Complicated Grief in ICU in the Aftermath of COVID-19

NCT04554264 | Withdrawn

• 1 other identifier: PI2020_843_0071
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Complicated Grief; Intensive Care; Covid19

Keywords

Complicated grief; Intensive Care; Covid19

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Interventions

questionnaire OTHER

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.

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• adult relative (\<18 years)

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead
• University Hospital, Lille: collaborator
• University Hospital, Rouen: collaborator

Study Sites (1)

CHU Amiens

Amiens, 80480, France

Location

MeSH Terms

Conditions

COVID-19

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: September 18, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2022
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)