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临床试验/NCT03516019
NCT03516019已完成不适用

Messaging Intervention Trial in the Electronic Framingham Heart Study (eFHS)

Boston University2 个研究点 分布在 1 个国家目标入组 650 人开始时间: 2018年5月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
650
试验地点
2
主要终点
Adherence at 3 months to the weekly BP recording

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Single (Investigator)

盲法说明

eFHS researchers, statistician, research assistant, and clinic staff are masked to intervention assignment.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Participants who do not meet the inclusion criteria

结局指标

主要结局

Adherence at 3 months to the weekly BP recording

时间窗: 3 months

proportion of participants who submit their weekly blood pressure measurement at 3 months

Adherence at 3 months to the weekly HR recording

时间窗: 3 months

proportion of participants who submit their weekly heart rate measurement at 3 months

次要结局

  • Adherence at one month to the weekly BP recording(1 month)
  • Adherence at one month to the weekly HR recording(1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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