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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
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alzheimer Disease

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 26, 2017
    Last Updated
    July 3, 2017
    Sponsor
    Centre Hospitalier Universitaire de Nice
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    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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