Clinical trial NCT04460170: COVID-19 Follow up Intensive Care Studies
Official title: COVID-19 Follow up Intensive Care Studies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Quality of Life
COVID-19
Keywords: Critical Care
Family Members
Patients
Follow-Up Studies
Quality of Life
COVID-19
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Hanze University of Applied Sciences Groningen
First posted: 2020-07-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: General Health
timeFrame: 3 months post ICU discharge
measure: General Health
timeFrame: 6 months post ICU discharge
measure: General Health
timeFrame: 12 months post ICU discharge
measure: Anxiety and Depression
timeFrame: 3 months post ICU discharge
measure: Anxiety and Depression
timeFrame: 6 months post ICU discharge
measure: Anxiety and Depression
timeFrame: 12 months post ICU discharge
measure: Long function
timeFrame: 6 months post ICU discharge (only in patients)
measure: Long function
timeFrame: 12 months post ICU discharge (only in patients)
measure: Frailty
timeFrame: 3 months post ICU discharge (only in patients)
measure: Frailty
timeFrame: 6 months post ICU discharge (only in patients)
measure: Frailty
timeFrame: 12 months post ICU discharge (only in patients)
measure: Family functioning
timeFrame: 6 months post ICU discharge
measure: Family functioning
timeFrame: 12 months post ICU discharge
measure: Effect of an ICU admission on return to work
timeFrame: 3 months post ICU discharge (only in family members)
measure: Effect of an ICU admission on return to work
timeFrame: 6 months post ICU discharge
measure: Effect of an ICU admission on return to work
timeFrame: 12 months post ICU discharge
Secondary outcomes:
measure: age
timeFrame: 24 hours (patient) / 3 months post ICU discharge (family member)
measure: Gender
timeFrame: 24 hours (patient) / 3 months post ICU discharge (family member)
measure: Social status
timeFrame: 3 months post ICU discharge
measure: APACHE IV
timeFrame: 24 hours (only in patients)
measure: Comorbidity
timeFrame: 3 months post ICU discharge (only in patients)
measure: Body mass index
timeFrame: 3 months post ICU discharge (only in patients)
measure: ICU stay
timeFrame: hospital discharge, an average of 4 weeks (only in patients)
measure: Mechanical ventilation
timeFrame: hospital discharge, an average of 4 weeks (only in patients)
measure: Delerium
timeFrame: hospital discharge, an average of 4 weeks (only in patients)
measure: Hospital stay
timeFrame: hospital discharge, an average of 4 weeks (only in patients)
measure: Discharge locationn
timeFrame: hospital discharge, an average of 4 weeks (only in patients)
measure: Mortality
timeFrame: 3 months post ICU discharge (only in patients)
measure: Mortality
timeFrame: 6 months post ICU discharge (only in patients)
measure: Mortality
timeFrame: 12 months post ICU discharge (only in patients)
measure: Relationship with the patient
timeFrame: 3 months post ICU discharge (only in family members)
measure: Educational level
timeFrame: 3 months post ICU discharge
measure: Readmission
timeFrame: 3 months post ICU discharge (only in patients)
measure: Health care consumption
timeFrame: 3 months post ICU discharge
measure: Health care consumption
timeFrame: 6 months post ICU discharge
measure: Health care consumption
timeFrame: 12 months post ICU discharge
measure: Weight
timeFrame: 3 months post ICU discharge
measure: Weight
timeFrame: 6 months post ICU discharge
measure: Weight
timeFrame: 12 months post ICU discharge
measure: Hypertensive
timeFrame: 3 months post ICU discharge
measure: Hypertensive
timeFrame: 6 months post ICU discharge
measure: Hypertensive
timeFrame: 12 months post ICU discharge
measure: Thrombosis
timeFrame: 3 months post ICU discharge
measure: Thrombosis
timeFrame: 6 months post ICU discharge
measure: Thrombosis
timeFrame: 12 months post ICU discharge
measure: Diabetes
timeFrame: 3 months post ICU discharge
measure: Diabetes
timeFrame: 6 months post ICU discharge
measure: Diabetes
timeFrame: 12 months post ICU discharge
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
References: