AZ@GAME-Eco: Economic Assessment of Serious Games for the Management of Alzheimer's Disease and Related Disorders (AZ@GAME-Eco)
Primary Purpose
Alzheimer Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
serious games use
usual care
Sponsored by
About this trial
This is an interventional prevention trial for Alzheimer Disease
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- history of epilepsy
- major walking or balance disorder.
- Subject without freedom by judicial or administrative decision
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
serious games
usual care
Arm Description
Outcomes
Primary Outcome Measures
cost utility ratio
Measurement of the incremental cost-utility ratio of the management of patients suffering from Alzheimer's disease
Secondary Outcome Measures
Full Information
NCT ID
NCT03208491
First Posted
June 26, 2017
Last Updated
July 3, 2017
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT03208491
Brief Title
AZ@GAME-Eco: Economic Assessment of Serious Games for the Management of Alzheimer's Disease and Related Disorders
Acronym
AZ@GAME-Eco
Official Title
AZ@GAME-Eco: Economic Assessment of Serious Games for the Management of Alzheimer's Disease and Related Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 30, 2017 (Anticipated)
Primary Completion Date
March 30, 2018 (Anticipated)
Study Completion Date
December 30, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
serious games
Arm Type
Experimental
Arm Title
usual care
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
serious games use
Intervention Description
This program has enabled several SGs to be developed that allow physical and cognitive workouts to be carried out with a therapist
Intervention Type
Other
Intervention Name(s)
usual care
Intervention Description
usual care of patient
Primary Outcome Measure Information:
Title
cost utility ratio
Description
Measurement of the incremental cost-utility ratio of the management of patients suffering from Alzheimer's disease
Time Frame
at 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
history of epilepsy
major walking or balance disorder.
Subject without freedom by judicial or administrative decision
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vanina OLIVERI, PM
Phone
0033 4 92 03 42 54
Email
oliveri.v@chu-nice.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
AZ@GAME-Eco: Economic Assessment of Serious Games for the Management of Alzheimer's Disease and Related Disorders
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