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临床试验/NCT07524478
NCT07524478招募中不适用

Efficacy and Scalability of a Multi-domain Digital Health Intervention Via Smartphone Application and Wearable Data: A Randomized Controlled Trial in Healthy Elderly Population

Tatsuhiro Hisatsune1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2026年3月10日最近更新:
适应症
干预措施

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

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

Experimental

干预措施: Multidomain intervention (Combination Product)

Control

Other

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

发起方
Tatsuhiro Hisatsune
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Tatsuhiro Hisatsune

Associate Professor

Tokyo University

研究点 (1)

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