Psychosocial Outcomes in Families of COVID-19 ICU Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Covid19; Psychological Stress; Family
• Intervention / Treatment: Diagnostic test: HADS questionnaire

• Study Type: Observational
• Enrollment (Actual): 39

Contacts and Locations

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • University Hospital of Liege

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
occurence of anxiety and depression	sub scores of HADS questionnaire >7	one month after ICU discharge
occurence of anxiety and depression	sub scores of HADS questionnaire >7	three months after ICU discharge
occurence of acute stress	IES-R score > 22	one month after ICU discharge
occurence of post-traumatic stress disorder	IES-R score > 36	three months after ICU discharge
quality of life	assessed using the EQ-5D questionnaire	one month after ICU discharge
quality of life	assessed using the EQ-5D questionnaire	three months after ICU discharge

Collaborators and Investigators

• Sponsor: University of Liege

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2020
• Primary Completion (Actual): October 30, 2020
• Study Completion (Actual): October 30, 2020

Study Registration Dates

• First Submitted: August 1, 2020
• First Submitted That Met QC Criteria: August 3, 2020
• First Posted (Actual): August 4, 2020

Study Record Updates

• Last Update Posted (Actual): November 3, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Stress, Psychological; Critical Illness
• Other Study ID Numbers: Family COVID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No