Post-Market Surveillance With a Novel mHealth Platform

Atrial Fibrillation Clinical Trial

Official title:

Post-Market Surveillance With a Novel mHealth Platform

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03436082
• Other study ID #: 2000021455
• Status: Completed
• Start date: January 26, 2018
• Est. completion date: December 25, 2018

Study information

• Verified date: March 2021
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 25, 2018
• Est. primary completion date: December 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Gastrectomy

Intervention

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.

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (4)

Lead Sponsor	Collaborator
Yale University	Food and Drug Administration (FDA), Johnson & Johnson, Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

Dhruva SS, Ross JS, Akar JG, Caldwell B, Childers K, Chow W, Ciaccio L, Coplan P, Dong J, Dykhoff HJ, Johnston S, Kellogg T, Long C, Noseworthy PA, Roberts K, Saha A, Yoo A, Shah ND. Aggregating multiple real-world data sources using a patient-centered he — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Disease-Specific PROMs Completed	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
Primary	Number of Post-Procedure PROMs Completed	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
Primary	Device Syncs	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
Primary	Electronic Health Record Data Validation	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