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Post-Market Surveillance With a Novel mHealth Platform

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03436082
Recruitment Status : Completed
First Posted : February 19, 2018
Results First Posted : March 19, 2021
Last Update Posted : March 19, 2021
Sponsor:
Collaborators:
Johnson & Johnson
Food and Drug Administration (FDA)
Mayo Clinic
Information provided by (Responsible Party):
Yale University

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

Condition or disease Intervention/treatment
Gastrectomy Atrial Fibrillation Device: A mobile health platform

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 8 Weeks
Official Title: Post-Market Surveillance With a Novel mHealth Platform
Actual Study Start Date : January 26, 2018
Actual Primary Completion Date : December 25, 2018
Actual Study Completion Date : December 25, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  1. Number of Disease-Specific PROMs Completed [ Time Frame: 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.

  2. Number of Post-Procedure PROMs Completed [ Time Frame: 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.

  3. Device Syncs [ Time Frame: 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.

  4. Electronic Health Record Data Validation [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03436082


Locations
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United States, Connecticut
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Yale University
Johnson & Johnson
Food and Drug Administration (FDA)
Mayo Clinic
Investigators
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Principal Investigator: Joseph Ross, MD Yale University
Principal Investigator: Sanket Dhruva, MD Yale University
Principal Investigator: Nilay Shah, PhD Mayo Clinic
  Study Documents (Full-Text)

Documents provided by Yale University:
Study Protocol  [PDF] September 24, 2018
No Statistical Analysis Plan (SAP) exists for this study.

Additional Information:

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03436082    
Other Study ID Numbers: 2000021455
First Posted: February 19, 2018    Key Record Dates
Results First Posted: March 19, 2021
Last Update Posted: March 19, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes