COVID-19 Follow up Intensive Care Studies

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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COVID-19 Follow up Intensive Care Studies

Conditions
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Quality of Life, COVID-19

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years old Ability to speak and write Dutch Ability to conduct a telephone call Diagnosed with COVID-19 infection (only in patients) 48 hours ICU admission (only in patients) Exclusion Criteria: Refuse to participate Serious language barrier Cognitive impairment Severe psychiatric disorder Chronic ventilator dependency (only in patients)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 12 months post ICU discharge | 
| Long function | Spirometry test | 6 months post ICU discharge (only in patients) | 
| Long function | Spirometry test | 12 months post ICU discharge (only in patients) | 
| Frailty | Clinical Frailty Scale with a single outcome measure summarizing the overall level of fitness. | 3 months post ICU discharge (only in patients) | 
| Frailty | Clinical Frailty Scale with a single outcome measure summarizing the overall level of fitness. | 6 months post ICU discharge (only in patients) | 
| Frailty | Clinical Frailty Scale with a single outcome measure summarizing the overall level of fitness. | 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. | 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. | 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 | 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 | 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 | 12 months post ICU discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| age | age (years) | 24 hours (patient) / 3 months post ICU discharge (family member) | 
| Gender | Gender (male/female) | 24 hours (patient) / 3 months post ICU discharge (family member) | 
| Social status | Social status (married/living together/ single) | 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 | 24 hours (only in patients) | 
| Comorbidity | Comorbidity ( free text) | 3 months post ICU discharge (only in patients) | 
| Body mass index | Body mass index (kg/m2) | 3 months post ICU discharge (only in patients) | 
| ICU stay | ICU stay (days) | hospital discharge, an average of 4 weeks (only in patients) | 
| Mechanical ventilation | Mechanical ventilation (days) | hospital discharge, an average of 4 weeks (only in patients) | 
| Delerium | Delerium (no / yes --> CAM-ICU / DOS score) | hospital discharge, an average of 4 weeks (only in patients) | 
| Hospital stay | Hospital stay (days) | hospital discharge, an average of 4 weeks (only in patients) | 
| Discharge locationn | Discharge location (home, other hospital, nursing home, revelidation center) | hospital discharge, an average of 4 weeks (only in patients) | 
| Mortality | Mortality (no / yes --> date) | 3 months post ICU discharge (only in patients) | 
| Mortality | Mortality (no / yes --> date) | 6 months post ICU discharge (only in patients) | 
| Mortality | Mortality (no / yes --> date) | 12 months post ICU discharge (only in patients) | 
| Relationship with the patient | Relationship with the patient (Partner, sibling, child, other) | 3 months post ICU discharge (only in family members) | 
| Educational level | Educational level (low, middle, high) | 3 months post ICU discharge | 
| Readmission | Readmission (no / yes --> free text) | 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)) | 3 months post ICU discharge | 
| Health care consumption | Health care consumption (general practicionar, home care, physiotherapist, lung specialist, psychologist, onther (free text)) | 6 months post ICU discharge | 
| Health care consumption | Health care consumption (general practicionar, home care, physiotherapist, lung specialist, psychologist, onther (free text)) | 12 months post ICU discharge | 
| Weight | Weight (kg) | 3 months post ICU discharge | 
| Weight | Weight (kg) | 6 months post ICU discharge | 
| Weight | Weight (kg) | 12 months post ICU discharge | 
| Hypertensive | Hypertensive (RR) | 3 months post ICU discharge | 
| Hypertensive | Hypertensive (RR) | 6 months post ICU discharge | 
| Hypertensive | Hypertensive (RR) | 12 months post ICU discharge | 
| Thrombosis | Thrombosis (no / yes --> anticoagulant, DVT or PE) | 3 months post ICU discharge | 
| Thrombosis | Thrombosis (no / yes --> anticoagulant, DVT or PE) | 6 months post ICU discharge | 
| Thrombosis | Thrombosis (no / yes --> anticoagulant, DVT or PE) | 12 months post ICU discharge | 
| Diabetes | Diabetes (no /yes --> current insulin level, metformin/ insulin use) | 3 months post ICU discharge | 
| Diabetes | Diabetes (no /yes --> current insulin level, metformin/ insulin use) | 6 months post ICU discharge | 
| Diabetes | Diabetes (no /yes --> current insulin level, metformin/ insulin use) | 12 months post ICU discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Critical Care, Family Members, Patients, Follow-Up Studies, Quality of Life, COVID-19