Cardiovascular DiseaseseFHS-2NCT04752657
Second eFramngham Heart Study
A study testing Delayed administration of survey modules and Regular administration of survey modules in people with Cardiovascular Diseases, run by Boston University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Delayed administration of survey modules and Regular administration of survey modules
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 492 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2021to 28 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Limited and non-readers
Trial locations and contacts
1 site in 1 country.
United States1 site
Framingham Heart Study
Framingham, Massachusetts, 01702
About this study
Official title: eFramingham Heart Study Randomized Controlled Trial #2
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).
Read the 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.
- Conditions
- Cardiovascular Diseases
- Being tested
- Delayed administration of survey modules, Regular administration of survey modules
- Keywords
- Framingham Heart Sudy, eFHS, mhealth, patient provider communication, user engagement
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delayed administration of survey modulesOther
The intervention consists in delaying the administration of the physical function, physical activity, and events survey modules by 2 weeks
Regular administration of survey modulesOther
The physical function, physical activity, and events survey modules are administered according to the regular pattern
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The experimental group will receive the physical function survey at weeks 2, 10, 18, and 26; the physical activity survey at weeks 2, 14, and 26; the events survey at weeks 2, 6, 10, 14, 18, 22, and 26. The administration of the cognition, pain, mood, and psychosocial surveys follow the same pattern for both groups. Receives: Other: Delayed administration of survey modules |
| Control Group | Active comparator | The control group will receive the physical function survey at weeks 0, 8, 16, and 24; the physical activity survey at weeks 0, 12, and 24; the events survey at weeks 0, 4, 8, 12, 16, 20, and 24. The administration of the cognition, pain, mood, and psychosocial surveys follow the same pattern for both groups. Receives: Other: Regular administration of survey modules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, up to week 8
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.
Measured: week 8, up to week 16
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.
Measured: week 16, up to week 24
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.
Measured: week 24, to completion of study usually 26 weeks
Secondary outcomes (4)
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.
Measured: baseline, up to week 8
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.
Measured: week 8, up to week 16
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.
Measured: week 16, up to week 24
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.
Measured: week 24, to completion of study usually 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start21 Jun 2021
- Primary completion28 Dec 2023
- Study completion28 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 492 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Joanne Murabito, Principal investigator, Framingham Heart Study
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04752657
- Sponsor's protocol ID
- H-40737
- Other IDs
- 5R01HL141434-03
- Acronym
- eFHS-2
- Status last verified
- Feb 2025
- First submitted
- 9 Feb 2021
- Last updated
- 19 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated and analyzed during this study are available from the research team upon reasonable request.
Publications
Zhang Y, Rong J, Wang X, Schramm E, Pathiravasan CH, Borrelli B, Faro JM, Benjamin EJ, Trinquart L, Liu C, Murabito JM. Smartphone App-Based Survey Deployment Patterns and Longitudinal Response Rate: Randomized Controlled Trial. J Med Internet Res. 2025 Oct 10;27:e73972. doi: 10.2196/73972.
PubMed 41071587
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- eFramingham Heart Study Randomized Controlled Trial #2
- ClinicalTrials.gov ID
- NCT04752657
- Acronym / sponsor ID
- eFHS-2 / H-40737
- Conditions
- Cardiovascular Diseases
- Keywords
- Framingham Heart Sudy, eFHS, mhealth, patient provider communication, user engagement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 492 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 28 Dec 2023 (actual)
- Study completion
- 28 Dec 2023 (actual)
- First posted
- 12 Feb 2021 (actual)
- Results
- Posted 19 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Delayed administration of survey modulesThe experimental group will receive the physical function survey at weeks 2, 10, 18, and 26; the physical activity survey at weeks 2, 14, and 26; the events survey at weeks 2, 6, 10, 14, 18, 22, and 26. The administration of the cognition, pain, mood, and psychosocial surveys follow the same pattern for both groups. |
| Control Group | Active comparator | Other: Regular administration of survey modulesThe control group will receive the physical function survey at weeks 0, 8, 16, and 24; the physical activity survey at weeks 0, 12, and 24; the events survey at weeks 0, 4, 8, 12, 16, 20, and 24. The administration of the cognition, pain, mood, and psychosocial surveys follow the same pattern for both groups. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Limited and non-readers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delayed administration of survey modulesThe intervention consists in delaying the administration of the physical function, physical activity, and events survey modules by 2 weeks | Other | Experimental Group |
| Regular administration of survey modulesThe physical function, physical activity, and events survey modules are administered according to the regular pattern | Other | Control Group |
Primary outcome
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.
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.
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.
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.
4 secondary outcomes
Proportion of Questions/Task Completed Per Participant in Period 1
Time frame: baseline, up to week 8
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 in Period 3
Time frame: week 16, up to week 24
Proportion of Questions/Task Completed Per Participant in Period 4
Time frame: week 24, to completion of study usually 26 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41071587Zhang Y, Rong J, Wang X, Schramm E, Pathiravasan CH, Borrelli B, Faro JM, Benjamin EJ, Trinquart L, Liu C, Murabito JM. Smartphone App-Based Survey Deployment Patterns and Longitudinal Response Rate: Randomized Controlled Trial. J Med Internet Res. 2025 Oct 10;27:e73972. doi: 10.2196/73972.
- Individual participant dataSharing planned: Yes. The datasets generated and analyzed during this study are available from the research team upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanne Murabito principal investigator
Framingham Heart Study
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delayed administration of survey modules and Regular administration of survey modules in people with Cardiovascular Diseases, run by Boston University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Surveys/Tasks Returned in Period 1 (time frame: baseline, up to week 8). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04752657, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.