Complicated GriefDEPARTSNCT04554264
Complicated Grief in ICU in the Aftermath of COVID-19
A study testing questionnaire in people with Complicated Grief and Intensive Care, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Complicated Grief, Intensive Care, Covid19
- What is being tested?
- questionnaire
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2020to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult relative (>18 years)
- adult relative from patients who died in ICU after SARS-COV-2 infection
Who cannot join
- adult relative (<18 years)
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- questionnaire
- Keywords
- Complicated grief, Intensive Care, Covid19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12 months after relative covid-19 death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start1 Sep 2020
- Primary completion1 Sep 2021
- Study completion1 Sep 2022
Why it stopped: no participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complicated GriefStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Lille, University Hospital, Rouen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04554264
- Sponsor's protocol ID
- PI2020_843_0071
- Acronym
- DEPARTS
- Status last verified
- Mar 2023
- First submitted
- 2 Sep 2020
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complicated Grief in ICU in the Aftermath of COVID-19
- ClinicalTrials.gov ID
- NCT04554264
- Acronym / sponsor ID
- DEPARTS / PI2020_843_0071
- Conditions
- Complicated Grief, Intensive Care, Covid19
- Keywords
- Complicated grief, Intensive Care, Covid19
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- University Hospital, Lille, University Hospital, Rouen
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 18 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult relative (>18 years)
- adult relative from patients who died in ICU after SARS-COV-2 infection
Key exclusion criteria (1 listed)
- adult relative (<18 years)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaireInventory 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. | Other | – |
Primary outcome
Proportion of complicated grief 4 month after death in relative from patients who died in ICU after covid-19 infection evaluate with ICG score.
Time frame: 4 months after relative death
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.
Proportion of complicated grief 6 month after death in relative from patients who died in ICU after covid-19 infection evaluate with ICG score.
Time frame: 6 months after relative covid-19 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. 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.
Proportion of complicated grief 12 month after death in relative from patients who died in ICU after covid-19 infection evaluate with ICG score.
Time frame: 12 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. 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Complicated Grief
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Grief
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing questionnaire in people with Complicated Grief and Intensive Care, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of complicated grief 4 month after death in relative from patients who died in ICU after covid-19 infection evaluate with ICG score. (time frame: 4 months after relative death). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.