Clinical trial NCT03436082: Post-Market Surveillance With a Novel mHealth Platform
Official title: Post-Market Surveillance With a Novel mHealth Platform
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrectomy
Atrial Fibrillation
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson
name: Food and Drug Administration (FDA)
name: Mayo Clinic
First posted: 2018-02-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A patient's eligibility will first be determined by the implanting physician who will be performing the catheter-based atrial fibrillation ablation or bariatric surgical procedure (either sleeve gastrectomy or gastric bypass). The criterion used will simply be the cardiac electrophysiologist stating that the patient is being seen pre-procedurally for catheter ablation of atrial fibrillation or the bariatric surgeon stating that the patient is being seen pre-operatively for sleeve gastrectomy or gastric bypass.

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.

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

Primary outcomes:
measure: Number of Disease-Specific PROMs Completed
timeFrame: 8 weeks
measure: Number of Post-Procedure PROMs Completed
timeFrame: 5 weeks
measure: Device Syncs
timeFrame: 8 weeks
measure: Electronic Health Record Data Validation
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Yale University
name: Joseph Ross, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Sanket Dhruva, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Nilay Shah, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.