N/A
Completed N=60
Post-Market Surveillance With a Novel mHealth Platform
Gastrectomy · Atrial Fibrillation
Source: ClinicalTrials.gov NCT03436082 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcomePrimary: Number of Disease-Specific PROMs Completed — 64; 59 # PROMs completed — p=0.04
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Disease-Specific PROMs Completed |
64; 59 | 0.04 sig |
| PRIMARY Number of Post-Procedure PROMs Completed |
203; 237 | — |
| PRIMARY Device Syncs |
17; 14; 11; 15 | 0.85 |
| PRIMARY Electronic Health Record Data Validation |
105; 110; 103; 100; 103; 101 | — |
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
Data sourced from ClinicalTrials.gov (NCT03436082). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.