My Heart Counts Cardiovascular Health Study
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
- 是
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
干预措施: Generic Activity Prompts (Behavioral)
Personalized LLM Coaching
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
Euan Ashley
Chair, Department of Medicine
Stanford University
