Cardiovascular HealthMHC3NCT04183010
MyHeart Counts: Stanford Mobile Cardiovascular Health Study 3.0
A study testing Physical activity coaching in people with Cardiovascular Health, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Health
- What is being tested?
- Physical activity coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18+
- Daily access to smartphone (iPhone or Android)
- Living in the US during the duration of the study
- Ability to understand written English
Who cannot join
- International participants
- Children (under 18)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Cardiovascular Health
- Being tested
- Physical activity coaching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity coachingBehavioural
Interventions will be delivered via smartphone and will consist of physical activity coaching. Once randomized to the Coaching arm, individuals will be presented with seven broad categories of physical activity. They will receive a daily notification on their phone indicating that they have study activities to complete. They will then click on this notification and will be offered five options:
- A low intensity activity from one of the categories they selected upon start of coaching
- A moderate-to-vigorous endurance activity
- The participant will be linked to video content with exercise tutorials/video coaching
- Option to skip exercise that day
- Option to fill in a different activity that the participant completed (free text entry)
The participant will then select one of these options and complete the chosen activity. They will be presented with the question "Did you completed the exercise" with three options:
- Yes
- No
- "Give me a different exercise"
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | At the end of this initial week of monitoring, participants will be randomized to a control group or an intervention group. Both groups will be followed for three months, with outcome measurements collected monthly. Both arms will continue to receive their seven day physical activity assessment using the phone's core motion sensors and HealthKit/ Google Health step count. Both groups will also be prompted to complete monthly fitness tests: the 6-minute walk test, a 12 minute run test, and the Tecumseh step test. |
| Physical activity coaching | Experimental | In addition to the tasks performed and feedback received by the Control arm (see above), the intervention arm will also undergo daily coaching with the goal of increasing their daily step count. Members of this arm will receive daily app notifications indicating that they have activities to complete. They will be provided with 5 exercise options:
* Low intensity activity options (i.e. walking in the part, bicycling to the store, etc.).
* Moderate to vigorous endurance activity, performed on their own (running, bicycling, rowing, swimming, etc)
* An on demand "group session" video
* No exercise today
* Alternate physical activity -- the participants will have the option to record alternate physical activity that they performed
Participants will be asked to indicate if they completed the exercise with three options:
* Yes
* No
* Request for a different exercise to be shown Receives: Behavioral: Physical activity coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in daily step count
Change in daily steps from the iPhone computed via HealthKit and from Android via Google Fit
Measured: Measured daily for a period of 12 weeks, including 1 week of baseline monitoring and during the 11 week duration of the randomized arms.
Secondary outcomes (4)
Compliance
Number of exercise sessions completed during the duration of the study.
Measured: Measured once at the end of the study, covering the 11 week duration of coaching.
Change in resting heart rate
Change in resting heart rate measured via phone PPG (photoelectric plethysmography) sensors.
Measured: Measured monthly during the 12 week duration of the study
Change in recovery heart rate
Change in recovery heart rate measured via phone PPG (photoelectric plethysmography
) sensors.
Measured: Measured monthly during the 12 week duration of the study
Change in daily self-reported happiness
Participants complete a daily questionnaire in which they are asked "How happy are you feeling today" on a scale of 0 (least happy) to 10 (most happy). Changes in their responses over time are measured.
Measured: Measured daily during the 12 week duration of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start1 Jan 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2026 (estimated)
Why it stopped: Lack of Funding to support the study application
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular HealthStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study participants will download the MyHeart Counts 3.0 app from their smartphone app store. They will undergo electronic consent, followed by a week of baseline monitoring, during which the phone will track their step count and acceleration. Participants will additionally complete questionnaires about their lifestyle and any risk factors for cardiovascular disease. At the end of this initial week of monitoring, participants will be randomized to a control group or an intervention group. Both groups will be followed for three months, with outcome measurements collected monthly. The intervention arm will also undergo daily coaching with the goal of increasing their daily step count. Members of this arm will receive daily app notifications indicating that they have activities to complete. They will be provided with 5 exercise options.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Google LLC.
- Responsible party
- Principal investigator, Euan Ashley, Stanford University
- Investigators
- Euan A Ashley, MRCP, DPhil, Principal investigator, Stanford UniversityAnders Johnson, Study director, Stanford UniversityAlex Tolas, Study director, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04183010
- Sponsor's protocol ID
- 54220
- Acronym
- MHC3
- Status last verified
- Feb 2024
- First submitted
- 22 Nov 2019
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon completion of the study, the anonymized participant data will be made available to qualified researchers for download through a portal on synapse.org.
Publications
Hershman SG, Bot BM, Shcherbina A, Doerr M, Moayedi Y, Pavlovic A, Waggott D, Cho MK, Rosenberger ME, Haskell WL, Myers J, Champagne MA, Mignot E, Salvi D, Landray M, Tarassenko L, Harrington RA, Yeung AC, McConnell MV, Ashley EA. Physical activity, sleep and cardiovascular health data for 50,000 individuals from the MyHeart Counts Study. Sci Data. 2019 Apr 11;6(1):24. doi: 10.1038/s41597-019-0016-7.
PubMed 30975992McConnell MV, Shcherbina A, Pavlovic A, Homburger JR, Goldfeder RL, Waggot D, Cho MK, Rosenberger ME, Haskell WL, Myers J, Champagne MA, Mignot E, Landray M, Tarassenko L, Harrington RA, Yeung AC, Ashley EA. Feasibility of Obtaining Measures of Lifestyle From a Smartphone App: The MyHeart Counts Cardiovascular Health Study. JAMA Cardiol. 2017 Jan 1;2(1):67-76. doi: 10.1001/jamacardio.2016.4395.
PubMed 27973671Shcherbina A, Hershman SG, Lazzeroni L, King AC, O'Sullivan JW, Hekler E, Moayedi Y, Pavlovic A, Waggott D, Sharma A, Yeung A, Christle JW, Wheeler MT, McConnell MV, Harrington RA, Ashley EA. The effect of digital physical activity interventions on daily step count: a randomised controlled crossover substudy of the MyHeart Counts Cardiovascular Health Study. Lancet Digit Health. 2019 Nov;1(7):e344-e352. doi: 10.1016/S2589-7500(19)30129-3. Epub 2019 Oct 9.
PubMed 33323209
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MyHeart Counts: Stanford Mobile Cardiovascular Health Study 3.0
- ClinicalTrials.gov ID
- NCT04183010
- Acronym / sponsor ID
- MHC3 / 54220
- Conditions
- Cardiovascular Health
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of Funding to support the study application
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Google LLC.
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 2 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Study participants will download the MyHeart Counts 3.0 app from their smartphone app store. They will undergo electronic consent, followed by a week of baseline monitoring, during which the phone will track their step count and acceleration. Participants will additionally complete questionnaires about their lifestyle and any risk factors for cardiovascular disease. At the end of this initial week of monitoring, participants will be randomized to a control group or an intervention group. Both groups will be followed for three months, with outcome measurements collected monthly. The intervention arm will also undergo daily coaching with the goal of increasing their daily step count. Members of this arm will receive daily app notifications indicating that they have activities to complete. They will be provided with 5 exercise options.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –At the end of this initial week of monitoring, participants will be randomized to a control group or an intervention group. Both groups will be followed for three months, with outcome measurements collected monthly. Both arms will continue to receive their seven day physical activity assessment using the phone's core motion sensors and HealthKit/ Google Health step count. Both groups will also be prompted to complete monthly fitness tests: the 6-minute walk test, a 12 minute run test, and the Tecumseh step test. |
| Physical activity coaching | Experimental | Behavioral: Physical activity coachingIn addition to the tasks performed and feedback received by the Control arm (see above), the intervention arm will also undergo daily coaching with the goal of increasing their daily step count. Members of this arm will receive daily app notifications indicating that they have activities to complete. They will be provided with 5 exercise options: * Low intensity activity options (i.e. walking in the part, bicycling to the store, etc.). * Moderate to vigorous endurance activity, performed on their own (running, bicycling, rowing, swimming, etc) * An on demand "group session" video * No exercise today * Alternate physical activity -- the participants will have the option to record alternate physical activity that they performed Participants will be asked to indicate if they completed the exercise with three options: * Yes * No * Request for a different exercise to be shown |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18+
- Daily access to smartphone (iPhone or Android)
- Living in the US during the duration of the study
- Ability to understand written English
Key exclusion criteria (2 listed)
- International participants
- Children (under 18)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity coachingInterventions will be delivered via smartphone and will consist of physical activity coaching. Once randomized to the Coaching arm, individuals will be presented with seven broad categories of physical activity. They will receive a daily notification on their phone indicating that they have study activities to complete. They will then click on this notification and will be offered five options: 1. A low intensity activity from one of the categories they selected upon start of coaching 2. A moderate-to-vigorous endurance activity 3. The participant will be linked to video content with exercise tutorials/video coaching 4. Option to skip exercise that day 5. Option to fill in a different activity that the participant completed (free text entry) The participant will then select one of these options and complete the chosen activity. They will be presented with the question "Did you completed the exercise" with three options: 1. Yes 2. No 3. "Give me a different exercise" | Behavioural | Physical activity coaching |
Primary outcome
Change in daily step count
Time frame: 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
4 secondary outcomes
Compliance
Time frame: Measured once at the end of the study, covering the 11 week duration of coaching.
Change in resting heart rate
Time frame: Measured monthly during the 12 week duration of the study
Change in recovery heart rate
Time frame: Measured monthly during the 12 week duration of the study
Change in daily self-reported happiness
Time frame: Measured daily during the 12 week duration of the study.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Results publication: PubMed 30975992Hershman SG, Bot BM, Shcherbina A, Doerr M, Moayedi Y, Pavlovic A, Waggott D, Cho MK, Rosenberger ME, Haskell WL, Myers J, Champagne MA, Mignot E, Salvi D, Landray M, Tarassenko L, Harrington RA, Yeung AC, McConnell MV, Ashley EA. Physical activity, sleep and cardiovascular health data for 50,000 individuals from the MyHeart Counts Study. Sci Data. 2019 Apr 11;6(1):24. doi: 10.1038/s41597-019-0016-7.
- Results publication: PubMed 27973671McConnell MV, Shcherbina A, Pavlovic A, Homburger JR, Goldfeder RL, Waggot D, Cho MK, Rosenberger ME, Haskell WL, Myers J, Champagne MA, Mignot E, Landray M, Tarassenko L, Harrington RA, Yeung AC, Ashley EA. Feasibility of Obtaining Measures of Lifestyle From a Smartphone App: The MyHeart Counts Cardiovascular Health Study. JAMA Cardiol. 2017 Jan 1;2(1):67-76. doi: 10.1001/jamacardio.2016.4395.
- Results publication: PubMed 33323209Shcherbina A, Hershman SG, Lazzeroni L, King AC, O'Sullivan JW, Hekler E, Moayedi Y, Pavlovic A, Waggott D, Sharma A, Yeung A, Christle JW, Wheeler MT, McConnell MV, Harrington RA, Ashley EA. The effect of digital physical activity interventions on daily step count: a randomised controlled crossover substudy of the MyHeart Counts Cardiovascular Health Study. Lancet Digit Health. 2019 Nov;1(7):e344-e352. doi: 10.1016/S2589-7500(19)30129-3. Epub 2019 Oct 9.
- App download link for MyHeart Counts appLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Upon completion of the study, the anonymized participant data will be made available to qualified researchers for download through a portal on synapse.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Euan A Ashley, MRCP, DPhil principal investigator
Stanford University
Anders Johnson study director
Stanford University
Alex Tolas study director
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity coaching in people with Cardiovascular Health, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in daily step count (time frame: Measured daily for a period of 12 weeks, including 1 week of baseline monitoring and during the 11 week duration of the randomized arms.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04183010, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.