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MyHeart Counts Cardiovascular Health Study (MHC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03090321
Recruitment Status : Recruiting
First Posted : March 24, 2017
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Euan Ashley, Stanford University

Brief 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.


Condition or disease Intervention/treatment Phase
Cardiovascular Health Behavioral: Stand Prompt Behavioral: Step Prompt Behavioral: Cluster Prompt Behavioral: Read AHA website Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: MyHeart Counts Cardiovascular Health Study
Study Start Date : March 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2025

Arm Intervention/treatment
Active Comparator: Stand Prompt
Behavioral Intervention Prompt- Participant will receive a notification asking them to stand and walk if they have been sitting for longer than 60 minutes.
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
Other Name: Behavior Change and Motivational Coaching-Stand Prompt

Active Comparator: 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.
Behavioral: 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.
Other Name: Behavior Change and Motivational Coaching- Step Prompt

Active Comparator: 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.
Behavioral: 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
Other Name: Behavior Change and Motivational Coaching- Cluster Prompt

Placebo Comparator: Read AHA website
Daily reminder to read the American Heart Association (AHA) website.
Behavioral: Read AHA website
Daily reminder to read the newsfeed from the American Heart Association (AHA) website, this is a control arm
Other Name: Behaviour Change and Motivational Coaching- Reminder to read the American Heart Association (AHA) website

No Intervention: Baseline monitoring
No feedback is provided to the users. This is the control arm.



Primary Outcome Measures :
  1. Activity frequency and duration as Measured By Smartphone Core Motion Chip Sensor (Step count as seen in Apple's Healthkit) [ Time Frame: 5 weeks ]
    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.


Secondary Outcome Measures :
  1. 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 [ Time Frame: 5 weeks ]
  2. Change in responses ( to survey questions on self perceived risk of cardiovascular disease and well being (survey adopted from reference in description) [ Time Frame: 5 weeks ]
    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.

  3. Change in sleep duration as measured by Apples core motion chip. [ Time Frame: 5 weeks ]
    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.

  4. Change in self reported sleep duration obtained from a daily user survey. [ Time Frame: 5 weeks ]
    The researchers will compare self reported sleep time at baseline vs end of each intervention week.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All adults over the age of 18

Exclusion Criteria:

  • Children under the age of 18

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090321


Contacts
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Contact: Anna Shcherbina, MEng 310 689 6688 annashch@stanford.edu
Contact: Euan Ashley, MD (650) 725-1846 euan@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Anna Shcherbina, MEng    310-689-6688    annashch@stanford.edu   
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Euan Ashley, MD Stanford University

Publications:
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Responsible Party: Euan Ashley, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03090321    
Other Study ID Numbers: 31409
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual user data will not be shared, deidentified user data will be shared if the user has indicated that this is ok with them.
Keywords provided by Euan Ashley, Stanford University:
fitness
health
activity
heart risk
wellness