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临床试验/NCT04094779
NCT04094779Unknown不适用

Effect of "Breath of Fresh Air" Flash Activity on Dementia Agitation : Pilot Study

University Hospital, Toulouse2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年9月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
2
主要终点
Comparison of the NeuroPsychiatric Inventory Reduced (NPI-reduced) score

研究概览

简要总结

Non-drug therapies (NDT) constitute a strong axis of the person with dementia behaviour management. Among these NDT, the flash activities constitute a mode of intervention to prevent and control the expression of the most disruptive behavior. These are short-term activities with the objective of decreasing the behavioural disorders intensity in less than 15 minutes.

The aim of this pilot study is to test the effect of a flash activity "breath of fresh air" compared to the usual relational care on the short-term decrease (15 min.) of the agitation in hospitalized dementia patients.

详细描述

The "breath of fresh air" flash strategy is to offer the patient the possibility to go out of the medical unity and walking outdoor.

When the caregiver identify a level of agitation greater or equal to two on the gravity score and greater or equal to two on the impact score with the NPI test (The Neuropsychiatric Inventory Test), the caregiver let the patient wandering in the outside lanes of the hospital and encourage him to us his senses. For example, the sight could be stimulated by looking at a bird.

This variation of sensory stimulations enable a temporo-sensory break on the crisis, allowing the patient to turn his attention from the crisis context to another stimulation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • New patients admitted in the unit to the management of the Psychological and Behavioural Symptoms of Dementia
  • Dementia regardless of etiology and severity
  • Score greater than 2 than NPI established on entry into service
  • Free, informed and written consent signed by the person trust and/or family member and/or legal representative
  • Health insurance membership

排除标准

  • Absence of agitation
  • Juveniles
  • Pregnant women
  • Patient who has previously participated in the study
  • Persons under protection of justice

结局指标

主要结局

Comparison of the NeuroPsychiatric Inventory Reduced (NPI-reduced) score

时间窗: 15 minutes

Evolution of the score NPI-reduced agitation 15 minutes after installation of the strategy compared to the score assessed in the crisis. NPI reduced is about Gravity of the crisis from1 to 3 (1 better / 3 worse) and Impact of the crisis from 0 to 5 (0 better / 5 worse)

次要结局

  • Comparison of the NPI-reduced score(1 hours)
  • The NPI-CT (NeuroPsychiatric Inventory Care Team version) score(21 days)
  • Number of therapeutic strategies used(18 days)
  • The Cohen-Mansfield Agitation Inventory (CMAI) score(18 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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