Case Study

Clinical Trials & Research
April 5, 2022

Framingham Heart Study Logo

The Electronic Framingham Heart Study (eFHS) Was Designed To Leverage Commercial Wearables and Digital Medical Devices

efhs screenThe electronic Framingham Heart Study (eFHS) was designed to leverage commercial wearables and digital medical devices, adding new mobile and digital phenotypes around heart rate, blood pressure, activity levels and sleep hygiene into the robust Framingham Heart Study (FHS). This was to compare new digital measures against the other gold standard CVD phenotypes already obtained in the FHS Research Center. 

To evaluate the scalability and reliability of digital and mobile health research, David McManus, JoAnne Murbito, Emelia Benjamin and the Framingham Heart Study (FHS) team leveraged the MyDataHelps™ designer to build a remote study in which they were able to quickly enroll and complete eConsent for 2,139 participants from existing FHS cohorts. The participants downloaded MyDataHelps™ and had high rates of completion for the baseline survey (89% completed all baseline surveys) and the 3-month survey (58%) with little reinforcement needed. Compared to similar e-cohorts, the eFHS survey completion rates were higher than prior studies, including the eCARDIA (52%) and the Health eHeart 37% studies.

Through the MyDataHelps™ app, the FHS team was also able to gather weekly blood pressure (BP) measurements via a bluetooth BP cuff and daily heart rate (HR) measurements via Apple Watches, which synced to the app.
 

eFHS screenshots

By integrating digital and mobile health into a traditional longitudinal study, we’re able to generate a richer understanding of the everyday predictors for cardiovascular health.

David McManus, MD
Cardiovascular Diseases, UMass Memorial Health

By the Numbers

Participant icon

2,139

Participants

Survey Clipboard icon

33,774

Surveys Delivered

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58

Year Old Median & Mean Age of Participants

Cumulative Enrollment by Day Chart

Participants were enrolled from the Third Generation Cohort, multiethnic Omni Group 2 Cohort, and New Offspring Spouse Cohort. Measurements tools included:

  • Nokia-Withings digital BP cuff model BP-801 to monitor daily BP levels
  • Apple Watch to monitor HR, activity levels and sleep pulled from the Apple health app
  • Surveys delivered through the MyDataHelps app (baseline surveys and then abbreviated surveys at 3, 6, 9, and 12 months after enrollment)

MyDataHelps™

The MyDataHelps app was used to message participants, administer surveys to collect health history and behavior updates, and pull data from wearables, including a digital BP cuff and smartwatch.

After participants downloaded MyDataHelps™, they were prompted to complete surveys that included digital versions of standardized assessments requesting information regarding: demographics, physical activity, mood, alcohol consumption, smoking, medications, CVD risk factors and other health conditions.

All participants received a welcome message, survey due-date reminders, notification of new activities, and reminder messages to comply with study protocols, including weekly home BP measurements and daily smartwatch use.


Results

Observations from the study included:

  • Despite minimal training & support, uptake and adherence to periodic app-based surveys over 12 months was high
  • An inverse association of higher, frequent physical activity with lower home BP measurements—even after adjusting for age, sex, watch wear time, antihypertensive drug use, and family structure.
  • Home BP is a stronger predictor of adverse cardiovascular outcomes compared with in-office BP
  • Self-monitoring of post exercise hypotension can improve exercise adherence