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Expression of a Need of Implication for the Vulnerable Patient and His Adaptation (EIVA)

2019年5月15日 更新者:Hopital Foch
The aim of the research is to detect prematurely vulnerable patients needing a global coverage in integrated care with a created and metrological validated score.

研究概览

地位

终止

条件

详细说明

The respect for the rights of the patients in palliative phase - having an evolutionary or terminal grave pathology - is a legal requirement since 1999, strengthened by the laws of April 4th, 2002 and April 22nd, 2005. Nevertheless, a lack of palliative approach persists, that is premature awareness of the necessity of a global approach, not exclusively centred on the specific therapeutics. The palliative approach remains rare and especially most of the time reduced in the last days of the life. The lack of distribution of the legal texts and insufficient training are among the main reasons. The lack of educational tools is probably also a major brake in a premature reflection.

Primary objective : to detect prematurely vulnerable patients needing a global coverage in integrated care with a created and metrological validated score.

Primary endpoint: capacity of the score to be discriminated (area under the curve) to find the patients who need or not a palliative approach

Secondary objectives:

  • The measure of the relevance of the tests of quality of life, personality traits, level of information and anxiety depression to detect prematurely the vulnerable patients and/or their family caregivers who need an approach of palliative care in integrated care;
  • The detail (date, nature of the event) of the various stages of their life course, during which the vulnerable patients needing a premature global care were taken care within the framework of such an approach, compared with their theoretical detection by the score of premature detection scale;
  • The evaluation of the concordance between the patient score and the family caregiver score, if he participates in the research.

Secondary endpoints:

  • The tests estimating the anxiety and the depression ( HAD (Hospital Anxiety and Depression) score), the personality and adaptation traits, Brief Cope;
  • The quality of life tests EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire) and level of information EORTC INF-30 (Information-30) for the cancer patients;
  • The deadline between detection by the score and effective global care
  • The deadline between detection by the score and the cessation of the specific treatments
  • The deadline between detection by the score and the death
  • The patient and close scores obtained in the validation phase.

Methods: Prospective, controlled, nonrandomized study

Number of patients to include: 610 (maximum)

Duration: 36 months (32 inclusion months).

Number of participating centers: 1 center

研究类型

介入性

注册 (实际的)

32

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Suresnes、法国、92150
        • Hôpital Foch

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • All patients hospitalized with:

    • an evolutionary incurable disease;
    • Taken care for more than a month by the health care team palliatives EIVA (except for the last 200 patients, for whom the deadline extension of palliative care is lower that 6 days);
    • Benefiting of asocial scheme or claimant
    • Having signed the informed consent as well as his(her) family caregiver, if this one participates in the research.

The absence of family caregiver is not an exclusion criterion.

Exclusion Criteria:

  • Patient:

    • Having difficulty of understanding of the French language
    • Having a life expectancy estimated unless one month
    • un controlled physical or psychic distress (anxiety and/or depression)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Group A
Elaboration of the questionnaires
实验性的:Group B
Patients taken care for more less than 6 days by the health care team palliatives EIVA and they eventual family caregiver. Score

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Capacity of the score to be discriminated (area under the curve) to find the patients who need or not a palliative approach
大体时间:15 days
15 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 首席研究员:Edouard FERRAND, MD、Hôpital Foch

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年1月1日

初级完成 (实际的)

2019年3月1日

研究完成 (实际的)

2019年3月1日

研究注册日期

首次提交

2016年9月9日

首先提交符合 QC 标准的

2016年9月9日

首次发布 (估计)

2016年9月14日

研究记录更新

最后更新发布 (实际的)

2019年5月17日

上次提交的符合 QC 标准的更新

2019年5月15日

最后验证

2019年5月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • 2014/27
  • 2014-A01386-41 (其他标识符:ANSM)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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