eFHS Messaging Trial
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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02118
- Framingham Heart Study
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-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Faculteitstoewijzing
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Weekday am personalized notices
Participants in this arm receive personalized weekday am notices on Wednesday at 7am.
|
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.
notifications sent at 7 am.
notifications sent on Wednesday
|
|
Experimenteel: Weekday pm personalized notices
Participants in this arm receive a personalized weekday pm notices on Wednesday at 7pm.
|
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.
notifications sent on Wednesday
notifications sent at 7 pm.
|
|
Experimenteel: Weekend am personalized notices
Participants in this arm receive a personalized weekend am notices on Saturday at 7am.
|
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.
notifications sent at 7 am.
notifications sent on Saturday
|
|
Experimenteel: Weekend pm personalized notices
Participants in this arm receive personalized pm notices on Saturday at 7pm.
|
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.
notifications sent at 7 pm.
notifications sent on Saturday
|
|
Experimenteel: Weekday am standard notices
Participants in this arm receive standard weekday notices on Wednesday at 7am.
|
notifications sent at 7 am.
notifications sent on Wednesday
The standard notices which are neutral and invite participants to wear the watch daily and to measure their blood pressure weekly.
|
|
Experimenteel: Weekday pm standard notices
Participants in this arm receive standard weekday notices on Wednesday at 7pm
|
notifications sent on Wednesday
notifications sent at 7 pm.
The standard notices which are neutral and invite participants to wear the watch daily and to measure their blood pressure weekly.
|
|
Experimenteel: Weekend am standard notices
Participants in this arm receive standard weekend notices on Saturday at 7am
|
notifications sent at 7 am.
notifications sent on Saturday
The standard notices which are neutral and invite participants to wear the watch daily and to measure their blood pressure weekly.
|
|
Experimenteel: Weekend pm standard notices
Participants in this arm receive standard weekend notices on Saturday at 7pm
|
notifications sent at 7 pm.
notifications sent on Saturday
The standard notices which are neutral and invite participants to wear the watch daily and to measure their blood pressure weekly.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Adherence at 3 months to the weekly BP recording
Tijdsspanne: 3 months
|
proportion of participants who submit their weekly blood pressure measurement at 3 months
|
3 months
|
|
Adherence at 3 months to the weekly HR recording
Tijdsspanne: 3 months
|
proportion of participants who submit their weekly heart rate measurement at 3 months
|
3 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Adherence at one month to the weekly BP recording
Tijdsspanne: 1 month
|
proportion of participants who submit their weekly blood pressure measurement at 1 month
|
1 month
|
|
Adherence at one month to the weekly HR recording
Tijdsspanne: 1 month
|
proportion of participants who submit their weekly heart rate measurement at 1 month
|
1 month
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Adherence to survey response
Tijdsspanne: 3 months
|
proportion of participants who complete the eFHS survey at 3 months
|
3 months
|
|
Adherence at 6 months to the weekly BP recording
Tijdsspanne: 6 months
|
Comparison between the groups receiving personalized notices to the groups receiving standard notices
|
6 months
|
|
Adherence at 6 months to the weekly HR recording
Tijdsspanne: 6 months
|
Comparison between the groups receiving personalized notices to the groups receiving standard notices
|
6 months
|
|
Adherence at 6 months to survey response
Tijdsspanne: 6 months
|
Comparison between the groups receiving personalized notices to the groups receiving standard notices
|
6 months
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Joanne Murabito, MD ScM, Framingham Heart Study
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- H-36586
- 74624 (Ander subsidie-/financieringsnummer: Robert Wood Johnson Foundation)
Plan Individuele Deelnemersgegevens (IPD)
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Informatie over medicijnen en apparaten, studiedocumenten
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