COVID-19 Follow up Intensive Care Studies (COFICS)

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 Overview

• Status: Unknown
• Conditions: COVID-19; Quality of Life

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: I van der Meulen, PhD; Phone Number: +31503615617; Email: i.c.van.der.meulen@pl.hanze.nl

Study Locations

• Netherlands
  • Groningen, Netherlands, 9700 RB
    • Recruiting
    • University Medical Center Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Collaborators: Hanze University of Applied Sciences Groningen

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): February 1, 2022
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: June 29, 2020
• First Submitted That Met QC Criteria: July 6, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Quality of Life; COVID-19; Patients; Critical Care; Follow-Up Studies; Family Members
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: COFICS201800422

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No