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

Primary Purpose

Psychological Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Qualitative research interview
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Psychological Disorder focused on measuring COVID19 related psychological disorders

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    population who lost a loved one during the COVID19 health crisis

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Description of the socio-demographic characteristics of the bereaved
    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided
    Exploration of the relational aspects between the bereaved, his deceased and the rest of his family circle.
    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided
    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
    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided
    Analysis of the relational dimensions between the bereaved and the healthcare team
    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided
    Exploration of support practices for the deceased (s) and funeral rites practices implemented by the bereaved
    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided
    Analysis of coping strategies and resilience factors of the bereaved person
    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided
    • Exploration of the dimensions of the lived experience and feelings of the grieving person • Exploration of the psychological state of the bereaved
    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided
    • 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)
    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided
    • 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)
    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided
    Assessment of post-traumatic symptoms in adults (Post-Traumatic Stress Disorder) (Post-traumatic stress disorder checklist version DSM-5) (PCL-5)
    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided
    • Assessment of pathological grief (Inventory of Complicated Grief - ICG)
    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided
    Connor-Davidson ResilienceScale (CD-RISC) Resilience Assessment
    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided
    Assessment of post-traumatic symptoms in adolescent Children'sRevised Impact of Events Scale (CRIES)
    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided
    Hogan Inventory Bereavement - Short Form - Children and Adolescent Mourning Scale (HIB-SF-CA)
    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided
    Adolescent Resilience Assessment Child and YouthResilienceMeasure (CYRM-R)
    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided

    Full Information

    First Posted
    June 27, 2022
    Last Updated
    October 3, 2022
    Sponsor
    Assistance Publique - Hôpitaux de Paris
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05566366
    Brief Title
    Understanding the Impact of Death Conditions Linked to the COVID-19 Crisis on the Grieving Process in Bereaved Families
    Acronym
    COVIDAAD
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2022 (Anticipated)
    Primary Completion Date
    August 2023 (Anticipated)
    Study Completion Date
    November 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Assistance Publique - Hôpitaux de Paris

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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 .
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psychological Disorder
    Keywords
    COVID19 related psychological disorders

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    population who lost a loved one during the COVID19 health crisis
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Qualitative research interview
    Intervention Description
    Qualitative research interview Administration of quantitative scales
    Primary Outcome Measure Information:
    Title
    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.
    Description
    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided
    Time Frame
    9 months
    Secondary Outcome Measure Information:
    Title
    Description of the socio-demographic characteristics of the bereaved
    Description
    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided
    Time Frame
    9 months
    Title
    Exploration of the relational aspects between the bereaved, his deceased and the rest of his family circle.
    Description
    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided
    Time Frame
    9 months
    Title
    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
    Description
    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided
    Time Frame
    9 months
    Title
    Analysis of the relational dimensions between the bereaved and the healthcare team
    Description
    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided
    Time Frame
    9 months
    Title
    Exploration of support practices for the deceased (s) and funeral rites practices implemented by the bereaved
    Description
    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided
    Time Frame
    9 months
    Title
    Analysis of coping strategies and resilience factors of the bereaved person
    Description
    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided
    Time Frame
    9 months
    Title
    • Exploration of the dimensions of the lived experience and feelings of the grieving person • Exploration of the psychological state of the bereaved
    Description
    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided
    Time Frame
    9 months
    Title
    • 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)
    Description
    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided
    Time Frame
    9 months
    Title
    • 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)
    Description
    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided
    Time Frame
    9 months
    Title
    Assessment of post-traumatic symptoms in adults (Post-Traumatic Stress Disorder) (Post-traumatic stress disorder checklist version DSM-5) (PCL-5)
    Description
    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided
    Time Frame
    9 months
    Title
    • Assessment of pathological grief (Inventory of Complicated Grief - ICG)
    Description
    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided
    Time Frame
    9 months
    Title
    Connor-Davidson ResilienceScale (CD-RISC) Resilience Assessment
    Description
    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided
    Time Frame
    9 months
    Title
    Assessment of post-traumatic symptoms in adolescent Children'sRevised Impact of Events Scale (CRIES)
    Description
    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided
    Time Frame
    9 months
    Title
    Hogan Inventory Bereavement - Short Form - Children and Adolescent Mourning Scale (HIB-SF-CA)
    Description
    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided
    Time Frame
    9 months
    Title
    Adolescent Resilience Assessment Child and YouthResilienceMeasure (CYRM-R)
    Description
    In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided
    Time Frame
    9 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Carla DE STEFANO, Dr
    Phone
    +33148 96 44 61
    Email
    carla.destefano@aphp.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zahia BEN ABDESSELAM, PM
    Phone
    +331 48 95 74 35
    Email
    zahia.ben-abdesselam@aphp.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Carla DE STEFANO, Dr
    Organizational Affiliation
    Avicenne Hospital-APHP
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32799105
    Citation
    Xiong J, Lipsitz O, Nasri F, Lui LMW, Gill H, Phan L, Chen-Li D, Iacobucci M, Ho R, Majeed A, McIntyre RS. Impact of COVID-19 pandemic on mental health in the general population: A systematic review. J Affect Disord. 2020 Dec 1;277:55-64. doi: 10.1016/j.jad.2020.08.001. Epub 2020 Aug 8.
    Results Reference
    background
    PubMed Identifier
    24068457
    Citation
    Shear MK, Ghesquiere A, Glickman K. Bereavement and complicated grief. Curr Psychiatry Rep. 2013 Nov;15(11):406. doi: 10.1007/s11920-013-0406-z.
    Results Reference
    background
    PubMed Identifier
    32298748
    Citation
    Wallace CL, Wladkowski SP, Gibson A, White P. Grief During the COVID-19 Pandemic: Considerations for Palliative Care Providers. J Pain Symptom Manage. 2020 Jul;60(1):e70-e76. doi: 10.1016/j.jpainsymman.2020.04.012. Epub 2020 Apr 13.
    Results Reference
    background
    PubMed Identifier
    21216470
    Citation
    Kersting A, Brahler E, Glaesmer H, Wagner B. Prevalence of complicated grief in a representative population-based sample. J Affect Disord. 2011 Jun;131(1-3):339-43. doi: 10.1016/j.jad.2010.11.032. Epub 2011 Jan 8.
    Results Reference
    background
    PubMed Identifier
    33414728
    Citation
    Demartini B, Nistico V, D'Agostino A, Priori A, Gambini O. Early Psychiatric Impact of COVID-19 Pandemic on the General Population and Healthcare Workers in Italy: A Preliminary Study. Front Psychiatry. 2020 Dec 22;11:561345. doi: 10.3389/fpsyt.2020.561345. eCollection 2020.
    Results Reference
    background
    PubMed Identifier
    32112714
    Citation
    Brooks SK, Webster RK, Smith LE, Woodland L, Wessely S, Greenberg N, Rubin GJ. The psychological impact of quarantine and how to reduce it: rapid review of the evidence. Lancet. 2020 Mar 14;395(10227):912-920. doi: 10.1016/S0140-6736(20)30460-8. Epub 2020 Feb 26.
    Results Reference
    background

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

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