An observational study in Gastrectomy and Atrial Fibrillation, sponsored by Yale University. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-19.
Sponsored by Yale University · Observational
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
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.
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.
Exclusion Criteria:
Healthy patients
Patients who refuse participation
Patients that have undergone sleeve gastrectomy or gastric bypass will pilot test the use of the patient-led, smartphone based, mhHealth platform HUGO.
Device: 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.
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.
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.
Time frame: 8 weeks
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.
Time frame: 5 weeks
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.
Time frame: 8 weeks
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.
Time frame: 8 weeks
| Milestone | Bariatric | AF Ablation |
|---|---|---|
| Started | 30 | 30 |
| Completed | 29 | 30 |
| Not completed | 1 | 0 |
| Withdrew: Did not undergo procedure | 1 | 0 |
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.
| # PROMs completed | Bariatric | AF Ablation |
|---|---|---|
| Number of Disease-Specific PROMs Completed | 64 | 59 |
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.
| # PROMs completed | Bariatric | AF Ablation |
|---|---|---|
| Number of Post-Procedure PROMs Completed | 203 | 237 |
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.
| # patients who synced at all time points | Bariatric | AF Ablation |
|---|---|---|
| Fitbit | 17 | 14 |
| Disease-Specific (Withings Body Scale/Kardia Mobile) | 11 | 15 |
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 matched records | Bariatric | AF Ablation |
|---|---|---|
| Encounter Date | 105 | 110 |
| Encounter Type | 103 | 100 |
| Primary Diagnosis | 103 | 101 |
Collected over 8 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bariatric | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) |
| AF Ablation | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
We enrolled a convenience sample of patients who were planning on undergoing either bariatric surgery (sleeve gastrectomy and gastric bypass) or catheter-based atrial fibrillation ablation at Yale-New Haven Hospital (YNHH) or the Mayo Clinic. 15 patients were enrolled for each procedure at each site, for a total of 60 patients.
| Age, Categorical(Participants) | Bariatric | AF Ablation | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 27 | 16 | 43 |
| >=65 years | 3 | 14 | 17 |
| Age, Continuous(Years) | Bariatric | AF Ablation | Total |
|---|---|---|---|
| Mean | 46.4 ± 12.5 | 62.4 ± 10 | 55.2 ± 13.5 |
| Sex: Female, Male(Participants) | Bariatric | AF Ablation | Total |
|---|---|---|---|
| Female | 23 | 12 | 35 |
| Male | 7 | 18 | 25 |
| Race and Ethnicity Not Collected(Participants) | Bariatric | AF Ablation | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Bariatric | AF Ablation | Total |
|---|---|---|---|
| United States | 30 | 30 | 60 |
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Yale University