Post-Market Surveillance With a Novel mHealth Platform

NCT ID: NCT03436082

Last Updated: 2021-03-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-26
• Study Completion Date: 2018-12-25

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.

Conditions

Gastrectomy; Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

A mobile health platform

Intervention Type: 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.

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.

A mobile health platform

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson

INDUSTRY

Sponsor Role: collaborator

Food and Drug Administration (FDA)

FED

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph Ross, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Sanket Dhruva, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Nilay Shah, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Yale New Haven Hospital

New Haven, Connecticut, United States

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

References

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 health-data-sharing platform. NPJ Digit Med. 2020 Apr 20;3:60. doi: 10.1038/s41746-020-0265-z. eCollection 2020.

Reference Type: RESULT

PMID: 32352038 (View on PubMed)

Bartlett VL, Ross JS, Shah ND, Ciaccio L, Akar JG, Noseworthy PA, Dhruva SS. Physical activity, patient-reported symptoms, and clinical events: Insights into postprocedural recovery from personal digital devices. Cardiovasc Digit Health J. 2021 Jul 3;2(4):212-221. doi: 10.1016/j.cvdhj.2021.06.002. eCollection 2021 Aug.

Reference Type: DERIVED

PMID: 35265911 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

2000021455

Identifier Type: -

Identifier Source: org_study_id