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eFHS Messaging Trial

9 de febrero de 2021 actualizado por: 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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

650

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02118
        • Framingham Heart Study

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación factorial
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Adherence at 3 months to the weekly BP recording
Periodo de tiempo: 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
Periodo de tiempo: 3 months
proportion of participants who submit their weekly heart rate measurement at 3 months
3 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Adherence at one month to the weekly BP recording
Periodo de tiempo: 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
Periodo de tiempo: 1 month
proportion of participants who submit their weekly heart rate measurement at 1 month
1 month

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Adherence to survey response
Periodo de tiempo: 3 months
proportion of participants who complete the eFHS survey at 3 months
3 months
Adherence at 6 months to the weekly BP recording
Periodo de tiempo: 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
Periodo de tiempo: 6 months
Comparison between the groups receiving personalized notices to the groups receiving standard notices
6 months
Adherence at 6 months to survey response
Periodo de tiempo: 6 months
Comparison between the groups receiving personalized notices to the groups receiving standard notices
6 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Joanne Murabito, MD ScM, Framingham Heart Study

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

19 de mayo de 2018

Finalización primaria (Actual)

23 de marzo de 2019

Finalización del estudio (Actual)

23 de marzo de 2019

Fechas de registro del estudio

Enviado por primera vez

24 de abril de 2018

Primero enviado que cumplió con los criterios de control de calidad

3 de mayo de 2018

Publicado por primera vez (Actual)

4 de mayo de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

11 de febrero de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

9 de febrero de 2021

Última verificación

1 de febrero de 2021

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • H-36586
  • 74624 (Otro número de subvención/financiamiento: Robert Wood Johnson Foundation)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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