Evaluation of the Impact of Care Based on Sensory Support for Elderly Patients Suffering From Alzheimer'S-type Neurodegenerative Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Change from baseline in NPI-Q scores
研究概览
简要总结
The main objective of this study is to evaluate the effect of 3 months of "Snoezelen-type" multi-sensory care sessions on NeuroPsychiatric Inventory Questionnaire (NPI-Q) scores for patients with Alzheimer's-type neurodegenerative disease.
详细描述
The secondary objectives of this study are to study the following elements in relationship to the implementation of a "Snoezelen-type" multi-sensory care strategy for patients with Alzheimer's-type neurodegenerative disease:
A. to evaluate the effects on NPI-Q scores at 1 month, 6 months and 12 months .
B. evaluate the effects on quality of life (questionnaire QOL-AD) at 0 and 12 months.
C. assess changes in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire over 0, 1, 3, 6 and 12 months.
D. assess changes in drug consumption (anxiolytics, antidepressants, hypnotics, neuroleptics)over the study period
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •The patient's legal representative must have given his/her informed and signed consent (or the patient if he/she is judged competent)
- •The patient must be insured or beneficiary of a health insurance plan
- •Alzheimer's-type neurodegenerative pathology
- •The patient has been living in the participating center for > 2 months
排除标准
- •The patient's legal representative refuses to sign the consent (or the patient if he/she is judged competent)
- •It is impossible to correctly inform the patient's legal representative
- •The patient has already has Snoezelen-therapy
研究组 & 干预措施
Study population
Patients hospitalized at the Serre-Cavalier centre and who have Alzheimer's-type neurodegenerative disease (see inclusion criteria).
干预措施: Multi-sensory supportive care (Other)
结局指标
主要结局
Change from baseline in NPI-Q scores
时间窗: 3 months
次要结局
- Change from baseline in NPI-Q scores(12 months)
- Change in drug consumption from baseline(12 months)
- Change from baseline in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire(12 months)
- Change from baseline in the Quality-of-life-Alzheimer's Disease questionnaire (QOL-AD)(12 months)
- Change from baseline in NPI-Q scores(1 month)
- Change from baseline in NPI-Q scores(6 months)
- Change from baseline in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire(1 month)
- Change from baseline in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire(3 months)
- Change from baseline in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire(6 months)
- Change in drug consumption from baseline(1 month)
- Change in drug consumption from baseline(3 months)
- Change in drug consumption from baseline(6 months)