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临床试验/NCT07428122
NCT07428122尚未招募不适用

My Heart Counts Cardiovascular Health Study

Stanford University0 个研究点目标入组 15,000 人开始时间: 2026年4月30日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
15,000
主要终点
Change in Physical Activity levels

研究概览

简要总结

The My Heart Counts Cardiovascular Health Study will utilize mobile health capabilities of smartphones to assess daily activity measures and compare these to measures of cardiovascular health risk factors and fitness. The study aims to collect cardiovascular health data on a diverse population by making the application available on both iOS and Android platforms. Using smartphone sensors and connected devices, the study will collect physical activity metrics, heart rate data, and responses to health questionnaires. The study includes a randomized crossover trial component examining the effectiveness of personalized activity coaching prompts generated by a language model compared to generic prompts.

详细描述

My Heart Counts is a smartphone-based mobile cardiovascular health research study designed to collect data on physical activity and heart health across a broad population. This new version expands on the original study (IRB-31409) with several key improvements: inclusion of Android users alongside iOS, creation of a Spanish-language version, and, for future versions of the app, development of a platform architecture that can host multiple sub-studies.

The study will utilize smartphone sensors and connected devices to measure physical activity patterns, fitness levels through standardized tests (6-minute walk test, 12-minute run/walk test), and cardiovascular risk factors reported through health questionnaires. All data collection occurs remotely through participants' smartphones without requiring clinical visits.

A key component of the study is a 14-day randomized crossover trial evaluating the effectiveness of different physical activity coaching approaches.

Participants will experience both personalized coaching messages generated by a large language model and standard activity prompts, each for 7 days, in a randomly assigned order. The primary outcome will be the change in physical activity levels between intervention periods.

The study will serve as a digital biobank, with data made available to qualified researchers after appropriate de-identification. This platform approach will enable efficient recruitment for future cardiovascular health sub-studies without requiring development of new applications.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age or older
  • Resident of the United States
  • Able to read, understand and consent to study

排除标准

  • Not owning a compatible iOS or Android smartphone

研究组 & 干预措施

Generic Activity Prompts

Placebo Comparator

干预措施: Generic Activity Prompts (Behavioral)

Personalized LLM Coaching

Active Comparator

干预措施: Personalized LLM Coaching (Behavioral)

结局指标

主要结局

Change in Physical Activity levels

时间窗: Time Frame: 14 days (7 days in each intervention period)

Change in daily physical activity levels as measured by step count smartphone sensors and connected health devices.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Euan Ashley

Chair, Department of Medicine

Stanford University

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