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eFHS Messaging Trial

2021년 2월 9일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (실제)

650

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Massachusetts
      • Boston, Massachusetts, 미국, 02118
        • Framingham Heart Study

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 요인 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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
실험적: 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.
실험적: 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
실험적: 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
실험적: 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.
실험적: 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.
실험적: 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.
실험적: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Adherence at 3 months to the weekly BP recording
기간: 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
기간: 3 months
proportion of participants who submit their weekly heart rate measurement at 3 months
3 months

2차 결과 측정

결과 측정
측정값 설명
기간
Adherence at one month to the weekly BP recording
기간: 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
기간: 1 month
proportion of participants who submit their weekly heart rate measurement at 1 month
1 month

기타 결과 측정

결과 측정
측정값 설명
기간
Adherence to survey response
기간: 3 months
proportion of participants who complete the eFHS survey at 3 months
3 months
Adherence at 6 months to the weekly BP recording
기간: 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
기간: 6 months
Comparison between the groups receiving personalized notices to the groups receiving standard notices
6 months
Adherence at 6 months to survey response
기간: 6 months
Comparison between the groups receiving personalized notices to the groups receiving standard notices
6 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 수석 연구원: Joanne Murabito, MD ScM, Framingham Heart Study

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2018년 5월 19일

기본 완료 (실제)

2019년 3월 23일

연구 완료 (실제)

2019년 3월 23일

연구 등록 날짜

최초 제출

2018년 4월 24일

QC 기준을 충족하는 최초 제출

2018년 5월 3일

처음 게시됨 (실제)

2018년 5월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 2월 11일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 2월 9일

마지막으로 확인됨

2021년 2월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • H-36586
  • 74624 (기타 보조금/기금 번호: Robert Wood Johnson Foundation)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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