跳至主要内容
临床试验/NCT03208491
NCT03208491Unknown不适用

AZ@GAME-Eco: Economic Assessment of Serious Games for the Management of Alzheimer's Disease and Related Disorders

Centre Hospitalier Universitaire de Nice0 个研究点目标入组 136 人开始时间: 2017年9月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
136
主要终点
cost utility ratio

研究概览

简要总结

The main objective of AZ@GAME ECO is to evaluate the cost-utility of the management of patients suffering from Alzheimer's disease using a serious game providing cognitive and physical straining compared to a usual management. Among the secondary objectives it is important to assess the real life feasibility in different types of care structures.

详细描述

With the aging of the population, Alzheimer's disease and associated disorders represent a major public health challenge. To date there is no pharmacological treatment to stop the degenerative process or behavioral disorders. This explains the importance of non-pharmacological approaches to stimulate cognition, reduce behavioral disorders or improve quality of life. Non-pharmacological therapies are the central focus of care, especially for patients accommodated on a part-time basis (Day Hospital, Respite Platform) or Full-Time nursing home (EHPAD in French). TNM also holds an important place for patients living at home, and belongs to the very general framework of informal care, which is a significant cost.

In France, the cost of taking care of patients over 75 with this type of pathology is estimated between 24.2 and 30 billion euros per year, which is more than cancer or cardiovascular disease.

At the same time, new information and communication technologies (ICTs) play an increasingly important part in our daily lives and can be a support in the field of health. In this context, ICTs are of great interest for evaluation, rehabilitation and assistance. At the level of care, the aim is to propose applications to train and / or stimulate cognitions, behavior and motivation. Serious Games (SG) are part of this framework.

Az @ GAME (Alzheimer's Disease and serious games), is the winner of the e-health project 2011-2015. This program has enabled several SGs to be developed that allow physical and cognitive workouts to be carried out with a therapist. The AZ @ GAME-ECO + study is a new and innovative step as it represents the first combined evaluation of the cost and usefulness of managing patients with Alzheimer's disease using the serious Games (SG). In AZ @ GAME-ECO + SGs are a new tool for institutions involved in patient care.

OBJECTIVES The main objective of AZ@GAME ECO is to evaluate the cost-utility of the management of patients suffering from Alzheimer's disease using a serious game providing cognitive and physical straining compared to a usual management. Among the secondary objectives it is important to assess the real life feasibility in different types of care structures.

研究设计

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

入排标准

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

入选标准

  • •Male or Female ≥ 60 years of age;
  • •Subjects diagnosed with Alzheimer's Disease or related disorders associated with mild to moderately severe (CIM 10)
  • •a score between 12 and 24 on the Mini Mental score evaluation
  • •Subject treated in one of the participating centers
  • •To have the social welfare insurance
  • •Signature of the free and informed consent in the case of a patient under guardianship with signature of the guardian

排除标准

  • •history of epilepsy
  • •major walking or balance disorder.
  • •Subject without freedom by judicial or administrative decision

研究组 & 干预措施

serious games

Experimental

干预措施: serious games use (Other)

usual care

Active Comparator

干预措施: usual care (Other)

结局指标

主要结局

cost utility ratio

时间窗: at 3 months

Measurement of the incremental cost-utility ratio of the management of patients suffering from Alzheimer's disease

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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