COVID-19 Follow up Intensive Care Studies

• Conditions: COVID-19; Quality of Life

• Registration Number: NCT04460170
• Lead Sponsor: University Medical Center Groningen

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-06-29
• Status Verified: 2020-07
• Study Start: 2020-07-01
• Study First Submitted QC: 2020-07-06
• Study First Posted: 2020-07-07
• Last Update Submitted: 2020-07-27
• Last Update Posted: 2020-07-28
• Primary Completion: 2022-02-01
• Study Completion: 2022-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effect of an ICU admission on return to work	12 months post ICU discharge	Return to work knowing; possible job loss, change of work activities and worsening employment status
Anxiety and Depression	12 months post ICU discharge	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.
Frailty	12 months post ICU discharge (only in patients)	Clinical Frailty Scale with a single outcome measure summarizing the overall level of fitness.
General Health	12 months post ICU discharge	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.
Long function	12 months post ICU discharge (only in patients)	Spirometry test
Family functioning	12 months post ICU discharge	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands