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eFHS Messaging Trial

9. Februar 2021 aktualisiert von: Boston University

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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

650

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • Massachusetts
      • Boston, Massachusetts, Vereinigte Staaten, 02118
        • Framingham Heart Study

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Fakultätszuweisung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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
Experimental: 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.
Experimental: 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
Experimental: 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
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Adherence at 3 months to the weekly BP recording
Zeitfenster: 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
Zeitfenster: 3 months
proportion of participants who submit their weekly heart rate measurement at 3 months
3 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Adherence at one month to the weekly BP recording
Zeitfenster: 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
Zeitfenster: 1 month
proportion of participants who submit their weekly heart rate measurement at 1 month
1 month

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Adherence to survey response
Zeitfenster: 3 months
proportion of participants who complete the eFHS survey at 3 months
3 months
Adherence at 6 months to the weekly BP recording
Zeitfenster: 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
Zeitfenster: 6 months
Comparison between the groups receiving personalized notices to the groups receiving standard notices
6 months
Adherence at 6 months to survey response
Zeitfenster: 6 months
Comparison between the groups receiving personalized notices to the groups receiving standard notices
6 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Joanne Murabito, MD ScM, Framingham Heart Study

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

19. Mai 2018

Primärer Abschluss (Tatsächlich)

23. März 2019

Studienabschluss (Tatsächlich)

23. März 2019

Studienanmeldedaten

Zuerst eingereicht

24. April 2018

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

3. Mai 2018

Zuerst gepostet (Tatsächlich)

4. Mai 2018

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

11. Februar 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. Februar 2021

Zuletzt verifiziert

1. Februar 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • H-36586
  • 74624 (Andere Zuschuss-/Finanzierungsnummer: Robert Wood Johnson Foundation)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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