Alzheimer Disease Clinical Trial
Official title:
AZ@GAME-Eco: Economic Assessment of Serious Games for the Management of Alzheimer's Disease and Related Disorders
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.
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.
POPULATION Male or Female ≥ 60 years of age / with a diagnosis of Alzheimer's Disease or
related disorders (CIM10) condition with a Mini Mental State Examination score between 12 and
24. Patients are monitored in one of the centers participating in the study (Day Hospital,
nursing home, Memory Consultation).
METHOD This multi-center study involves 18 participating centers: Dependent Elderly Care
Facilities (EHPAD), Day Care Centers, and Memory Centers, with the inclusion of 144 subjects
(72 subjects per group and 8 subjects per center). It will be done in open form.
After randomization, the centers belonging to the intervention group use the SG for 3 months
(2 sessions per week). The control group centers will be able to use the SG at the end of the
study.
Medico-economic and clinical evaluations will be performed at baseline, at the end of the
intervention (M3) and 3 months after the intervention (M6). An incremental cost-utility ratio
will be calculated to compare the management with SG therapeutics and the usual management
from a societal perspective and with a time horizon of 6 months.
BENEFITS To gain a better understanding of the medico-economic benefits and usability of a
new technology to train cognitive, physical functions while promoting motivation and social
engagement in Alzheimer's disease patients in situations Usual care in Daycare, Nursing home
and Memory center.
PARTNERS Montpellier University Health Center / Groupe Genious / Alzheimer Innovation
Association / Institut national de recherche en informatique et en automatique (INRIA)
Sophia-Antipolis - STARS team
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