Psychosocial Outcomes in Families of COVID-19 ICU Patients

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04498507
• Other study ID #: Family COVID
• Status: Completed
• Start date: April 16, 2020
• Est. completion date: October 30, 2020

Study information

• Verified date: November 2020
• Source: University of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: October 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• Critical Illness
• Family
• Psychological Stress
• Stress, Psychological

Intervention

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

Locations

Country	Name	City	State
Belgium	University Hospital of Liège	Liège

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

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