New Virtual Reality Technologies and Telemedicine for Cognitive Rehabilitation in Alzheimer's Disease
NCT ID: NCT05697354
Last Updated: 2023-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2021-08-30
2021-12-21
Brief Summary
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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).
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Tablet group
The Tablet group will carry out the exercises using the Khymeia VRRS Home Tablet.
Cognitive rehabilitation using interactive tablet
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.
App group
The App group will perform the exercises on their smartphone using the Khymeia Medico Amico App.
Cognitive rehabilitation using smartphone App Medico Amico
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.
Interventions
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Cognitive rehabilitation using interactive tablet
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.
Cognitive rehabilitation using smartphone App Medico Amico
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.
Eligibility Criteria
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Inclusion Criteria
* Proven diagnosis of Alzheimer's disease;
* MMSE score between 13 and 24;
* Aged between 50 and 80 years;
* Stable drug therapy for at least 3 months.
Exclusion Criteria
* Psychiatric diseases;
* Relevant cerebrovascular damage;
* Disabling visual or hearing impairments;
* Psychosis;
* Major depression;
* Abuse of alcohol or drugs;
* Use of psychopharmacological agents that may interfere with test performance or treatment.
* Participation in study protocols with experimental drugs.
50 Years
80 Years
ALL
Yes
Sponsors
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Ospedale San Raffaele
OTHER
Responsible Party
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Federica Alemanno
Psy.D., Ph.D., Responsible of the Neuropsychology Service, IRCCS San Raffaele Scientific Institute
Principal Investigators
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Federica Alemanno, Psy.D, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Ospedale San Raffaele
Locations
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Ospedale San Raffaele
Milan, , Italy
Countries
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Other Identifiers
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TaskCog-IVN
Identifier Type: -
Identifier Source: org_study_id
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