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临床试验/NCT04183010
NCT04183010撤回不适用

MyHeart Counts: Stanford Mobile Cardiovascular Health Study 3.0

Stanford University2 个研究点 分布在 1 个国家开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Change in daily step count

研究概览

简要总结

MyHeart Counts is a smartphone-based mobile cardiovascular health research study. It will use the mobile health capabilities of smartphones and wearables to assess daily activity measures of the general public and compare these to measures of cardiovascular health - risk factors and fitness. How people divide their time among exercise, sedentary behavior, and sleep all affect cardiovascular health, yet largely go unmeasured. These can now be measured with sensors in phones or wearable devices as we have shown on iOS. With the large number of smartphone users addressable with a HIPAA complaint iOS & Android platform, the investigators aim to collect activity and cardiovascular health data on many more subjects than in prior studies as well as provide much more quantitative data on type, duration, and intensity of daily activities. It also provides a platform to investigate methods to help participants increase heart-healthy activities. The study also includes a randomized controlled trial on physical activity. The overall goal is to develop an extensive source of data to help inform future cardiovascular health guidelines.

详细描述

The MyHeart Counts research study was designed by Stanford faculty. MyHeart Counts 3.0 will run using the MyStudies Platform, originally commissioned by the FDA, which is currently undergoing technical development to be able to run on the Google Cloud. It includes servers used to set up the study and collect study data, as well as features that produce both iOS and Android study applications using Apple ResearchKit and Android ReserachStack frameworks.

The subject will be consented through their smartphone. After downloading the app from the App Store, the user will be shown a series of screens that ask eligibility questions and explain the general nature of the study and require interaction and acknowledgment of the subject. These smartphone consent process screens have been adapted from MyHeart Counts, which based its design an open source toolkit developed by Sage Bionetworks in collaboration with the Electronic Data Methods forum of the AHRQ (Agency for Healthcare Research & Quality). The investigators have also reviewed this mobile consent process and screenshots with faculty in the Stanford Center for Biomedical Ethics. After reviewing the consent screens, the user will be shown the consent form and can scroll through and accept prior to enrollment. The user will have the option to email themselves the consent form.

After consent, subjects will be surveyed about their current cardiovascular health and risk factors and asked to share their activity data collected by the phone and/or any wearable activity device they have. They will then be asked to use their phone and/or wearable to monitor their daily activity for 1 week. They will then be asked to do a standard 6- minute walk test (with the phone/wearable measuring the distance covered), 3 minute step tests and 12 minute runs, with included activities that use the phone's camera to assess heart rate and heart rate recovery.

Every 3 months for at least one year, subjects will be asked to repeat the above to assess for changes - 1) update surveys/risk factors, 2) monitor activity for 1 week, and 3) aforementioned activity tests.

In addition to the health, activity, and fitness assessment, the investigators will give participants the option of joining a randomized controlled trial on physical activity. Participants opting to participate will be randomized to either receive personalized activity coaching including physical activity recommendations, endurance training sessions and video classes or no specific content. All participants will be prompted to conduct periodic cardiorespiratory testing via a task within their smartphone application.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

盲法说明

Participants will not be told if they are assigned to the control arm or the coaching arm of the study.

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

  • Daily access to smartphone (iPhone or Android)
  • Living in the US during the duration of the study
  • Ability to understand written English

排除标准

  • International participants
  • Children (under 18)

结局指标

主要结局

Change in daily step count

时间窗: Measured daily for a period of 12 weeks, including 1 week of baseline monitoring and during the 11 week duration of the randomized arms.

Change in daily steps from the iPhone computed via HealthKit and from Android via Google Fit

次要结局

  • Compliance(Measured once at the end of the study, covering the 11 week duration of coaching.)
  • Change in resting heart rate(Measured monthly during the 12 week duration of the study)
  • Change in recovery heart rate(Measured monthly during the 12 week duration of the study)
  • Change in daily self-reported happiness(Measured daily during the 12 week duration of the study.)

研究者

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

Euan Ashley

Associate Dean, School of Medicine, Professor of Medicine (cardiovascular), of Genetics, of Biomedical Data Science and, by courtesy, of Pathology at the Stanford University Medical Center

Stanford University

研究点 (2)

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