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OpenTrials
Completed

NCT Number: NCT03436082

Post-Market Surveillance With a Novel mHealth Platform

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

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Key information

Conditions

Gastrectomy Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yale New Haven Hospital, New Haven, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

A mobile health platform

Device

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Food and Drug Administration (FDA)
  • Johnson & Johnson
  • Mayo Clinic

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 19, 2018
Registry last updated
Mar 19, 2021

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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