patients)
Frailty
Clinical Frailty Scale with a single outcome measure summarizing the overall level of fitness.
Time frame: 3 months post ICU discharge (only in patients)
Frailty
Clinical Frailty Scale with a single outcome measure summarizing the overall level of fitness.
Time frame: 6 months post ICU discharge (only in patients)
Frailty
Clinical Frailty Scale with a single outcome measure summarizing the overall level of fitness.
Time frame: 12 months post ICU discharge (only in patients)
Family functioning
McMaster Family Assessment Device (FAD-GF6+). The FAD-GF6+ contains 6 items (min. score 6, max. score 24) where a higher scores indicate a lower caregiver burden.
Time frame: 6 months post ICU discharge
Family functioning
McMaster Family Assessment Device (FAD-GF6+). The FAD-GF6+ contains 6 items (min. score 6, max. score 24) where a higher scores indicate a lower caregiver burden.
Time frame: 12 months post ICU discharge
Effect of an ICU admission on return to work
Return to work knowing; possible job loss, change of work activities and worsening employment status
Time frame: 3 months post ICU discharge (only in family members)
Effect of an ICU admission on return to work
Return to work knowing; possible job loss, change of work activities and worsening employment status
Time frame: 6 months post ICU discharge
Effect of an ICU admission on return to work
Return to work knowing; possible job loss, change of work activities and worsening employment status
Time frame: 12 months post ICU discharge
age
age (years)
Time frame: 24 hours (patient) / 3 months post ICU discharge (family member)
Gender
Gender (male/female)
Time frame: 24 hours (patient) / 3 months post ICU discharge (family member)
Social status
Social status (married/living together/ single)
Time frame: 3 months post ICU discharge
APACHE IV
Acute Physiology And Chronic Health Evaluation (APACHE IV). It is applied within 24 hours of admission of a patient to an intensive care unit (ICU): based on several measurements; higher scores correspond to more severe disease and a higher risk of death
Time frame: 24 hours (only in patients)
Comorbidity
Comorbidity ( free text)
Time frame: 3 months post ICU discharge (only in patients)
Body mass index
Body mass index (kg/m2)
Time frame: 3 months post ICU discharge (only in patients)
ICU stay
ICU stay (days)
Time frame: hospital discharge, an average of 4 weeks (only in patients)
Mechanical ventilation
Mechanical ventilation (days)
Time frame: hospital discharge, an average of 4 weeks (only in patients)
Delerium
Delerium (no / yes --\> CAM-ICU / DOS score)
Time frame: hospital discharge, an average of 4 weeks (only in patients)
Hospital stay
Hospital stay (days)
Time frame: hospital discharge, an average of 4 weeks (only in patients)
Discharge locationn
Discharge location (home, other hospital, nursing home, revelidation center)
Time frame: hospital discharge, an average of 4 weeks (only in patients)
Mortality
Mortality (no / yes --\> date)
Time frame: 3 months post ICU discharge (only in patients)
Mortality
Mortality (no / yes --\> date)
Time frame: 6 months post ICU discharge (only in patients)
Mortality
Mortality (no / yes --\> date)
Time frame: 12 months post ICU discharge (only in patients)
Relationship with the patient
Relationship with the patient (Partner, sibling, child, other)
Time frame: 3 months post ICU discharge (only in family members)
Educational level
Educational level (low, middle, high)
Time frame: 3 months post ICU discharge
Readmission
Readmission (no / yes --\> free text)
Time frame: 3 months post ICU discharge (only in patients)
Health care consumption
Health care consumption (general practicionar, home care, physiotherapist, lung specialist, psychologist, onther (free text))
Time frame: 3 months post ICU discharge
Health care consumption
Health care consumption (general practicionar, home care, physiotherapist, lung specialist, psychologist, onther (free text))
Time frame: 6 months post ICU discharge
Health care consumption
Health care consumption (general practicionar, home care, physiotherapist, lung specialist, psychologist, onther (free text))
Time frame: 12 months post ICU discharge
Weight
Weight (kg)
Time frame: 3 months post ICU discharge
Weight
Weight (kg)
Time frame: 6 months post ICU discharge
Weight
Weight (kg)
Time frame: 12 months post ICU discharge
Hypertensive
Hypertensive (RR)
Time frame: 3 months post ICU discharge
Hypertensive
Hypertensive (RR)
Time frame: 6 months post ICU discharge
Hypertensive
Hypertensive (RR)
Time frame: 12 months post ICU discharge
Thrombosis
Thrombosis (no / yes --\> anticoagulant, DVT or PE)
Time frame: 3 months post ICU discharge
Thrombosis
Thrombosis (no / yes --\> anticoagulant, DVT or PE)
Time frame: 6 months post ICU discharge
Thrombosis
Thrombosis (no / yes --\> anticoagulant, DVT or PE)
Time frame: 12 months post ICU discharge
Diabetes
Diabetes (no /yes --\> current insulin level, metformin/ insulin use)
Time frame: 3 months post ICU discharge
Diabetes
Diabetes (no /yes --\> current insulin level, metformin/ insulin use)
Time frame: 6 months post ICU discharge
Diabetes
Diabetes (no /yes --\> current insulin level, metformin/ insulin use)
Time frame: 12 months post ICU discharge