Cardiovascular Diseases
Conditions
Keywords
Framingham Heart Sudy, eFHS, mhealth, patient provider communication, user engagement
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.
Interventions
OTHERDelayed administration of survey modules
The intervention consists in delaying the administration of the physical function, physical activity, and events survey modules by 2 weeks
OTHERRegular administration of survey modules
The physical function, physical activity, and events survey modules are administered according to the regular pattern
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Boston University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Surveys/Tasks Returned in Period 4 | 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. |
| Proportion of Surveys/Tasks Returned in Period 1 | 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. |
| Proportion of Surveys/Tasks Returned in Period 2 | 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. |
| Proportion of Surveys/Tasks Returned in Period 3 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Questions/Task Completed Per Participant in Period 1 | 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. |
| Proportion of Questions/Task Completed Per Participant in Period 2 | 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. |
| Proportion of Questions/Task Completed Per Participant in Period 3 | 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. |
| Proportion of Questions/Task Completed Per Participant in Period 4 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental- Two-week Group Delayed administration of the physical function, physical activity, and events survey modules by 2 weeks. | 248 |
| Control- Four-week Group The physical function, physical activity, and events survey modules are administered according to the regular 4-week pattern. | 244 |
| Total | 492 |
Baseline characteristics
| Characteristic | Experimental- Two-week Group | Control- Four-week Group | Total |
|---|---|---|---|
| Age, Continuous | 74.0 years STANDARD_DEVIATION 6.2 | 73.9 years STANDARD_DEVIATION 6.3 | 73.9 years STANDARD_DEVIATION 6.3 |
| Race/Ethnicity, Customized Other | 39 Participants | 39 Participants | 78 Participants |
| Race/Ethnicity, Customized White | 209 Participants | 205 Participants | 414 Participants |
| Region of Enrollment United States | 248 participants | 244 participants | 492 participants |
| Sex: Female, Male Female | 148 Participants | 136 Participants | 284 Participants |
| Sex: Female, Male Male | 100 Participants | 108 Participants | 208 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 248 | 0 / 244 |
| other Total, other adverse events | 0 / 248 | 0 / 244 |
| serious Total, serious adverse events | 0 / 248 | 0 / 244 |
Outcome results
Primary
Proportion of Surveys/Tasks Returned in Period 1
Proportion of surveys/task returned per participant (partially or fully completed) from baseline, up to week 8, will be documented on the eFHS app.
Time frame: baseline, up to week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental- Two-week Group | Proportion of Surveys/Tasks Returned in Period 1 | 0.85 proportion of surveys returned | Standard Deviation 0.28 |
| Control- Four-week Group | Proportion of Surveys/Tasks Returned in Period 1 | 0.85 proportion of surveys returned | Standard Deviation 0.29 |
Primary
Proportion of Surveys/Tasks Returned in Period 2
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.
Time frame: week 8, up to week 16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental- Two-week Group | Proportion of Surveys/Tasks Returned in Period 2 | 0.75 proportion of surveys returned | Standard Deviation 0.4 |
| Control- Four-week Group | Proportion of Surveys/Tasks Returned in Period 2 | 0.72 proportion of surveys returned | Standard Deviation 0.42 |
Primary
Proportion of Surveys/Tasks Returned in Period 3
Proportion of surveys/task returned per participant (partially or fully completed) week 16, up to week 24, will be documented on the eFHS app.
Time frame: week 16, up to week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental- Two-week Group | Proportion of Surveys/Tasks Returned in Period 3 | 0.71 proportion of surveys returned | Standard Deviation 0.43 |
| Control- Four-week Group | Proportion of Surveys/Tasks Returned in Period 3 | 0.67 proportion of surveys returned | Standard Deviation 0.45 |
Primary
Proportion of Surveys/Tasks Returned in Period 4
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.
Time frame: week 24, to completion of study usually 26 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental- Two-week Group | Proportion of Surveys/Tasks Returned in Period 4 | 0.66 proportion of surveys returned | Standard Deviation 0.44 |
| Control- Four-week Group | Proportion of Surveys/Tasks Returned in Period 4 | 0.59 proportion of surveys returned | Standard Deviation 0.47 |
Secondary
Proportion of Questions/Task Completed Per Participant in Period 1
Proportion of questions/task completed per participant from all survey modules administered from baseline to week 8, will be documented on the eFHS app.
Time frame: baseline, up to week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental- Two-week Group | Proportion of Questions/Task Completed Per Participant in Period 1 | 0.86 proportion of questions completed | Standard Deviation 0.28 |
| Control- Four-week Group | Proportion of Questions/Task Completed Per Participant in Period 1 | 0.88 proportion of questions completed | Standard Deviation 0.29 |
Secondary
Proportion of Questions/Task Completed Per Participant in Period 2
Proportion of questions/task completed per participant from week 8 to week 16, will be documented on the eFHS app.
Time frame: week 8, up to week 16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental- Two-week Group | Proportion of Questions/Task Completed Per Participant in Period 2 | 0.77 proportion of questions completed | Standard Deviation 0.4 |
| Control- Four-week Group | Proportion of Questions/Task Completed Per Participant in Period 2 | 0.74 proportion of questions completed | Standard Deviation 0.42 |
Secondary
Proportion of Questions/Task Completed Per Participant in Period 3
Proportion of questions/task completed per participant from week 16 to week 24, will be documented on the eFHS app.
Time frame: week 16, up to week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental- Two-week Group | Proportion of Questions/Task Completed Per Participant in Period 3 | 0.73 proportion of questions completed | Standard Deviation 0.43 |
| Control- Four-week Group | Proportion of Questions/Task Completed Per Participant in Period 3 | 0.70 proportion of questions completed | Standard Deviation 0.45 |
Secondary
Proportion of Questions/Task Completed Per Participant in Period 4
Proportion of questions/task completed per participant from week 24 to study completion, will be documented on the eFHS app.
Time frame: week 24, to completion of study usually 26 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental- Two-week Group | Proportion of Questions/Task Completed Per Participant in Period 4 | 0.68 proportion of questions completed | Standard Deviation 0.44 |
| Control- Four-week Group | Proportion of Questions/Task Completed Per Participant in Period 4 | 0.61 proportion of questions completed | Standard Deviation 0.47 |