Incidence and Risk Factors of Prolonged Grief in Palliative Care Units

Completed

• Conditions: Bereaved Families

• Registration Number: NCT03748225
• Lead Sponsor: Hôpital Franco-Britannique-Fondation Cognacq-Jay

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.

Study Timeline

• Study First Submitted: 2018-11-19
• Study First Submitted QC: 2018-11-19
• Study First Posted: 2018-11-20
• Study Start: 2019-02-04
• Status Verified: 2020-01
• Primary Completion: 2020-10-01
• Study Completion: 2021-02-10
• Last Update Submitted: 2021-02-10
• Last Update Posted: 2021-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 609

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Risk factors of prolonged grief in bereaved family members	6 months after patient's death in palliative care unit	Hierarchical logistic regression models with a random effect center after selection of variables by univariate analysis then introduced in a multivariate analysis
Incidence of prolonged grief in bereaved family members	6 months after patient's death in palliative care unit	Inventory Grief Disorder \> 25

Secondary Outcome Measures

Name	Time	Method
Anxiety and depression symptoms in bereaved family members	6 months after patient's death in palliative care unit	Hospital anxiety and depression scale ≥ 8
Post traumatic stress disorder in bereaved family members	6 months after patient's death in palliative care unit	Impact of event Scale-revised \> 22
Anxiety and depression symptoms in family members	Between between day 3 and day 5 after patient admission in the palliative care unit	Hospital 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 > 25	Between 6 and 12 months after the patient' death.	Interpretative Phenomenological Analysis

Trial Locations

Locations (1)

French British Institute; 🇫🇷 Levallois-Perret, France