Post-Market Surveillance With a Novel mHealth Platform

March 18, 2021 updated by: Yale University
This is a study to pilot the feasibility of using a novel patient-led, smartphone-based mobile health platform (Hugo) for real-world surveillance of outcomes of patients after they undergo a bariatric surgical procedure (either sleeve gastrectomy or gastric bypass) and catheter-based atrial fibrillation ablation

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The plan is to pilot test a novel patient-led, smartphone-based mobile health platform (called Hugo) for real-world surveillance of outcomes in 60 total patients after medical device use. Research associates will be recruiting patients before they undergo a bariatric surgical procedure (either sleeve gastrectomy or gastric bypass) and catheter-based atrial fibrillation ablation. Patients will then be queried about specific symptoms related to their procedure. Patients will also be given syncable devices to use that will provide additional insights into their health and health outcomes. This pilot project will engage patients to report outcomes while also synchronizing data from their electronic health records and pharmacy accounts to ascertain the ability of emerging mobile health technologies to aid in post-marketing surveillance.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale New Haven Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A patient's eligibility will first be determined by the implanting physician who will be performing the catheter-based atrial fibrillation ablation or bariatric surgical procedure (either sleeve gastrectomy or gastric bypass). The criterion used will simply be the cardiac electrophysiologist stating that the patient is being seen pre-procedurally for catheter ablation of atrial fibrillation or the bariatric surgeon stating that the patient is being seen pre-operatively for sleeve gastrectomy or gastric bypass.

Description

Inclusion Criteria:

  • Age >18
  • English-speaking
  • Planned for either a bariatric surgical procedure (either sleeve gastrectomy or gastric bypass) or catheter-based atrial fibrillation ablation
  • Participant is willing and able to read and sign consent and participate in study
  • Participant has an email account and a mobile device (smartphone or tablet) able to download the necessary applications
  • Participant is willing to use the mobile health platform and syncable devices (e.g. Fitbit Charge 2)
  • Attending bariatric surgeon or electrophysiologist (as appropriate) concurs that patient is a candidate for enrollment

Exclusion Criteria:

Healthy patients

Patients who refuse participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Data from a mHealth platform after bariatric surgery
Patients that have undergone sleeve gastrectomy or gastric bypass will pilot test the use of the patient-led, smartphone based, mhHealth platform HUGO.
Device: A mobile health platform
Patients pilot testing the smartphone based, mobile health platform called HUGO. Patients will also be given syncable devices to use that will provide additional insights into their health and health outcomes.Patients will be queried about specific symptoms related to their procedure at enrollment, one week post-procedure, at 4 weeks and again at 8 weeks.
Data from a mobile health platform after atrial fibrillation
Patients that have undergone a catheter-based atrial fibrillation ablation will pilot test the use of the patient-led, smartphone based, mobile health platform HUGO.
Device: A mobile health platform
Patients pilot testing the smartphone based, mobile health platform called HUGO. Patients will also be given syncable devices to use that will provide additional insights into their health and health outcomes.Patients will be queried about specific symptoms related to their procedure at enrollment, one week post-procedure, at 4 weeks and again at 8 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Disease-Specific PROMs Completed
Time Frame: 8 weeks
Disease-specific PROMs were collected using email notification to all patients over the course of the study. Disease-specific PROMs were emailed to patients at enrollment (preprocedure) and 1, 4, and 8 weeks post-procedure and were tailored to patients depending on the procedure they received. For each PROM, the date and time that it was emailed to patients, the time it was initiated, and the time at which the final response was received were all available.
8 weeks
Number of Post-Procedure PROMs Completed
Time Frame: 5 weeks
Post-procedure PROMs were collected using email notification to all patients over the course of the study. Post-procedure PROMs were emailed to patients twice weekly for a total of 5 weeks post-procedure. Bariatric surgery patients were asked two questions: (1) if they had pain (yes/no) and, if yes, to rate their pain on a scale of 1-10 and (2) if they had an appetite (yes/no) and, if yes, to rate their appetite on a scale of 1-10. Atrial fibrillation ablation patients were asked about pain, as well as whether they had palpitations and, if yes, to rate both symptoms on a scale of 1-10. For each PROM, the date and time that it was emailed to patients, the time it was initiated, and the time at which the final response was received were all available.
5 weeks
Device Syncs
Time Frame: 8 weeks
Device syncs are operationally defined as the # of patients who synced their device at all required time points over the 8-week post-procedure period.
8 weeks
Electronic Health Record Data Validation
Time Frame: 8 weeks
For EHR data, we validated the following components over 8 weeks follow-up: encounter date, encounter type, and encounter primary diagnosis. Specifically, we determined if encounters aggregated by the patient-centered health data sharing platform, Hugo, matched encounters listed in each patient's EHR.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Mayo Clinic
Johnson & Johnson
Food and Drug Administration (FDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joseph Ross, MD, Yale University
  • Principal Investigator: Sanket Dhruva, MD, Yale University
  • Principal Investigator: Nilay Shah, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 26, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 25, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 25, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2000021455

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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