Post-Market Surveillance With a Novel mHealth Platform

Yale University

Status: Completed

Conditions: Atrial Fibrillation; Gastrectomy

Treatments: Device: A mobile health platform

Study type: Observational

Funder types: Other; Industry; Other U.S. Federal agency

Identifiers

NCT03436082

2000021455

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

Data from a mHealth platform after bariatric surgery

Description:

Patients that have undergone sleeve gastrectomy or gastric bypass will pilot test the use of the patient-led, smartphone based, mhHealth platform HUGO.

Treatment:

Device: A mobile health platform

Data from a mobile health platform after atrial fibrillation

Description:

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.

Treatment:

Device: A mobile health platform