New Virtual Reality Technologies and Telemedicine for Cognitive Rehabilitation in Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      Main objective: To verify the effectiveness of a cognitive rehabilitation program in
      Alzheimer patients, based on virtual reality, delivered remotely, at the patient's home, with
      two distinct methods: a tablet or an App (on the patient's smartphone).

      Total treatment duration: 2 months.

      Main endpoint: Post rehabilitation assessment of the patient's cognitive level; Secondary
      endpoints: assessment of patients' quality of life quality of life and patients' and
      caregivers' satisfaction.

      The neuropsychological assessment of the patients includes: Mini Mental State Examination
      (primary outcome), quality of life in Alzheimer's disease (QoL-AD), Geriatric Depression
      Scale (GDS). The following questionnaires will be submitted to caregivers: Beck Depression
      Inventory-II (BDI), System Usability Scale (SUS).
    

Detailed description: 
      Multicentric study involving the following 14 italian hospitals: San Raffaele Hospital of
      Milan, Fondazione Istituto Neurologico Carlo Besta, Istituto delle Scienze Neurologiche di
      Bologna, Fondazione Ca' Granda - Ospedale Maggiore Policlinico, Fondazione Don Carlo Gnocchi
      Onlus, Istituto Auxologico Italiano, Humanitas Mirasole, Istituti Clinici Scientifici
      Maugeri, Fondazione Istituto Neurologico Nazionale C. Mondino, Istituto Centro San Giovanni
      di Dio Fatebenefratelli, Fondazione Ospedale San Camillo, Fondazione Santa Lucia, Fondazione
      Policlinico Universitario Agostino Gemelli, Associazione Oasi Maria SS Onlus.

      40 patients affected by Alzheimer's disease, with initial to severe cognitive impairment
      (MMSE 13-24), and 1 of their caregivers (total caregivers: N=40) will be included in the
      study (total n= 80 subjects).

      The protocol provides for two treatment groups:

        -  Tablet group (total number = 20 patients): cognitive rehabilitation carried out in
           telemedicine at home with tablets (using Khymeia VRRS Home Tablet equipment).

        -  App group (total number = 20 patients): cognitive rehabilitation carried out in
           telemedicine at home with the App (Khymeia App Medico Amico).

      Each AD patient, regardless of the severity of the cognitive impairment in progress, will be
      assigned to a treatment group. Allocation to the treatment group will be randomized by
      stratified randomization by severity of cognitive impairment (initial and moderate level,
      having MMSE between 24 and 18, vs., medium-severe level, having MMSE between 17 and 13).

      Cognitive rehabilitation, for each group, will last two months. Patients will undergo 45
      minutes of telehealth cognitive rehabilitation per day, 5 days a week, for a total duration
      of 2 months.

      In both groups (Tablet or App), the rehabilitation exercises will be focused on the following
      cognitive functions:

        -  Language

        -  Attention

        -  Executive functions

        -  Verbal memory

        -  Visuo-spatial memory

      Evaluations will be carried out PRE and POST treatment, remotely (patient and caregiver at
      home, neuropsychologist in hospital).

      PRE Ratings:

        -  Within 7 days before the start of treatment;

        -  Patient assessments: Mini Mental State Examination (primary outcome), quality of life in
           Alzheimer's disease (QoL-AD), Geriatric Depression Scale (GDS);

        -  Caregiver assessments: Beck Depression Inventory-II (BDI).

      POST Ratings:

        -  Within 7 days after the last treatment session;

        -  Patient assessments: Mini Mental State Examination (primary outcome), quality of life in
           Alzheimer's disease (QoL-AD), Geriatric Depression Scale (GDS);

        -  Caregiver assessments: Beck Depression Inventory-II (BDI), System Usability Scale (SUS).

      Total study duration per participant: 2.5 months.
    

Intervention name(s): Cognitive rehabilitation using interactive tablet; Cognitive rehabilitation using smartphone App Medico Amico
Intervention type(s): Procedure; Procedure
Intervention description(s): the cognitive rehabilitation exercises will be administered using the Khymeia VRRS Home Tablet. Patients will be asked to actively carry out exercises focused on the following cognitive functions: language, attention, executive functions, verbal memory, visuo-spatial memory.; the cognitive rehabilitation exercises will be administered through patients' smartphone using the Medico Amico App. Patients will be asked to observe and concentrate on exercises focused on the following cognitive functions: language, attention, executive functions, verbal memory, visuo-spatial memory.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care