Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

eFHS Messaging Trial

9. februar 2021 oppdatert av: 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.

Studieoversikt

Detaljert beskrivelse

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

Intervensjonell

Registrering (Faktiske)

650

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02118
        • Framingham Heart Study

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Faktoriell oppgave
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Eksperimentell: 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.
Eksperimentell: 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
Eksperimentell: 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
Eksperimentell: 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.
Eksperimentell: 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.
Eksperimentell: 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.
Eksperimentell: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Adherence at 3 months to the weekly BP recording
Tidsramme: 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
Tidsramme: 3 months
proportion of participants who submit their weekly heart rate measurement at 3 months
3 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Adherence at one month to the weekly BP recording
Tidsramme: 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
Tidsramme: 1 month
proportion of participants who submit their weekly heart rate measurement at 1 month
1 month

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Adherence to survey response
Tidsramme: 3 months
proportion of participants who complete the eFHS survey at 3 months
3 months
Adherence at 6 months to the weekly BP recording
Tidsramme: 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
Tidsramme: 6 months
Comparison between the groups receiving personalized notices to the groups receiving standard notices
6 months
Adherence at 6 months to survey response
Tidsramme: 6 months
Comparison between the groups receiving personalized notices to the groups receiving standard notices
6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Samarbeidspartnere

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

19. mai 2018

Primær fullføring (Faktiske)

23. mars 2019

Studiet fullført (Faktiske)

23. mars 2019

Datoer for studieregistrering

Først innsendt

24. april 2018

Først innsendt som oppfylte QC-kriteriene

3. mai 2018

Først lagt ut (Faktiske)

4. mai 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. februar 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. februar 2021

Sist bekreftet

1. februar 2021

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • H-36586
  • 74624 (Annet stipend/finansieringsnummer: Robert Wood Johnson Foundation)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere