MyHeart Counts Cardiovascular Health Study

Cardiovascular Health Clinical Trial

— MHC  

Official title:

MyHeart Counts Cardiovascular Health Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03090321
• Other study ID #: 31409
• Status: Recruiting
• Phase: N/A
• Start date: March 2015
• Est. completion date: December 2025

Study information

• Verified date: April 2019
• Source: Stanford University
• Contact: Anna Shcherbina, MEng
• Phone: 310 689 6688
• Email: annashch[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The MyHeart Counts Cardiovascular Health Study will utilize mobile health capabilities of smartphones and wearables to assess daily activity measures of the general population 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 to date these have largely gone unmeasured. With the advancement of phone sensors and wearable fitness tracking devices these factors are now more straightforward to gather and measure. The use of smartphones by a large segment of the population allows for data collection on an unprecedented scale. The investigators aim to amass activity and cardiovascular health data on thousands of participants as well as provide significantly more quantitative data on type,duration, and intensity of daily activities.

In the second phase of the MyHeart Counts Cardiovascular Health Study (Randomized Assessment of Physical Activity Prompts In A Large Ambulatory Population) the researchers will conduct a randomized controlled clinical trial of four different physical activity prompts (intervention) and their effect on the level of physical activity in the study population as measured by change in step count.

Description:

MyHeart Counts Cardiovascular Health Study is a smartphone-based mobile cardiovascular health research study. The study will utilize 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 these largely go unmeasured. With the advancement in phone sensors and wearables these factors are now more straightforward to gather and measure. The use of smartphones by a large segment of the population allows for data collection on an unprecedented scale. The investigators aim to amass activity and cardiovascular health data on thousands of participants as well as provide much more quantitative data on type,duration, and intensity of daily activities. The MyHeart Counts Cardiovascular Health mobile application provides a platform for the investigation of methods aimed to aid participants in increasing heart healthy activities. The overall goal of the study is to develop an extensive source of data which will inform future cardiovascular health guidelines.

In the second phase of the MyHeart Counts Cardiovascular Health Study (Randomized Assessment of Physical Activity Prompts In A Large Ambulatory Population) the investigators will conduct a randomized controlled clinical trial of four different physical activity prompts (intervention) and their effect on increasing physical activity in the study population as measured by change in step count.

Of note to supplement the activity data the investigators will ask participants who have completed a genetic analysis to share their that data with the MyHeart Counts Cardiovascular Health Study research team. The investigators believe the opportunity to overlay activity, heart risk and genetic data for participants is a great tool for discovery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000000
• Est. completion date: December 2025
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All adults over the age of 18

Exclusion Criteria:

• Children under the age of 18

Related Conditions & MeSH terms

• Cardiovascular Health

Intervention

Behavioral:
• Stand Prompt
The participant will receive a notification asking them to stand or walk if they have been sitting for longer than 60 minutes
• Step Prompt
The participant will receive a notification if they are below 5000 steps by 3pm each day asking them to get to 10000 steps.
• Cluster Prompt
The participant will receive daily information notifications specific to the activity cluster they fall into based on the activity data collected in phase 1 of the study
• Read AHA website
Daily reminder to read the newsfeed from the American Heart Association (AHA) website, this is a control arm

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Knowles JW, Assimes TL, Kiernan M, Pavlovic A, Goldstein BA, Yank V, McConnell MV, Absher D, Bustamante C, Ashley EA, Ioannidis JP. Randomized trial of personal genomics for preventive cardiology: design and challenges. Circ Cardiovasc Genet. 2012 Jun;5(3):368-76. doi: 10.1161/CIRCGENETICS.112.962746. — View Citation

Organisation for Economic Co-operation and Development (OECD). OECD Guidelines on Measuring Subjective Well-being. Paris: OECD Publishing; 2013 Mar 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Activity frequency and duration as Measured By Smartphone Core Motion Chip Sensor (Step count as seen in Apple's Healthkit)	The researchers will compare step count data collected during baseline (or phase 1) week with step count data at the end of each of the 4 intervention weeks.	5 weeks
Secondary	Change in self reported levels of happiness as indicated on a numerical gradient scale and self reported by participant using the OECD Guidelines on Measuring Subjective Well Being survey		5 weeks
Secondary	Change in responses ( to survey questions on self perceived risk of cardiovascular disease and well being (survey adopted from reference in description)	Each answer prompt on the survey is given a unique numerical value which is then added and averaged. The researchers will investigate for changes in this score at baseline and during interventions.	5 weeks
Secondary	Change in sleep duration as measured by Apples core motion chip.	The iphone is able to track sleep by sensing lack of motion between self reported sleeping and wake times. The investigators will compare the average sleep time detected by phone at baseline and at the end of each intervention week.	5 weeks
Secondary	Change in self reported sleep duration obtained from a daily user survey.	The researchers will compare self reported sleep time at baseline vs end of each intervention week.	5 weeks