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Completed

NCT Number: NCT04752657

Second eFramngham Heart Study

In the electronic Framingham Heart Study (eFHS), the investigators developed and deployed a mobile app to collect cardiovascular risk factors and event data and test them against cardiovascular data collected in the Framingham research clinic for the FHS.

Participants enrolled in eFHS receive a series of digital surveys modules to complete on a regularly occurring schedule. The objective of the planned randomized trial is to test the effect of administering half of survey modules every 2 weeks versus all survey modules every 4 weeks on improving participants' response rates.

There will be 4 survey periods. Period 1 encompasses all survey modules administered from baseline up to week 8 (19 surveys/tasks per participant); period 2 from week 8 up to week 16 (18 surveys/tasks per participant); period 3 from week 16 up to week 24; period 4 from week 24 (16 surveys/tasks per participant).

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Key information

Conditions

Cardiovascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Framingham Heart Study

Framingham, Massachusetts, 01702, United States

About this study

Participants in eFHS are invited to enroll from the FHS Offspring and Omni Group 1 Cohorts during the in-person examination 10/5 at the FHS Research Center in Framingham, Massachusetts (MA), USA or remotely from home after the in-person examination. All eFHS participants have the eFHS myDataHelps mobile app (developed by FHS investigators with CareEvolution our industry partner) installed on their smartphone. The eFHS app allows communication with participants through notifications and data collection. Participants are asked to answer health surveys administered through the app.

Survey assessments will include 6 modules: cognition, pain, mood, physical function and performance, physical activity, and events. The interventions are defined by the patterns of administration of survey modules to the experimental and control groups. The administration of the cognition, pain, mood, and psychosocial modules follow the same pattern for both groups. However, the administration of the physical function, physical activity, and events modules is delayed by 2 weeks in the experimental group as compared to the control group.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Invited to enroll from the FHS Offspring and Omni Group 1 Cohorts during the in-person examination 10/5 at the FHS Research Center
  • English speaking
  • English language reading proficiency
  • Owns an iPhone with compatible iOS (version 10.0 or higher) or Android (version 5.0 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 (within the eFHS mobile app)

Exclusion criteria

  • Limited and non-readers

Treatment and study plan

Delayed administration of survey modules

Other

The intervention consists in delaying the administration of the physical function, physical activity, and events survey modules by 2 weeks

Regular administration of survey modules

Other

The physical function, physical activity, and events survey modules are administered according to the regular pattern

Primary outcomes

  1. Proportion of Surveys/Tasks Returned in Period 1

    Time frame: baseline, up to week 8

    Proportion of surveys/task returned per participant (partially or fully completed) from baseline, up to week 8, will be documented on the eFHS app.

  2. Proportion of Surveys/Tasks Returned in Period 2

    Time frame: week 8, up to week 16

    Proportion of surveys/task returned per participant (partially or fully completed) from week 8, up to week 16, will be documented on the eFHS app.

  3. Proportion of Surveys/Tasks Returned in Period 3

    Time frame: week 16, up to week 24

    Proportion of surveys/task returned per participant (partially or fully completed) week 16, up to week 24, will be documented on the eFHS app.

  4. Proportion of Surveys/Tasks Returned in Period 4

    Time frame: week 24, to completion of study usually 26 weeks

    Proportion of surveys/task returned per participant (partially or fully completed) week 24, to completion of study usually 26 weeks, will be documented on the eFHS app.

Secondary outcomes

  1. Proportion of Questions/Task Completed Per Participant in Period 1

    Time frame: baseline, up to week 8

    Proportion of questions/task completed per participant from all survey modules administered from baseline to week 8, will be documented on the eFHS app.

  2. Proportion of Questions/Task Completed Per Participant in Period 2

    Time frame: week 8, up to week 16

    Proportion of questions/task completed per participant from week 8 to week 16, will be documented on the eFHS app.

  3. Proportion of Questions/Task Completed Per Participant in Period 3

    Time frame: week 16, up to week 24

    Proportion of questions/task completed per participant from week 16 to week 24, will be documented on the eFHS app.

  4. Proportion of Questions/Task Completed Per Participant in Period 4

    Time frame: week 24, to completion of study usually 26 weeks

    Proportion of questions/task completed per participant from week 24 to study completion, will be documented on the eFHS app.

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

eFramingham Heart Study Randomized Controlled Trial #2

Acronym: eFHS-2

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 12, 2021
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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