MyHeart Counts: Stanford Mobile Cardiovascular Health Study 3.0 — MHC3  

Cardiovascular Health Clinical Trial

Official title: MyHeart Counts: Stanford Mobile Cardiovascular Health Study 3.0

Status Withdrawn

Clinical Trial Summary

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.

Clinical Trial Description

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.

The investigators will also perform a pilot study of up to 50 subjects to test the app prior to release to the general public. Given the potential for large numbers of the general public to download the app for the main study, it is essential that bugs and usage issues with the app be identified and fixed through this larger pilot study. As per the IRB (Institutional Review Board) guidelines, this pilot study will only be "exploratory" in order to help "refine data collection procedures and instruments or prepare a better, more precise research design." Data collected from this pilot study will not be used as research data nor stored permanently. The investigators plan to ask colleagues, including Stanford employees, to use the app for up to 3 months, with periodic contact by research staff for feedback on bugs and other usage issues.

The study is funded by Stanford Medicine, with staff, content and in-kind software development support for the app from Google Inc., including participation of Boston Technology Corporation (Marlborough, MA), an app development company that was hired to create MyStudies. ;

Related Conditions & MeSH terms

• Cardiovascular Health

• NCT number: NCT04183010
• Study type: Interventional
• Source: Stanford University
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2023
• Completion date: January 1, 2026