Cardiovascular Diseases
Conditions
Keywords
mHealth, digital BP monitoring, patient provider communication, smart watch, user engagement, population health data
Brief summary
In this research the investigators will develop and test an innovative scalable mobile health and digital cardiovascular monitoring system within a longitudinal deeply characterized cohort with three components: 1) smartphone application (app) designed to promote adherence, integrate digital and mHealth information, and facilitate communication with participants and researchers; 2) smartwatch activity monitoring using the Apple iWatch; and 3) home blood pressure (BP) monitoring using the Withings blood pressure device. The objective of the messaging trial is to test the effect of messaging strategies on improving participants' long-term use of and engagement with our selected mobile health technologies and on increasing response rate of survey data collection.
Detailed description
The research design includes a cohort eFHS Study and an embedded randomized factorial trial on a subset of the cohort. For the primary e-cohort, the investigators will build a custom mobile app for use within the Framingham Heart Study (FHS) to digitally collect data, compare it against research clinic-collected data, quantify risk factor burden, and perform CVD risk prediction. The app development will focus on 1) CVD risk factor data that would benefit from more frequent ascertainment than the every four to eight year FHS examination cycles; 2) circumstances where in vivo assessment may be superior to clinic-based assessment; 3) key endpoints of the FHS that are considered FHS landmarks. In addition to the eFHS App, participants will be offered wireless devices (Withings BP) to measure blood pressure and an Apple Watch to measure heart rate and steps per day. For the messaging trial, the investigators will conduct a randomized factorial trial phase to test the effect of messaging strategies. Participants will be sent a weekly notification through the eFHS app. Participants will be randomly allocated to one of 8 groups defined according to the following: using personalized reminder messaging vs. standard neutral messaging; notification sent on a weekday vs. weekend; notification sent in the morning vs. the evening. The three main comparisons will be simultaneously evaluated according to a 2x2x2 factorial design.
Interventions
OTHERpersonalized notices
The personalized notices take into account if data were received over the previous week, and accordingly encourages the participant to use the device and send her data, or encourages the participant to continue using the device and sending data. A library of personalized notices with alternative motivational content was developed. Each time a notification is sent, it will be drawn at random from the library.
OTHERstandard notices
The standard notices which are neutral and invite participants to wear the watch daily and to measure their blood pressure weekly.
OTHERam notices
notifications sent at 7 am.
OTHERpm notices
notifications sent at 7 pm.
OTHERweekday notices
notifications sent on Wednesday
OTHERweekend notices
notifications sent on Saturday
Sponsors
Robert Wood Johnson Foundation
Boston University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Masking description
eFHS researchers, statistician, research assistant, and clinic staff are masked to intervention assignment.
Intervention model description
The research design includes a cohort eFHS Study and an embedded randomized factorial trial on a subset of the cohort.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
for the eFHS study: * Participants of the FHS Third Generation, Omni Group 2, and New Offspring Spouse Cohorts attending the in-person examination 3 with access to a smartphone or home internet access and English speaking/reading. Specifically for the RCT substudy (re: engagement with select mobile health technologies): * English-speaking individual * Owns an iPhone with compatible iOS (version 9 or higher); * Residence in the United States * Provision of permissions for notifications and data sharing with the Research Center * Provision of signed and dated informed consent
Exclusion criteria
* Participants who do not meet the inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence at 3 months to the weekly BP recording | 3 months | proportion of participants who submit their weekly blood pressure measurement at 3 months |
| Adherence at 3 months to the weekly HR recording | 3 months | proportion of participants who submit their weekly heart rate measurement at 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence at one month to the weekly BP recording | 1 month | proportion of participants who submit their weekly blood pressure measurement at 1 month |
| Adherence at one month to the weekly HR recording | 1 month | proportion of participants who submit their weekly heart rate measurement at 1 month |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adherence to survey response | 3 months | proportion of participants who complete the eFHS survey at 3 months |
| Adherence at 6 months to the weekly BP recording | 6 months | Comparison between the groups receiving personalized notices to the groups receiving standard notices |
| Adherence at 6 months to the weekly HR recording | 6 months | Comparison between the groups receiving personalized notices to the groups receiving standard notices |
| Adherence at 6 months to survey response | 6 months | Comparison between the groups receiving personalized notices to the groups receiving standard notices |
Countries
United States
Outcome results
None listed