Cardiovascular DiseasesNCT03516019
eFHS Messaging Trial
A study testing personalized notices, standard notices and am notices in people with Cardiovascular Diseases, run by Boston University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- personalized notices, standard notices and am notices
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2018to 23 Mar 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participants who do not meet the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Messaging Intervention Trial in the Electronic Framingham Heart Study (eFHS)
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.
Read the 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.
- Conditions
- Cardiovascular Diseases
- Being tested
- personalized notices, standard notices, am notices, pm notices, weekday notices
- Keywords
- mHealth, digital BP monitoring, patient provider communication, smart watch, user engagement, population health data
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
personalized noticesOther
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.
standard noticesOther
The standard notices which are neutral and invite participants to wear the watch daily and to measure their blood pressure weekly.
am noticesOther
notifications sent at 7 am.
pm noticesOther
notifications sent at 7 pm.
weekday noticesOther
notifications sent on Wednesday
weekend noticesOther
notifications sent on Saturday
| Study group | Role | What they receive |
|---|---|---|
| Weekday am personalized notices | Experimental | Participants in this arm receive personalized weekday am notices on Wednesday at 7am. Receives: Other: personalized notices; Other: am notices; Other: weekday notices |
| Weekday pm personalized notices | Experimental | Participants in this arm receive a personalized weekday pm notices on Wednesday at 7pm. Receives: Other: personalized notices; Other: pm notices; Other: weekday notices |
| Weekend am personalized notices | Experimental | Participants in this arm receive a personalized weekend am notices on Saturday at 7am. Receives: Other: personalized notices; Other: am notices; Other: weekend notices |
| Weekend pm personalized notices | Experimental | Participants in this arm receive personalized pm notices on Saturday at 7pm. Receives: Other: personalized notices; Other: pm notices; Other: weekend notices |
| Weekday am standard notices | Experimental | Participants in this arm receive standard weekday notices on Wednesday at 7am. Receives: Other: standard notices; Other: am notices; Other: weekday notices |
| Weekday pm standard notices | Experimental | Participants in this arm receive standard weekday notices on Wednesday at 7pm Receives: Other: standard notices; Other: pm notices; Other: weekday notices |
| Weekend am standard notices | Experimental | Participants in this arm receive standard weekend notices on Saturday at 7am Receives: Other: standard notices; Other: am notices; Other: weekend notices |
| Weekend pm standard notices | Experimental | Participants in this arm receive standard weekend notices on Saturday at 7pm Receives: Other: standard notices; Other: pm notices; Other: weekend notices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence at 3 months to the weekly BP recording
proportion of participants who submit their weekly blood pressure measurement at 3 months
Measured: 3 months
Adherence at 3 months to the weekly HR recording
proportion of participants who submit their weekly heart rate measurement at 3 months
Measured: 3 months
Secondary outcomes (2)
Adherence at one month to the weekly BP recording
proportion of participants who submit their weekly blood pressure measurement at 1 month
Measured: 1 month
Adherence at one month to the weekly HR recording
proportion of participants who submit their weekly heart rate measurement at 1 month
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start19 May 2018
- Primary completion23 Mar 2019
- Study completion23 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The research design includes a cohort eFHS Study and an embedded randomized factorial trial on a subset of the cohort.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 650 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Responsible party
- Sponsor
- Investigators
- Joanne Murabito, MD ScM, Principal investigator, Framingham Heart Study
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516019
- Sponsor's protocol ID
- H-36586
- Other IDs
- 74624
- Status last verified
- Feb 2021
- First submitted
- 24 Apr 2018
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Trinquart L, Liu C, McManus DD, Nowak C, Lin H, Spartano NL, Borrelli B, Benjamin EJ, Murabito JM. Increasing Engagement in the Electronic Framingham Heart Study: Factorial Randomized Controlled Trial. J Med Internet Res. 2023 Jan 20;25:e40784. doi: 10.2196/40784.
PubMed 36662544
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Messaging Intervention Trial in the Electronic Framingham Heart Study (eFHS)
- ClinicalTrials.gov ID
- NCT03516019
- Acronym / sponsor ID
- H-36586
- Conditions
- Cardiovascular Diseases
- Keywords
- mHealth, digital BP monitoring, patient provider communication, smart watch, user engagement, population health data
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 650 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- 19 May 2018 (actual)
- Primary completion
- 23 Mar 2019 (actual)
- Study completion
- 23 Mar 2019 (actual)
- First posted
- 4 May 2018 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 8
- Model description
- The research design includes a cohort eFHS Study and an embedded randomized factorial trial on a subset of the cohort.
| Arm | Type | Receives |
|---|---|---|
| Weekday am personalized notices | Experimental | Other: personalized notices, Other: am notices, Other: weekday noticesParticipants in this arm receive personalized weekday am notices on Wednesday at 7am. |
| Weekday pm personalized notices | Experimental | Other: personalized notices, Other: pm notices, Other: weekday noticesParticipants in this arm receive a personalized weekday pm notices on Wednesday at 7pm. |
| Weekend am personalized notices | Experimental | Other: personalized notices, Other: am notices, Other: weekend noticesParticipants in this arm receive a personalized weekend am notices on Saturday at 7am. |
| Weekend pm personalized notices | Experimental | Other: personalized notices, Other: pm notices, Other: weekend noticesParticipants in this arm receive personalized pm notices on Saturday at 7pm. |
| Weekday am standard notices | Experimental | Other: standard notices, Other: am notices, Other: weekday noticesParticipants in this arm receive standard weekday notices on Wednesday at 7am. |
| Weekday pm standard notices | Experimental | Other: standard notices, Other: pm notices, Other: weekday noticesParticipants in this arm receive standard weekday notices on Wednesday at 7pm |
| Weekend am standard notices | Experimental | Other: standard notices, Other: am notices, Other: weekend noticesParticipants in this arm receive standard weekend notices on Saturday at 7am |
| Weekend pm standard notices | Experimental | Other: standard notices, Other: pm notices, Other: weekend noticesParticipants in this arm receive standard weekend notices on Saturday at 7pm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Participants who do not meet the inclusion criteria
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 |
|---|---|---|
| personalized noticesThe 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. | Other | Weekday am personalized notices, Weekday pm personalized notices, Weekend am personalized notices, Weekend pm personalized notices |
| standard noticesThe standard notices which are neutral and invite participants to wear the watch daily and to measure their blood pressure weekly. | Other | Weekday am standard notices, Weekday pm standard notices, Weekend am standard notices, Weekend pm standard notices |
| am noticesnotifications sent at 7 am. | Other | Weekday am personalized notices, Weekday am standard notices, Weekend am personalized notices, Weekend am standard notices |
| pm noticesnotifications sent at 7 pm. | Other | Weekday pm personalized notices, Weekday pm standard notices, Weekend pm personalized notices, Weekend pm standard notices |
| weekday noticesnotifications sent on Wednesday | Other | Weekday am personalized notices, Weekday am standard notices, Weekday pm personalized notices, Weekday pm standard notices |
| weekend noticesnotifications sent on Saturday | Other | Weekend am personalized notices, Weekend am standard notices, Weekend pm personalized notices, Weekend pm standard notices |
Primary outcome
Adherence at 3 months to the weekly BP recording
Time frame: 3 months
proportion of participants who submit their weekly blood pressure measurement at 3 months
Adherence at 3 months to the weekly HR recording
Time frame: 3 months
proportion of participants who submit their weekly heart rate measurement at 3 months
2 secondary outcomes
Adherence at one month to the weekly BP recording
Time frame: 1 month
Adherence at one month to the weekly HR recording
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Derived from this study: PubMed 36662544Trinquart L, Liu C, McManus DD, Nowak C, Lin H, Spartano NL, Borrelli B, Benjamin EJ, Murabito JM. Increasing Engagement in the Electronic Framingham Heart Study: Factorial Randomized Controlled Trial. J Med Internet Res. 2023 Jan 20;25:e40784. doi: 10.2196/40784.
- Individual participant dataSharing planned: No
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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.
Joanne Murabito, MD ScM principal investigator
Framingham Heart Study
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing personalized notices, standard notices and am notices in people with Cardiovascular Diseases, run by Boston 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 7 inclusion and 1 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: finished, as of the sponsor's last update on 11 Feb 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adherence at 3 months to the weekly BP recording (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT03516019, which also lists 1 linked publication.
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 11 Feb 2021.