Harmonization and Application of Cognitive Rehabilitation Protocols Using New Technologies of Virtual Reality and Telemedicine, in Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change from Mini Mental State Examination after treatment
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •inform consent
- •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.
排除标准
- •Denial of informed consent;
- •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.
结局指标
主要结局
Change from Mini Mental State Examination after treatment
时间窗: After 2 months of treatment
Neuropsychological test for the evaluation of cognitive efficiency and the presence of cognitive impairment. The test consists of thirty items, which refer to seven different cognitive areas: orientation in time, orientation in space, memory, attention, and calculation, language, constructive ability. It ranges from 0 (poorest score) to 30 (normal cognition). An increase of the MMSE score indicate an improvement in general cognition.
次要结局
- Change in Quality of life in Alzheimer's disease after treatment(After 2 months of treatment)
- Change in Geriatric Depression Scale after treatment(After 2 months of treatment)
- Change in Beck Depression Inventory-II after treatment(After 2 months of treatment)
- System Usability Scale after treatment(After 2 months of treatment)
研究者
Federica Alemanno
Psy.D., Ph.D., Responsible of the Neuropsychology Service, IRCCS San Raffaele Scientific Institute
Ospedale San Raffaele