Efficacy and Scalability of a Multi-domain Digital Health Intervention Via Smartphone Application and Wearable Data: A Randomized Controlled Trial in Healthy Elderly Population
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Cognitive Function
研究概览
简要总结
This study evaluates the efficacy of a smartphone-based multi-domain intervention designed to promote healthy aging and prevent cognitive decline in older adults. Building on preliminary findings that automated alerts improved exercise, sleep and nutrition-thereby mediating enhanced cognitive performance-we developed a dedicated application that integrates longitudinal Fitbit data (activity, sleep, and nutrition) with daily interactive dialogues powered by Generative AI (LLM).
A six-month Randomized Controlled Trial (RCT) will be conducted with 300 healthy participants aged 65 and older. The primary objective is to analyze how these digital interventions influence health outcomes, particularly cognitive and motor functions. Furthermore, we aim to construct a predictive mathematical model to estimate health states based on wearable data streams. Finally, the study will assess the potential for scalability to facilitate the large-scale social implementation of this digital health service.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 93 Years(Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to use a smartphone and wearable device (Fitbit).
排除标准
- •Physical conditions that prohibit regular exercise. Individuals diagnosed with dementia
研究组 & 干预措施
Multidomain Intervention
干预措施: Multidomain intervention (Combination Product)
Control
干预措施: Control (Other)
结局指标
主要结局
Cognitive Function
时间窗: Baseline and 6 months
MoCA
次要结局
- Cognitive function(Baseline and 6 months)
研究者
Tatsuhiro Hisatsune
Associate Professor
Tokyo University
