Home-based Virtual Reality Cognitive Training as an add-on to Telerehabilitation in Alzheimer's Disease: Validation of a Protocol to Slow Down Cognitive Decline and Reduce Caregivers' Burden
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 48
- 主要终点
- Montreal Cognitive Assessment (MoCA)
研究概览
简要总结
Telemedicine has developed rapidly during the COVID-19 pandemic and is now integrated into the clinical practice of many hospitals. Telemedicine offers many advantages, and even after the end of the pandemic, many patients still choose to undergo healthcare visits remotely. However, the rapid expansion of telemedicine may be associated with the risk of providing patients with unvalidated and uncontrolled telehealth solutions, potentially negatively impacting their health.
In this study, the researchers aim to investigate the effectiveness of remote cognitive training in patients with mild-to-moderate Alzheimer's disease (AD) using tablets equipped with virtual reality-based cognitive exercises. The investigators also aim to evaluate the impact of online supervision of cognitive training by a neuropsychologist and to compare the costs and burden of home-based versus hospital-based cognitive training in patients with AD. This project will define the optimal modalities for cognitive telerehabilitation to ensure validated protocols for the continuity of care in AD.
详细描述
This project aims to use new technologies and telemedicine to ensure continuity of care and slow cognitive decline in patients with Alzheimer's disease (AD). The investigators also aim to reduce caregiver burden and healthcare costs for the national healthcare system.
The investigators hypothesize that patients provided with a VRRS tablet and undergoing autonomous cognitive training as an adjunct to cognitive telerehabilitation will achieve better cognitive outcomes than patients who do not receive a VRRS tablet.
The investigators also hypothesize that patients receiving both forms of cognitive training-autonomous training using the VRRS tablet combined with online cognitive telerehabilitation supervised by a professional neuropsychologist-will show greater improvements in cognitive function than patients who do not receive online cognitive telerehabilitation.
This is a prospective, interventional, randomized, single-blind, monocentric clinical study.
Study population: 48 patients with AD (MMSE score 18-24) and one caregiver for each patient (48 caregivers in total).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for patients with Alzheimer's disease (AD):
- •Age between 50 and 90 years.
- •Diagnosis of Alzheimer's disease according to established diagnostic criteria.
- •Mini-Mental State Examination (MMSE) score between 18 and
- •Stable pharmacological treatment for at least 3 months before enrolment.
- •Ability and willingness to provide written informed consent.
- •Inclusion criteria for caregivers:
- •Age ≥18 years.
- •Availability to assist the patient throughout the study.
- •Ability and willingness to provide written informed consent.
排除标准
- •for patients with Alzheimer's disease (AD):
- •Refusal or inability to provide written informed consent.
- •History of psychiatric disorders.
- •Significant cerebrovascular disease.
- •Severe visual or hearing impairment that could interfere with study procedures.
- •Psychosis.
- •Major depressive disorder.
- •Alcohol or substance abuse.
- •Use of psychotropic medications that may interfere with neuropsychological assessment or study treatment.
- •Concurrent participation in another interventional pharmacological clinical trial.
- •Any contraindication to undergoing EEG recording.
- •Exclusion criteria for caregivers:
- •Refusal or inability to provide written informed consent.
- •History of psychiatric disorders.
- •Major depressive disorder.
- •Alcohol or substance abuse.
- •Use of psychotropic medications that may interfere with neuropsychological assessment.
结局指标
主要结局
Montreal Cognitive Assessment (MoCA)
时间窗: (1) before telerehabilitation, (2) after the 3 month-rehabilitation period and (3) at 3 months follow-up after the end of treatment.
MoCA is a screening instrument to detect cognitive impairment. It generates a total score and six domain-specific index scores: (1) Memory, (2) Executive Functioning, (3) Attention, (4) Language, (5) Visuospatial, and (6) Orientation. The total possible score is 30 points; a score of 26 or above is considered normal, while scores below 26 may indicate cognitive impairment. Increase in MoCA scores meaning improvement in cognitive functioning.
Montreal Cognitive Assessment (MoCA)
时间窗: (1) before telerehabilitation, (2) at the end of the 3-month rehabilitation period, and (3) 3 months following the end of treatment.
MoCA is a screening instrument to detect cognitive impairment. It generates a total score and six domain-specific index scores: (1) Memory, (2) Executive Functioning, (3) Attention, (4) Language, (5) Visuospatial, and (6) Orientation. The total possible score is 30 points; a score of 26 or above is considered normal, while scores below 26 may indicate cognitive impairment. Increase in MoCA scores meaning improvement in cognitive functioning.
次要结局
- Electroencephalographic (EEG) activity((1) before telerehabilitation, (2) after the 3 month-rehabilitation period and (3) at 3 months follow-up after the end of treatment.)
- Caregivers' mental status((1) before telerehabilitation, (2) after the 3 month-rehabilitation period and (3) at 3 months follow-up after the end of treatment.)
- Caregivers' burden((1) before telerehabilitation, (2) after the 3 month-rehabilitation period and (3) at 3 months follow-up after the end of treatment.)
- System usability(At the post 3 month-treatment visit)
- Telerehabilitation's costs(At 3 months follow-up.)
- Mini Mental State Examination (MMSE)((1) before telerehabilitation, (2) after the 3 month-rehabilitation period and (3) at 3 months follow-up.)
- Quality of Live in Alzheimer's Disease (QoL-AD)((1) before telerehabilitation, (2) after the 3 month-rehabilitation period and (3) at 3 months follow-up)
- Geriatric Depression Scale (GDS)((1) before telerehabilitation, (2) after the 3 month-rehabilitation period and (3) at 3 months follow-up.)
- Attention matrices((1) before telerehabilitation, (2) after the 3 month-rehabilitation period and (3) at 3 months follow-up)
- Raven's Progressive Matrices (RPM)((1) before telerehabilitation, (2) after the 3 month-rehabilitation period and (3) at 3 months follow-up.)
- Token test((1) before telerehabilitation, (2) after the 3 month-rehabilitation period and (3) at 3 months follow-up.)
- Semantic and phonemic fluency((1) before telerehabilitation, (2) after the 3 month-rehabilitation period and (3) at 3 months follow-up.)
- Naming((1) before telerehabilitation, (2) after the 3 month-rehabilitation period and (3) at 3 months follow-up.)
- Word-picture naming test((1) before telerehabilitation, (2) after the 3 month-rehabilitation period and (3) at 3 months follow-up.)
- Digit Span test((1) before telerehabilitation, (2) after the 3 month-rehabilitation period and (3) at 3 months follow-up.)
- Hospital-based cognitive training costs(At 3 months follow-up.)
- Electroencephalographic (EEG) activity((1) before telerehabilitation, (2) at the end of the 3-month rehabilitation period, and (3) 3 months following the end of treatment.)
- Caregivers' mental status((1) before telerehabilitation, (2) at the end of the 3-month rehabilitation period, and (3) 3 months following the end of treatment.)
- Caregivers' burden((1) before telerehabilitation, (2) at the end of the 3-month rehabilitation period, and (3) 3 months following the end of treatment.)
- System usability(At the end of the 3-month rehabilitation period.)
- Mini Mental State Examination (MMSE)((1) before telerehabilitation, (2) at the end of the 3-month rehabilitation period, and (3) 3 months following the end of treatment.)
- Quality of Live in Alzheimer's Disease (QoL-AD)((1) before telerehabilitation, (2) at the end of the 3-month rehabilitation period, and (3) 3 months following the end of treatment.)
- Geriatric Depression Scale (GDS)((1) before telerehabilitation, (2) at the end of the 3-month rehabilitation period, and (3) 3 months following the end of treatment.)
- Attention matrices((1) before telerehabilitation, (2) at the end of the 3-month rehabilitation period, and (3) 3 months following the end of treatment.)
- Raven's Progressive Matrices (RPM)((1) before telerehabilitation, (2) at the end of the 3-month rehabilitation period, and (3) 3 months following the end of treatment.)
- Token test((1) before telerehabilitation, (2) at the end of the 3-month rehabilitation period, and (3) 3 months following the end of treatment.)
- Semantic and phonemic fluency((1) before telerehabilitation, (2) at the end of the 3-month rehabilitation period, and (3) 3 months following the end of treatment.)
- Naming((1) before telerehabilitation, (2) at the end of the 3-month rehabilitation period, and (3) 3 months following the end of treatment.)
- Word-picture naming test((1) before telerehabilitation, (2) at the end of the 3-month rehabilitation period, and (3) 3 months following the end of treatment.)
- Digit Span test((1) before telerehabilitation, (2) at the end of the 3-month rehabilitation period, and (3) 3 months following the end of treatment.)
研究者
Sandro Iannaccone
Director of Neurorehabilitation and Functional Recovery Department
IRCCS San Raffaele