Psychosocial Outcomes in Families of COVID-19 ICU Patients

• Sponsor: University of Liege (Other)
• Overall Status: Completed
• CT.gov ID: NCT04498507
• Collaborator: (none)
• Enrollment: 39
• Location: 1
• Actual Duration (Months): 6.5
• Patients Per Site Per Month: 6

Study Details

Study Description

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	Phase
Critical Illness; Family; Psychological Stress; Covid19	Diagnostic Test: HADS questionnaire

Study Design

• 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: Apr 16, 2020
• Actual Primary Completion Date: Oct 30, 2020
• Actual Study Completion Date: Oct 30, 2020

Outcome Measures

Primary Outcome Measures

1. occurence of anxiety and depression [one month after ICU discharge]

   sub scores of HADS questionnaire >7

2. occurence of anxiety and depression [three months after ICU discharge]

   sub scores of HADS questionnaire >7

3. occurence of acute stress [one month after ICU discharge]

   IES-R score > 22

4. occurence of post-traumatic stress disorder [three months after ICU discharge]

   IES-R score > 36

5. quality of life [one month after ICU discharge]

   assessed using the EQ-5D questionnaire

6. quality of life [three months after ICU discharge]

   assessed using the EQ-5D questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Liège	Liège		Belgium	4000

Sponsors and Collaborators

• University of Liege

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rousseau, MD, PhD, University of Liege
• ClinicalTrials.gov Identifier: NCT04498507
• Other Study ID Numbers: Family COVID
• First Posted: Aug 4, 2020
• Last Update Posted: Nov 3, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19; Critical Illness; Stress, Psychological

Study Results

No Results Posted as of Nov 3, 2020