COVIDAAD: Understanding the Impact of Death Conditions Linked to the COVID-19 Crisis on the Grieving Process in Bereaved Families

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05566366
Collaborator
(none)
100
1
13

Study Details

Study Description

Brief Summary

This study aims to analyze the grieving process of people who have lost a close first degree relative, understand the impact of death conditions and model a "theory of mourning" in the context of the COVID-19 crisis .

Condition or Disease Intervention/Treatment Phase
  • Other: Qualitative research interview
N/A

Detailed Description

The COVID-19 pandemic has confronted us with an unprecedented health crisis, this had major consequences on mental health . International literature has already shown an increase in psychological and psychiatric distress in patients followed in psychiatry, and in the general population.

For bereaved relatives, certain factors contribute to complicate the mourning process, such as: the absence of communication with the healthcare team, the prohibition of visits, the absence of funeral rites... In the proposed research, we will analyze the grieving process of people who have lost a close first degree relative in children and adolescents population, understand the repercussions conditions of death in bereaved families and model a "theory of mourning" in the context of the current epidemic health crisis.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Understanding the Impact of Death Conditions Linked to the COVID-19 Health Crisis on the Grieving Process in Bereaved Families (Adolescents and Adults): a Qualitative Study
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: population who lost a loved one during the COVID19 health crisis

Analyze the grieving process of people who have lost a close first degree relative, understand the impact of death conditions on this process and model a "theory of mourning" in the context of the actual epidemic health crisis.

Other: Qualitative research interview
Qualitative research interview Administration of quantitative scales

Outcome Measures

Primary Outcome Measures

  1. Identify the most traumatic aspects for bereaved families and better identify risk factors that may complicate the grieving process and contribute to the development of possible psychopathology. [9 months]

    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided

Secondary Outcome Measures

  1. Description of the socio-demographic characteristics of the bereaved [9 months]

    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided

  2. Exploration of the relational aspects between the bereaved, his deceased and the rest of his family circle. [9 months]

    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided

  3. Exploration of the history of the disease (Covid-19 and not Covid-19) and care management (extra-hospital and / or intra-hospital) until the announcement of the death [9 months]

    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided

  4. Analysis of the relational dimensions between the bereaved and the healthcare team [9 months]

    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided

  5. Exploration of support practices for the deceased (s) and funeral rites practices implemented by the bereaved [9 months]

    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided

  6. Analysis of coping strategies and resilience factors of the bereaved person [9 months]

    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided

  7. • Exploration of the dimensions of the lived experience and feelings of the grieving person • Exploration of the psychological state of the bereaved [9 months]

    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided

  8. • Exploration of the bereaved person's experience of reporting the epidemic in the media and the COVID-19 disease (whether or not they have contracted it) [9 months]

    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided

  9. • Assessment of pathological grief (Inventory of Complicated Grief - ICG) • Connor-Davidson ResilienceScale (CD-RISC) Resilience Assessment • Assessment of post-traumatic symptoms in adolescent Children'sRevised Impact of Events Scale (CRIES) [9 months]

    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided

  10. Assessment of post-traumatic symptoms in adults (Post-Traumatic Stress Disorder) (Post-traumatic stress disorder checklist version DSM-5) (PCL-5) [9 months]

    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided

  11. • Assessment of pathological grief (Inventory of Complicated Grief - ICG) [9 months]

    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided

  12. Connor-Davidson ResilienceScale (CD-RISC) Resilience Assessment [9 months]

    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided

  13. Assessment of post-traumatic symptoms in adolescent Children'sRevised Impact of Events Scale (CRIES) [9 months]

    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided

  14. Hogan Inventory Bereavement - Short Form - Children and Adolescent Mourning Scale (HIB-SF-CA) [9 months]

    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided

  15. Adolescent Resilience Assessment Child and YouthResilienceMeasure (CYRM-R) [9 months]

    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Bereaved person who lost a close relative (child, adolescent, adult) since March 2020

  • Age over 15 years old

  • First degree relative (husband-wife or equivalent, father-mother, son-daughter, brother-sister)

  • A bereaved person who is in at least one of the following conditions:

  • Unable to visit the hospital if hospitalized OR

  • Unable to travel to the home/EPHAD/hospital OR

  • Wish not to travel for personal reasons OR

  • Failure to perform funeral rites OR

  • Failure to respect the wishes of the deceased and his or her own wishes OR

  • Inability to see the deceased OR

  • Opportunity to participate in the funeral OR

  • Unable to say goodbye OR

  • Inability to communicate via telephone and/or smartphone OR

  • Unable to repatriate the body to the country or region of origin

  • Relative who died (child, adolescent, adult) between March 2020 and March 2021 with Covid-19 or other life-threatening conditions

  • Relative who died in an inpatient or outpatient setting (EPHAD, home or other structure)

  • French or non-French speaking bereaved person

Exclusion Criteria:

-Presence of a pathology preventing good elocution during the interview

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Carla DE STEFANO, Dr, Avicenne Hospital-APHP

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT05566366
Other Study ID Numbers:
  • APHP210638
First Posted:
Oct 4, 2022
Last Update Posted:
Oct 4, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Assistance Publique - Hôpitaux de Paris
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 4, 2022