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CompletedNCT04498507Updated Nov 3, 2020

Psychosocial Outcomes in Families of COVID-19 ICU Patients

An observational study in Critical Illness, Family and Psychological Stress, sponsored by University of Liege. Completed at 1 site in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-03.

Sponsored by University of Liege · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
39
Ages
18 Years and older
Sex
All
01

Study summary

During the first part of the SRAS-COV2 pandemic, families were not allowed to visit the patients in ICU. We know that families can develop "Family-PICS" after their relatives' ICU stay. The aim of the study is to study the psychosocial outcomes of families of patients who were admitted in ICU for COVID-19 during the pandemic. The second objective was to search for any differences in outcomes whether families benefited from video-conferences with the medical team and their relatives or not during the ICU stay.

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Conditions studied

  • Critical Illness
  • Family
  • Psychological Stress
  • Covid19
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In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 39 is below the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

University of Liege is the lead sponsor of 242 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

this study includes the family members of patients who were admitted in ICU for sever COVID-19 during the first part of the pandemic when visits in ICU were not allowed

Inclusion criteria

  • the referent family member of any patient admitted in ICU for COVID-19 during the first part of the pandemic

Exclusion criteria

Exclusion Criteria:

  • cognitive disorders
  • not French-speaking
  • refusal to participate
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
39 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testHADS questionnaire

    Patients will be asked to answer to 3 questionnaires about anxiety and depression, post-traumatic stress disorder and health-related quality of life

    Also known as: IES-R questionnaire, EQ-5D questionnaire

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What researchers measure

Primary outcomes

  1. occurence of anxiety and depression

    sub scores of HADS questionnaire \>7

    Time frame: one month after ICU discharge

  2. occurence of anxiety and depression

    sub scores of HADS questionnaire \>7

    Time frame: three months after ICU discharge

  3. occurence of acute stress

    IES-R score \> 22

    Time frame: one month after ICU discharge

  4. occurence of post-traumatic stress disorder

    IES-R score \> 36

    Time frame: three months after ICU discharge

  5. quality of life

    assessed using the EQ-5D questionnaire

    Time frame: one month after ICU discharge

  6. quality of life

    assessed using the EQ-5D questionnaire

    Time frame: three months after ICU discharge

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Study locations

1 site
  • University Hospital of Liège
    Liège, 4000, Belgium
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04498507
Lead sponsor
University of Liege
Responsible party
Rousseau (MD, PhD, University of Liege) — Principal investigator
First posted
Aug 4, 2020
Start date
Apr 16, 2020
Primary completion
Oct 30, 2020
Completion
Oct 30, 2020
Last update
Nov 3, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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