Post-Market Surveillance With a Novel mHealth Platform

Completed

• Conditions: Atrial Fibrillation; Gastrectomy
• Interventions: Device: A mobile health platform

• Registration Number: NCT03436082
• Lead Sponsor: Yale University

Brief Summary

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

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 Timeline

• Study Start: 2018-01-26
• Study First Submitted: 2018-01-31
• Study First Submitted QC: 2018-02-15
• Study First Posted: 2018-02-19
• Primary Completion: 2018-12-25
• Study Completion: 2018-12-25
• Results First Submitted: 2021-02-19
• Status Verified: 2021-03
• Results First Submitted QC: 2021-03-18
• Last Update Submitted: 2021-03-18
• Results First Posted: 2021-03-19
• Last Update Posted: 2021-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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Exclusion Criteria

Healthy patients

Patients who refuse participation

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Data from a mobile health platform after atrial fibrillation	A mobile health platform	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.
Data from a mHealth platform after bariatric surgery	A mobile health platform	Patients that have undergone sleeve gastrectomy or gastric bypass will pilot test the use of the patient-led, smartphone based, mhHealth platform HUGO.

Primary Outcome Measures

Name	Time	Method
Electronic Health Record Data Validation	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.
Number of Disease-Specific PROMs Completed	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.
Number of Post-Procedure PROMs Completed	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.
Device Syncs	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.

Trial Locations

Locations (2)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States