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临床试验/NCT02521740
NCT02521740Unknown不适用

Soutien Des Soins Informels Aux Personnes âgées Fragiles : Accompagnement Des Aidants Sur Base d'Une évaluation Clinique et Biologique de la Charge de Soins.

Centre Hospitalier Universitaire UCLouvain Namur1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
1
主要终点
Levels of biomarkers across groups

研究概览

简要总结

Providing care for a disabled elderly may represent a risk for the health of the caregiver. The objective of the study is to assess the impact of caregiving in terms of clinical and biological markers in relation to disability and cognitive impairment.

详细描述

The investigators hypothesize that an accumulation of stressful events related to care giving may induce a stress response to the caregiver. This stress response can be measured by biological markers (inflammation, transcription and immunity) and also by clinical markers (frailty, physical performance, nutrition). This stress response can be influenced by the subjective burden of the caregiver and by the severity of the disease of the care receiver (Activity of daily life capabilities, cognitive function, behavioral disturbance).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
70 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • living with the care-receiver ( or with a healthy elderly for the controls)
  • care-receiver dependent for at least one Activity of the daily living ( Katz index) or having cognitive disorder ( >2 Global Deterioration Scale)

排除标准

  • institutionalised elderly
  • inability to understand and speak french
  • Acute disease within the past month
  • Anti-inflammatory or immuno-suppressive treatment
  • End-of-life care

结局指标

主要结局

Levels of biomarkers across groups

时间窗: at baseline

biomarkers of inflammation (cortisol, high sensitive C-Reactive Protein,Interleukin-6), immunity (TRECS, telomere length) and transcriptomics/epigenetics

次要结局

  • Relation between biomarkers, subjective burden and the care receiver situation(at baseline)

研究者

发起方
Centre Hospitalier Universitaire UCLouvain Namur
申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Maximilien Gourdin

Directeur Médical adjoint aux missions universitaires

Centre Hospitalier Universitaire UCLouvain Namur

研究点 (1)

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