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Completed

NCT Number: NCT04460170

COVID-19 Follow up Intensive Care Studies

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.

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Key information

Conditions

Quality of Life COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. General Health

    Time frame: 3 months post ICU discharge

    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.

  2. General Health

    Time frame: 6 months post ICU discharge

    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. General Health

    Time frame: 12 months post ICU discharge

    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.

  4. Anxiety and Depression

    Time frame: 3 months post ICU discharge

    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.

  5. Anxiety and Depression

    Time frame: 6 months post ICU discharge

    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. Anxiety and Depression

    Time frame: 12 months post ICU discharge

    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.

  7. Long function

    Time frame: 6 months post ICU discharge (only in patients)

    Spirometry test

  8. Long function

    Time frame: 12 months post ICU discharge (only in patients)

    Spirometry test

  9. Frailty

    Time frame: 3 months post ICU discharge (only in patients)

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

  10. Frailty

    Time frame: 6 months post ICU discharge (only in patients)

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

  11. Frailty

    Time frame: 12 months post ICU discharge (only in patients)

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

  12. Family functioning

    Time frame: 6 months post ICU discharge

    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.

  13. Family functioning

    Time frame: 12 months post ICU discharge

    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.

  14. Effect of an ICU admission on return to work

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

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

  15. Effect of an ICU admission on return to work

    Time frame: 6 months post ICU discharge

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

  16. Effect of an ICU admission on return to work

    Time frame: 12 months post ICU discharge

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

Secondary outcomes

  1. age

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

    age (years)

  2. Gender

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

    Gender (male/female)

  3. Social status

    Time frame: 3 months post ICU discharge

    Social status (married/living together/ single)

  4. APACHE IV

    Time frame: 24 hours (only in patients)

    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

  5. Comorbidity

    Time frame: 3 months post ICU discharge (only in patients)

    Comorbidity ( free text)

  6. Body mass index

    Time frame: 3 months post ICU discharge (only in patients)

    Body mass index (kg/m2)

  7. ICU stay

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

    ICU stay (days)

  8. Mechanical ventilation

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

    Mechanical ventilation (days)

  9. Delerium

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

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

  10. Hospital stay

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

    Hospital stay (days)

  11. Discharge locationn

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

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

  12. Mortality

    Time frame: 3 months post ICU discharge (only in patients)

    Mortality (no / yes --> date)

  13. Mortality

    Time frame: 6 months post ICU discharge (only in patients)

    Mortality (no / yes --> date)

  14. Mortality

    Time frame: 12 months post ICU discharge (only in patients)

    Mortality (no / yes --> date)

  15. Relationship with the patient

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

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

  16. Educational level

    Time frame: 3 months post ICU discharge

    Educational level (low, middle, high)

  17. Readmission

    Time frame: 3 months post ICU discharge (only in patients)

    Readmission (no / yes --> free text)

  18. Health care consumption

    Time frame: 3 months post ICU discharge

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

  19. Health care consumption

    Time frame: 6 months post ICU discharge

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

  20. Health care consumption

    Time frame: 12 months post ICU discharge

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

  21. Weight

    Time frame: 3 months post ICU discharge

    Weight (kg)

  22. Weight

    Time frame: 6 months post ICU discharge

    Weight (kg)

  23. Weight

    Time frame: 12 months post ICU discharge

    Weight (kg)

  24. Hypertensive

    Time frame: 3 months post ICU discharge

    Hypertensive (RR)

  25. Hypertensive

    Time frame: 6 months post ICU discharge

    Hypertensive (RR)

  26. Hypertensive

    Time frame: 12 months post ICU discharge

    Hypertensive (RR)

  27. Thrombosis

    Time frame: 3 months post ICU discharge

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

  28. Thrombosis

    Time frame: 6 months post ICU discharge

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

  29. Thrombosis

    Time frame: 12 months post ICU discharge

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

  30. Diabetes

    Time frame: 3 months post ICU discharge

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

  31. Diabetes

    Time frame: 6 months post ICU discharge

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

  32. Diabetes

    Time frame: 12 months post ICU discharge

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

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • Hanze University of Applied Sciences Groningen

Registry information

Acronym: COFICS

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 7, 2020
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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