Atrial Fibrillation, Gastrectomy
Conditions
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.
Interventions
DEVICEA 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.
Sponsors
Johnson & Johnson
Food and Drug Administration (FDA)
Mayo Clinic
Yale University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Disease-Specific PROMs Completed | 8 weeks | 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. |
| Number of Post-Procedure PROMs Completed | 5 weeks | 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. |
| Device Syncs | 8 weeks | 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. |
| Electronic Health Record Data Validation | 8 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bariatric (Sleeve Gastrectomy/Roux-en-Y) | 30 |
| AF Ablation Atrial Fibrillation Ablation | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not undergo procedure | 1 | 0 |
Baseline characteristics
| Characteristic | AF Ablation | Total | Bariatric |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 14 Participants | 17 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 43 Participants | 27 Participants |
| Age, Continuous | 62.4 Years STANDARD_DEVIATION 10 | 55.2 Years STANDARD_DEVIATION 13.5 | 46.4 Years STANDARD_DEVIATION 12.5 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 30 Participants | 60 Participants | 30 Participants |
| Sex: Female, Male Female | 12 Participants | 35 Participants | 23 Participants |
| Sex: Female, Male Male | 18 Participants | 25 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 30 |
| other Total, other adverse events | 0 / 29 | 0 / 30 |
| serious Total, serious adverse events | 0 / 29 | 0 / 30 |
Outcome results
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.
Time frame: 8 weeks
Population: Assessed for # of device syncs
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bariatric | Device Syncs | Fitbit | 17 # patients who synced at all time points |
| Bariatric | Device Syncs | Disease-Specific (Withings Body Scale/Kardia Mobile) | 11 # patients who synced at all time points |
| AF Ablation | Device Syncs | Fitbit | 14 # patients who synced at all time points |
| AF Ablation | Device Syncs | Disease-Specific (Withings Body Scale/Kardia Mobile) | 15 # patients who synced at all time points |
p-value: 0.85Chi-squared
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.
Time frame: 8 weeks
Population: Assessed for # times encounter date, encounter type, and encounter primary diagnosis matched between the data sharing platform, Hugo, and the patient's EHR
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bariatric | Electronic Health Record Data Validation | Encounter Type | 103 Number of matched records |
| Bariatric | Electronic Health Record Data Validation | Encounter Date | 105 Number of matched records |
| Bariatric | Electronic Health Record Data Validation | Primary Diagnosis | 103 Number of matched records |
| AF Ablation | Electronic Health Record Data Validation | Encounter Date | 110 Number of matched records |
| AF Ablation | Electronic Health Record Data Validation | Encounter Type | 100 Number of matched records |
| AF Ablation | Electronic Health Record Data Validation | Primary Diagnosis | 101 Number of matched records |
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.
Time frame: 8 weeks
Population: Assessed for # disease-specific PROMs completed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bariatric | Number of Disease-Specific PROMs Completed | 64 # PROMs completed |
| AF Ablation | Number of Disease-Specific PROMs Completed | 59 # PROMs completed |
p-value: 0.04Chi-squared
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.
Time frame: 5 weeks
Population: Assessed for # PROMs completed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bariatric | Number of Post-Procedure PROMs Completed | 203 # PROMs completed |
| AF Ablation | Number of Post-Procedure PROMs Completed | 237 # PROMs completed |