e-VITA: European-Japanese Virtual Coach for Smart Ageing (WAVE II)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 240
- 试验地点
- 4
- 主要终点
- Change in the Quality of Life
研究概览
简要总结
The study is a multicentre Proof-of-Concept. The general objective of the e-VITA project is to develop a personalized virtual coach capable of interacting with its elderly interlocutor. The experimentation will be carried out in 4 sites: Italy, France, Germany and Japan.
详细描述
The general objective of the e-VITA project is to improve well-being for older adults and thereby promote active and healthy ageing, contribute to independent living, and reduce risks of social exclusion of older adults by making use a virtual coach by 240 healthy older adults recruited from Europe (France, Germany and Italy) and Japan. The study is a multicenter Proof-of-Concept study with a duration of the intervention of six months.
The multidisciplinary consortium collaborating in this project will develop an innovative ICT-based virtual coaching system to detect subtle changes in physical, cognitive, psychological and social domains of older adult's daily life. The e-VITA virtual coach will thus provide personalized recommendations and interventions, for sustainable wellbeing in a smart living environment at home.
The different components of the system are:
- Coaches, consisting of social robots, that will interact with the users and are guided by apps;
- Sensors (both wearable and domestic) to detect physiological parameters, physical activities, and behavior of the users; these sensors are: the Huawei smart band (wearable), the NeU device (wearable), and the DeltaDore system (domestic).
- Smartphones (the chatbot to provide insights, suggestion, and stimulation about healthy nutrition and physical exercise; the social platform to encourage users to share their interests).
These components (coaches, sensors, chatbot and social platform) together with a main software named Use Cases Configurator (UCC) constitute the Virtual Coach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to stand and walk unaided;
- •No acute or untreated medical problems;
- •Montreal Cognitive Assessement test (MOCA) ≥ 22;
- •Geriatric Depression Scale (GDS) < 9;
- •Short performance physical battery (SPPB) ≥ 7
- •Clinical Frailty Scale score between 2 and 4.
排除标准
- •Use of active implant or not-implant medical devices;
- •Allergy to nichel;
- •A myocardial infarction or stroke within 6 months;
- •Painful arthritis, spinal stenosis, amputation, painful foot lesions or neuropathy limiting balance and mobility;
- •Uncontrolled hypertension;
- •Pacemaker or implantable cardioverter defibrillator;
研究组 & 干预措施
Gatebox group
干预措施: Virtual coach with Gatebox device (Device)
CelesTE robot group
干预措施: virtual coach with CelesTE robot (Device)
Control group
干预措施: booklet (Other)
NAO robot group
干预措施: Virtual coach with NAO robot (Device)
Google Nest Hub (2e generation) group
干预措施: Virtual coach with Google Nest Hub (2e generation) group (Device)
结局指标
主要结局
Change in the Quality of Life
时间窗: baseline and 6 months later
The EQ-5D-5L scale consists of five dimensions: mobility, independence, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, mild problems, moderate problems, severe problems and extreme problems. The participant is asked to indicate his/her health status by ticking the box corresponding to the most appropriate statement in each of the five dimensions. The numbers from the five dimensions can be combined into a 5-digit number that describes the health status of the participant.
次要结局
- Change in frailty status(baseline and 6 months later)
- Change in nutritional capacity(baseline and 6 months later)
- Change in performance status(baseline and 6 months later)
- Change in usability(At 3 and 6 months from baseline)
- Change in psychological mood(baseline and 6 months later)
- Change in cognitive status(baseline and 6 months later)
- Change in affinity with technology(baseline and 6 months later)
- Change in person's need for technology(baseline and 6 months later)