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Psychosocial Outcomes in Families of COVID-19 ICU Patients

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ClinicalTrials.gov Identifier: NCT04498507
Recruitment Status : Completed
First Posted : August 4, 2020
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
Rousseau, University of Liege

Brief 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.

Condition or disease Intervention/treatment
Critical Illness Family Psychological Stress Covid19 Diagnostic Test: HADS questionnaire

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Study Type : Observational
Actual Enrollment : 39 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Psychosocial Outcomes in Families of Patients Admitted in ICU for COVID-19 During the Pandemic in Belgium
Actual Study Start Date : April 16, 2020
Actual Primary Completion Date : October 30, 2020
Actual Study Completion Date : October 30, 2020

Intervention Details:
  • Diagnostic Test: HADS questionnaire
    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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04498507


Locations
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Belgium
University Hospital of Liège
Liège, Belgium, 4000
Sponsors and Collaborators
University of Liege
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Responsible Party: Rousseau, MD, PhD, University of Liege
ClinicalTrials.gov Identifier: NCT04498507    
Other Study ID Numbers: Family COVID
First Posted: August 4, 2020    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Critical Illness
Stress, Psychological
Disease Attributes
Pathologic Processes
Behavioral Symptoms