Clinical trial NCT04752657: Second eFramngham Heart Study
Official title: eFramingham Heart Study Randomized Controlled Trial #2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Framingham Heart Sudy
eFHS
mhealth
patient provider communication
user engagement
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-02-12
Enrollment: 492
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each participant will be randomized to one of the 2 groups. A statistician will generate randomization lists with the use of randomly permuted blocks of varying sizes, with stratification according to participant's age (≤75 years vs. \>75 years) and type of phone (android vs. iphone). Randomization will be implemented centrally through the app.
Primary purpose: PREVENTION

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Surveys/Tasks Returned in Period 1
timeFrame: baseline, up to week 8
measure: Proportion of Surveys/Tasks Returned in Period 2
timeFrame: week 8, up to week 16
measure: Proportion of Surveys/Tasks Returned in Period 3
timeFrame: week 16, up to week 24
measure: Proportion of Surveys/Tasks Returned in Period 4
timeFrame: week 24, to completion of study usually 26 weeks
Secondary outcomes:
measure: Proportion of Questions/Task Completed Per Participant in Period 1
timeFrame: baseline, up to week 8
measure: Proportion of Questions/Task Completed Per Participant in Period 2
timeFrame: week 8, up to week 16
measure: Proportion of Questions/Task Completed Per Participant in Period 3
timeFrame: week 16, up to week 24
measure: Proportion of Questions/Task Completed Per Participant in Period 4
timeFrame: week 24, to completion of study usually 26 weeks
Other outcomes:
Locations:
city: Framingham
country: United States
facility: Framingham Heart Study
state: Massachusetts
Study officials:
affiliation: Framingham Heart Study
name: Joanne Murabito
role: PRINCIPAL_INVESTIGATOR
References: