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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 609
- 试验地点
- 1
- 主要终点
- Risk factors of prolonged grief in bereaved family members
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Risk factors of prolonged grief in bereaved family members
时间窗: 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
时间窗: 6 months after patient's death in palliative care unit
Inventory Grief Disorder \> 25
次要结局
- Anxiety and depression symptoms in bereaved family members(6 months after patient's death in palliative care unit)
- Post traumatic stress disorder in bereaved family members(6 months after patient's death in palliative care unit)
- Anxiety and depression symptoms in family members(Between between day 3 and day 5 after patient admission in the palliative care unit)
- 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.)
研究者
Maité Garrouste-Orgeas, MD
Director, head of clinical research, principal investigator, medical doctor
Hôpital Franco-Britannique-Fondation Cognacq-Jay