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Incidence and Risk Factors of Prolonged Grief in Palliative Care Units

The Fami-Life Study: Protocol of a Prospective Multicenter Observational Mixed Study of Psychological Consequences of Grieving Families in French Palliative Care Units on the Behalf of the F.R.I.P.C Research Network

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03748225
Acronym
FAMI-LIFE
Enrollment
609
Registered
2018-11-20
Start date
2019-02-04
Completion date
2021-02-10
Last updated
2021-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bereaved Families

Brief summary

The purpose of this study is to assess the incidence and risk factors of prolonged grief in family members of patients died in French palliative care units and to explore experience of bereaved families to build a scientifically valid management prevention program.

Detailed description

There is hardly knowledge on how bereavement is treated in palliative care patient's relatives. The field of bereavement needs studies that validate the theoretical underpinning of the research area. This study will depict the grieving process of individuals having lost a relative in palliative care in France. Having baseline data of incidence of prolonged grief, risk factors of relative's prolonged grief and identification of risk factors associated with the management of end-of-life issues in palliative care will contribute to target interventions that should help decrease bereaved families burden. The investigator designed a quantitative study to assess the psychological effect of families after the death of the patient in palliative care unit and a qualitative study to examine the grieving prolonged process.

Interventions

None listed

Sponsors

Fondation de France
CollaboratorOTHER
Hôpital Franco-Britannique-Fondation Cognacq-Jay
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Families of adult patients hospitalized more than 72 hours in a palliative care unit for end-of-life care. * Eligibility of end-of-life cares are defined after the first evaluation by the palliative care physician.

Exclusion criteria

* Patients with less than 72 hours of life-expectancy * Patients or families who refused the study * Patients or families included in a study using the same questionnaires * Patients without families visiting them in the first 24 hours after admission * Patients not hospitalized for end-of-life issues * Families not fluent in French * Deaf or mute families

Design outcomes

Primary

MeasureTime frameDescription
Incidence of prolonged grief in bereaved family members6 months after patient's death in palliative care unitInventory Grief Disorder \> 25
Risk factors of prolonged grief in bereaved family members6 months after patient's death in palliative care unitHierarchical logistic regression models with a random effect center after selection of variables by univariate analysis then introduced in a multivariate analysis

Secondary

MeasureTime frameDescription
Post traumatic stress disorder in bereaved family members6 months after patient's death in palliative care unitImpact of event Scale-revised \> 22
Anxiety and depression symptoms in bereaved family members6 months after patient's death in palliative care unitHospital anxiety and depression scale ≥ 8
Anxiety and depression symptoms in family membersBetween between day 3 and day 5 after patient admission in the palliative care unitHospital anxiety and depression scale ≥ 8
Report of the families' grief experience in those who have signs of prolonged grief according to the Inventory of Complicated Grief questionnaire with a score > 25Between 6 and 12 months after the patient' death.Interpretative Phenomenological Analysis

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026