Psychosocial Outcomes in Families of COVID-19 ICU Patients

NCT04498507 | Completed

• 1 other identifier: Family COVID
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Family; Psychological Stress; Covid19

Outcome Measures

Primary Outcomes (6)

• 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

Interventions

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Liege: lead

Study Sites (1)

University Hospital of Liège

Liège, 4000, Belgium

Location

MeSH Terms

Conditions

Critical Illness; Stress, Psychological; COVID-19

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 1, 2020
• First Posted: August 4, 2020
• Study Start: April 16, 2020
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: November 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)