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Quality of LifeCOFICSNCT04460170

COVID-19 Follow up Intensive Care Studies

An observational study of Quality of Life and COVID-19, run by University Medical Center Groningen at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Quality of Life, COVID-19
How many people
122 participants
Where
1 siteNetherlands
Study dates
1 Jul 2020to 1 Feb 2022
How long will I take part?
12 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • ≥ 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)

Who cannot join

  • Refuse to participate
  • Serious language barrier
  • Cognitive impairment
  • Severe psychiatric disorder
  • Chronic ventilator dependency (only in patients)

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • University Medical Center Groningen

    Groningen, 9700 RB

Other trials in Netherlands

About this study

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.

Read the 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.

Keywords
Critical Care, Family Members, Patients, Follow-Up Studies, Quality of Life, COVID-19
Medical subject headings
COVID-19

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months post ICU discharge

  2. 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.

    Measured: 6 months post ICU discharge

  3. 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.

    Measured: 12 months post ICU discharge

  4. 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.

    Measured: 3 months post ICU discharge

  5. 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.

    Measured: 6 months post ICU discharge

  6. 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.

    Measured: 12 months post ICU discharge

  7. Long function

    Spirometry test

    Measured: 6 months post ICU discharge (only in patients)

  8. Long function

    Spirometry test

    Measured: 12 months post ICU discharge (only in patients)

  9. Frailty

    Clinical Frailty Scale with a single outcome measure summarizing the overall level of fitness.

    Measured: 3 months post ICU discharge (only in patients)

  10. Frailty

    Clinical Frailty Scale with a single outcome measure summarizing the overall level of fitness.

    Measured: 6 months post ICU discharge (only in patients)

  11. Frailty

    Clinical Frailty Scale with a single outcome measure summarizing the overall level of fitness.

    Measured: 12 months post ICU discharge (only in patients)

  12. 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.

    Measured: 6 months post ICU discharge

  13. 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.

    Measured: 12 months post ICU discharge

  14. Effect of an ICU admission on return to work

    Return to work knowing; possible job loss, change of work activities and worsening employment status

    Measured: 3 months post ICU discharge (only in family members)

  15. Effect of an ICU admission on return to work

    Return to work knowing; possible job loss, change of work activities and worsening employment status

    Measured: 6 months post ICU discharge

  16. Effect of an ICU admission on return to work

    Return to work knowing; possible job loss, change of work activities and worsening employment status

    Measured: 12 months post ICU discharge

Secondary outcomes (32)

  1. age

    age (years)

    Measured: 24 hours (patient) / 3 months post ICU discharge (family member)

  2. Gender

    Gender (male/female)

    Measured: 24 hours (patient) / 3 months post ICU discharge (family member)

  3. Social status

    Social status (married/living together/ single)

    Measured: 3 months post ICU discharge

  4. 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

    Measured: 24 hours (only in patients)

  5. Comorbidity

    Comorbidity ( free text)

    Measured: 3 months post ICU discharge (only in patients)

  6. Body mass index

    Body mass index (kg/m2)

    Measured: 3 months post ICU discharge (only in patients)

  7. ICU stay

    ICU stay (days)

    Measured: hospital discharge, an average of 4 weeks (only in patients)

  8. Mechanical ventilation

    Mechanical ventilation (days)

    Measured: hospital discharge, an average of 4 weeks (only in patients)

  9. Delerium

    Delerium (no / yes --> CAM-ICU / DOS score)

    Measured: hospital discharge, an average of 4 weeks (only in patients)

  10. Hospital stay

    Hospital stay (days)

    Measured: hospital discharge, an average of 4 weeks (only in patients)

  11. Discharge locationn

    Discharge location (home, other hospital, nursing home, revelidation center)

    Measured: hospital discharge, an average of 4 weeks (only in patients)

  12. Mortality

    Mortality (no / yes --> date)

    Measured: 3 months post ICU discharge (only in patients)

  13. Mortality

    Mortality (no / yes --> date)

    Measured: 6 months post ICU discharge (only in patients)

  14. Mortality

    Mortality (no / yes --> date)

    Measured: 12 months post ICU discharge (only in patients)

  15. Relationship with the patient

    Relationship with the patient (Partner, sibling, child, other)

    Measured: 3 months post ICU discharge (only in family members)

  16. Educational level

    Educational level (low, middle, high)

    Measured: 3 months post ICU discharge

  17. Readmission

    Readmission (no / yes --> free text)

    Measured: 3 months post ICU discharge (only in patients)

  18. Health care consumption

    Health care consumption (general practicionar, home care, physiotherapist, lung specialist, psychologist, onther (free text))

    Measured: 3 months post ICU discharge

  19. Health care consumption

    Health care consumption (general practicionar, home care, physiotherapist, lung specialist, psychologist, onther (free text))

    Measured: 6 months post ICU discharge

  20. Health care consumption

    Health care consumption (general practicionar, home care, physiotherapist, lung specialist, psychologist, onther (free text))

    Measured: 12 months post ICU discharge

  21. Weight

    Weight (kg)

    Measured: 3 months post ICU discharge

  22. Weight

    Weight (kg)

    Measured: 6 months post ICU discharge

  23. Weight

    Weight (kg)

    Measured: 12 months post ICU discharge

  24. Hypertensive

    Hypertensive (RR)

    Measured: 3 months post ICU discharge

  25. Hypertensive

    Hypertensive (RR)

    Measured: 6 months post ICU discharge

  26. Hypertensive

    Hypertensive (RR)

    Measured: 12 months post ICU discharge

  27. Thrombosis

    Thrombosis (no / yes --> anticoagulant, DVT or PE)

    Measured: 3 months post ICU discharge

  28. Thrombosis

    Thrombosis (no / yes --> anticoagulant, DVT or PE)

    Measured: 6 months post ICU discharge

  29. Thrombosis

    Thrombosis (no / yes --> anticoagulant, DVT or PE)

    Measured: 12 months post ICU discharge

  30. Diabetes

    Diabetes (no /yes --> current insulin level, metformin/ insulin use)

    Measured: 3 months post ICU discharge

  31. Diabetes

    Diabetes (no /yes --> current insulin level, metformin/ insulin use)

    Measured: 6 months post ICU discharge

  32. Diabetes

    Diabetes (no /yes --> current insulin level, metformin/ insulin use)

    Measured: 12 months post ICU discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2020
  2. Study start1 Jul 2020
  3. Primary completion1 Feb 2022
  4. Study completion1 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
122 participants (actual)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04460170
Sponsor's protocol ID
COFICS201800422
Acronym
COFICS
Status last verified
May 2026
First submitted
29 Jun 2020
Last updated
26 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Quality of Life and COVID-19, run by University Medical Center Groningen at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

General Health (time frame: 3 months post ICU discharge). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04460170.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.

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