September 30, 2021
University of Michigan PROviding Mental Health Precision Treatment (PROMPT) digital clinical research study
Clinical Trials & Research
April 5, 2022
The 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.
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
Year old median & mean age of participants
Participants were enrolled from the Third Generation Cohort, multiethnic Omni Group 2 Cohort, and New Offspring Spouse Cohort. Measurements tools included:
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.
Observations from the study included: