CONDOL01: Evaluation on the Experience of Bereavement, of a Medical Consultation, Proposed by a Letter of CONDOLence to the Patients' Relatives Versus Standard Practice After the Death of the Patient: A Multicenter, Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 432
- 试验地点
- 2
- 主要终点
- Evolution of mental component score (MCS) of the SF-12 questionnaire
研究概览
简要总结
The aim of this randomized multicenter study is to evaluate the impact in offering the condolence letter to the family caregivers (indicated as the reliable person by the patient himself at each hospitalization) and a bereavement consultation with the reference physician.
详细描述
The hypothesis is that offering the opportunity to clarify questions about the patients' terminal care will influence positively the grieving process. In particular, the study team hypothesized that psychological morbidity will be reduced (main objective) as well as some aspects of QOL (secondary objective). It is also assumed that the situations of conflict (solicitations for medical records, number of legal procedures) will be reduced.
研究设计
- 研究类型
- Observational
- 观察模型
- Family Based
- 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
- 是
入选标准
- •Patient died in the institution
- •Patient for which the reliable person has been identified
- •Acceptation of the reference physician to send a letter of condolence with the proposed consultation
排除标准
- •The physician already met with the caregiver after the patient's death
研究组 & 干预措施
Group A
letter of condolence offering to the reliable person a post-death consultation with the reference physician (sent between J15 and J30 post death)
干预措施: Letter of condolence and post-death medical consultation (Behavioral)
Group B
no intervention, i.e without a letter of condolence proposing a consultation with the reference physician
结局指标
主要结局
Evolution of mental component score (MCS) of the SF-12 questionnaire
时间窗: 3 months post death
It will be evaluated by self-questionnaires send at 3 months after the death of the patient, in the 2 groups (with or without condolence letter proposing a post-death consultation).
次要结局
- Quality of life of the caregivers after the death of the patient evaluated by SF12 questionnaire(1 year post death)
- Quality of life of the caregivers after the death of the patient evaluated by specific caregivers CarGOQoL questionnaire(1 year post death)
- Anxiety of the caregivers after the death of the patient(1 year post death)
- Depression of the caregivers after the death of the patient(1 year post death)
- Complicated grief(1 year post death)