COVID-19 Follow up Intensive Care Studies

NCT ID: NCT04460170

Last Updated: 2020-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2022-02-01

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.

Conditions

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Quality of Life COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hanze University of Applied Sciences Groningen

OTHER

Sponsor Role collaborator

University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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Willem Dieperink

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Medical Center Groningen

Groningen, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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I van der Meulen, PhD

Role: CONTACT

+31503615617

Other Identifiers

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COFICS201800422

Identifier Type: -

Identifier Source: org_study_id

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