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临床试验/NCT00479843
NCT00479843已完成不适用

Development of a Programme to Show the Positive Effect of a Nutritional Programme on Preventing Functional and Weight Losses in Patients With Dementia

Société des Produits Nestlé (SPN)2 个研究点 分布在 1 个国家目标入组 946 人开始时间: 2005年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
946
试验地点
2
主要终点
Evaluation of the effectiveness of the intervention -The main evaluation criteria which will allow the effectiveness of this intervention to be evaluated are the reduction in the loss of autonomy measured by the DA/IDA scale.

研究概览

简要总结

The main objective of this study is the improvement of the quality of life and state of health of elderly people with cognitive deterioration and their families through a weight loss prevention programme.

The secondary objectives are the improvement of the state of nutrition, a reduction in the use of resources and a reduction in the burden on the main carer.

详细描述

Main objective The main objective of this project is the evaluation of the effectiveness of a nutrition programme in patients with Alzheimer's or other dementias. Through the Nutrition Programme the idea is to reduce functional and weight loss in elderly people with cognitive deterioration and their families.

Evaluation of the effectiveness of the intervention

-The main evaluation criteria which will allow the effectiveness of this intervention to be evaluated are the reduction in the loss of autonomy measured by the DA/IDA scale.

Secondary objectives

The secondary objectives of this study are:

研究设计

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

入排标准

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

入选标准

  • The patient has dementia according to DSM IV criteria.
  • The patient has an MMSE less than or equal to
  • The patient lives in his/her home.
  • The patient is in the charge of a carer.
  • Informed consent for participation in the study by the responsible relative and, if possible, from the patient or legal guardian.

排除标准

  • The patient lives in an institution.
  • The patient is in a terminal situation.
  • The patient does not have a main carer.
  • Patient has a nasogastric feed.

结局指标

主要结局

Evaluation of the effectiveness of the intervention -The main evaluation criteria which will allow the effectiveness of this intervention to be evaluated are the reduction in the loss of autonomy measured by the DA/IDA scale.

时间窗: Baseline, 6 months, 12 months

次要结局

  • -Improvement in the patient's state of nutrition -Reducing the burden on carers with the Zarit scale. -Evaluation of the use of healthcare and social resources with the RUD scale. -Improvement of medical practice regarding nutrition.(Baseline, 6 months, 12 months)

研究者

发起方
Société des Produits Nestlé (SPN)
申办方类型
Industry

研究点 (2)

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