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Completed

NCT Number: NCT04498507

Psychosocial Outcomes in Families of COVID-19 ICU Patients

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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Key information

Conditions

Critical Illness Behavior Behavioral Symptoms COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Disease Attributes Family Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Psychological Stress RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Stress, Psychological Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Liège

Liège, 4000, Belgium

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

HADS questionnaire

Diagnostic Test

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

Other names: IES-R questionnaire, EQ-5D questionnaire

Primary outcomes

  1. occurence of anxiety and depression

    Time frame: one month after ICU discharge

    sub scores of HADS questionnaire >7

  2. occurence of anxiety and depression

    Time frame: three months after ICU discharge

    sub scores of HADS questionnaire >7

  3. occurence of acute stress

    Time frame: one month after ICU discharge

    IES-R score > 22

  4. occurence of post-traumatic stress disorder

    Time frame: three months after ICU discharge

    IES-R score > 36

  5. quality of life

    Time frame: one month after ICU discharge

    assessed using the EQ-5D questionnaire

  6. quality of life

    Time frame: three months after ICU discharge

    assessed using the EQ-5D questionnaire

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Official study title

Psychosocial Outcomes in Families of Patients Admitted in ICU for COVID-19 During the Pandemic in Belgium

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 4, 2020
Registry last updated
Nov 3, 2020

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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