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| Name | Class |
|---|---|
| Johnson & Johnson | INDUSTRY |
| Food and Drug Administration (FDA) | FED |
| Mayo Clinic | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A mobile health platform | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Healthy patients
Patients who refuse participation
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Ross, MD | Yale University | Principal Investigator |
| Sanket Dhruva, MD | Yale University | Principal Investigator |
| Nilay Shah, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital | New Haven | Connecticut | 06510 | United States | ||
| Mayo Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32352038 | Result | 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. | |
| 35265911 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bariatric | (Sleeve Gastrectomy/Roux-en-Y) |
| FG001 | AF Ablation | Atrial Fibrillation Ablation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Bariatric | (Sleeve Gastrectomy/Roux-en-Y) |
| BG001 | AF Ablation | Atrial Fibrillation Ablation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Assessed for # disease-specific PROMs completed | Posted | Number | # PROMs completed | 8 weeks | # PROMs distributed | # PROMs distributed |
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bariatric | (Sleeve Gastrectomy/Roux-en-Y) | 0 |
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Enrolled a small number of patients (60) for a relatively short follow-up duration (8 weeks); EHR data for 5 patients were not observable in Hugo due to sync failure after portals were locked out from multiple incorrect password entries or an EHR upgrade; Stipends were provided to cover time and effort involved with study enrollment and participation and free personal digital devices, both of which may have enhanced engagement over the follow-up period; Did not examine quality of data obtained
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph Ross, MD, MHS | Yale School of Medicine | 203-785-2987 | joseph.ross@yale.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 24, 2018 | Mar 18, 2021 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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|
| Rochester |
| Minnesota |
| 55905 |
| United States |
| 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. |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Atrial Fibrillation Ablation |
|
|
|
| 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. | Assessed for # PROMs completed | Posted | Number | # PROMs completed | 5 weeks | # PROMs distributed | # PROMs distributed |
|
|
|
| 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. | Assessed for # of device syncs | Posted | Number | # patients who synced at all time points | 8 weeks |
|
|
|
|
| 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. | Assessed for # times encounter date, encounter type, and encounter primary diagnosis matched between the data sharing platform, Hugo, and the patient's EHR | Posted | Number | Number of matched records | 8 weeks | Patient Records | Patient Records |
|
|
|
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | AF Ablation | Atrial Fibrillation Ablation | 0 | 30 | 0 | 30 | 0 | 30 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Primary Diagnosis |
|