COVID-19 Follow up Intensive Care Studies

COVID-19 Clinical Trial

— COFICS  

Official title:

COVID-19 Follow up Intensive Care Studies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04460170
• Other study ID #: COFICS201800422
• Status: Recruiting
• Start date: July 1, 2020
• Est. completion date: February 1, 2022

Study information

• Verified date: July 2020
• Source: University Medical Center Groningen
• Contact: I van der Meulen, PhD
• Phone: +31503615617
• Email: i.c.van.der.meulen[@]pl.hanze.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• COVID-19
• Quality of Life

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Center Groningen	Hanze University of Applied Sciences Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

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