Complicated Grief in ICU in the Aftermath of COVID-19

Covid19 Clinical Trial

— DEPARTS  

Official title:

Complicated Grief in ICU in the Aftermath of COVID-19

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04554264
• Other study ID #: PI2020_843_0071
• Status: Withdrawn
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: September 1, 2022

Study information

• Verified date: March 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

An increased proportion of deaths occur in the intensive care unit (ICU). Some amenable factors such as end-of-life practices may contribute to complicated grief. Because of the COVID-19 pandemic, visitor restrictions in health care facilities have been implemented. Families were also unable to implement usual funerals. The investigators hypothesize that these policies and practices may impact grief during covid-19 pandemic. The aim of this study is to evaluate the prevalence of complicated grief after death of a relative in the ICU during the COVID-19 pandemic.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult relative (>18 years)
• adult relative from patients who died in ICU after SARS-COV-2 infection

Exclusion Criteria:

• adult relative (<18 years)

Related Conditions & MeSH terms

• Complicated Grief
• COVID-19
• Covid19
• Intensive Care

Intervention

Other:
• questionnaire
Inventory of Complicate Grief (ICG) score in relative from patients who died in ICU after SARS-Cov2 infection. This is the most commonly used assessment tool for complicated grief which focuses on different symptoms than depression or anxiety. A score > 25 indicate complicated grief.

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens	University Hospital, Lille, University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of complicated grief 4 month after death in relative from patients who died in ICU after covid-19 infection evaluate with ICG score.	Proportion of complicated grief 4 month after death in relative from patients who died in ICU after covid-19 infection evaluate with ICG score.; The primary outcome measure is the Inventory of Complicate Grief (ICG) score. This is the most commonly used assessment tool for complicated grief which focuses on different symptoms than depression or anxiety. A score > 25 indicate complicated grief.; All patients who died in ICU after SARS-Cov-2 infection will be identify. Their relatives (spouse, children and relative who served as a surrogate) will also be identify. Relatives will be included up to 4 months after the time of death.	4 months after relative death
Primary	Proportion of complicated grief 6 month after death in relative from patients who died in ICU after covid-19 infection evaluate with ICG score.	Proportion of complicated grief 6 month after death in relative from patients who died in ICU after covid-19 infection evaluate with ICG score.; The primary outcome measure is the Inventory of Complicate Grief (ICG) score. This is the most commonly used assessment tool for complicated grief which focuses on different symptoms than depression or anxiety. A score > 25 indicate complicated grief.; All patients who died in ICU after SARS-Cov-2 infection will be identify. Their relatives (spouse, children and relative who served as a surrogate) will also be identify. Relatives will be included up to 6 months after the time of death.	6 months after relative covid-19 death
Primary	Proportion of complicated grief 12 month after death in relative from patients who died in ICU after covid-19 infection evaluate with ICG score.	Proportion of complicated grief 12 month after death in relative from patients who died in ICU after covid-19 infection evaluate with ICG score.; The primary outcome measure is the Inventory of Complicate Grief (ICG) score. This is the most commonly used assessment tool for complicated grief which focuses on different symptoms than depression or anxiety. A score > 25 indicate complicated grief.; All patients who died in ICU after SARS-Cov-2 infection will be identify. Their relatives (spouse, children and relative who served as a surrogate) will also be identify. Relatives will be included up to 12 months after the time of death.	12 months after relative covid-19 death