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Post-Market Surveillance With a Novel mHealth Platform

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ClinicalTrials.gov Identifier: NCT03436082
Recruitment Status : Recruiting
First Posted : February 16, 2018
Last Update Posted : March 29, 2018
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.

Study Type : Observational [Patient Registry]
Estimated 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
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : August 31, 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. Enrollment time after a sleeve gastrectomy or gastric bypass [ Time Frame: 8 months ]

    Feasibility of the mobile platform will be assessed from data collected after a sleeve gastrectomy or gastric bypass.

    A research associate (RA) will collect the following data at enrollment: time to set up new Hugo account and enroll patient in study, total enrollment time (from initiation of conversation with research associate to completion of connecting health system portals).


  2. Enrollment time catheter-base atrial fibrilation [ Time Frame: 8 months ]

    Feasibility of the mobile platform will be assessed from data collected after a catheter-base atrial fibrillation.

    A research associate (RA) will collect the following data at enrollment: time to set up new Hugo account and enroll patient in study, total enrollment time (from initiation of conversation with research associate to completion of connecting health system portals).


  3. Patient participation - sleeve gastrectomy or gastric bypass [ Time Frame: 8 months ]

    Feasibility of the mobile platform will be assessed from data collected after a sleeve gastrectomy or gastric bypass.

    The research associate (RA) will then follow-up with study participants in-person on the first post-procedure day (i.e. after catheter ablation of atrial fibrillation or sleeve gastrectomy) to ensure all devices are working properly, and to answer any questions that study participants may have.


  4. Patient dropout - sleeve gastrectomy or gastric bypass [ Time Frame: 8 months ]
    Feasibility of the mobile platform will be assessed from data collected from patients who received a sleeve gastrectomy or gastric bypass. If a patient refuses to participate, the number of people who refused will be noted. If the patient is agreeable, a short questionnaire will be administered to understand the patient's rationale for not participating in the study, to understand potential reasons for non-participation. People who chose not to participate will be asked about basic demographics, if they are willing to answer (age, sex, race/ethnicity, major co-morbidities, insurance status).

  5. Patient dropout - catheter-base atrial fibrilation [ Time Frame: 8 months ]
    Feasibility of the mobile platform will be assessed from data collected from patients who received catheter-base atrial fibrillation. If a patient refuses to participate, the number of people who refused will be noted. If the patient is agreeable, then a short questionnaire will be administered to understand the patient's rationale for not participating in the study, to understand potential reasons for non-participation. The people who chose not to participate will be asked about basic demographics, if they are willing to answer (age, sex, race/ethnicity, major co-morbidities, insurance status).

  6. Completion of patient-reported outcome measure queries [ Time Frame: 8 months ]
    Feasibility of the mobile platform will be assessed from data collected from both, patients who received a sleeve gastrectomy or gastric bypass and patients who received catheter-base atrial fibrillation patients. Patients will receive automatic reminders to complete questionnaires daily for 2 days via email.

  7. Syncing of mobile device data [ Time Frame: 8 months ]

    Feasibility of the mobile platform will be assessed from data collected from both, patients who received a sleeve gastrectomy or gastric bypass and patients who received catheter-base atrial fibrillation patients.

    An attempt to sync the following data from syncable devices for study participants sleeve gastrectomy or gastric bypass patients only:

    • Fitbit (Ambulation, heart rate, and other activity), synced weekly
    • Digital weight scale, synced weekly

    An attempt to sync the following data from syncable devices for study participants:

    • Fitbit (Ambulation, heart rate, and other activity), synced weekly
    • AliveCor (single lead electrocardiographic recording), synced weekly

  8. User satisfaction [ Time Frame: 8 months ]
    Feasibility of the mobile platform will be assessed from data collected from both, patients who received a sleeve gastrectomy or gastric bypass and patients who received catheter-base atrial fibrillation patients. Finally, at the end of the pilot study (i.e. at 8 weeks post-procedure), study participants will be called by the research associate and asked to complete a close-out questionnaire to determine their satisfaction with the process of answering queries and provide the opportunity for them to offer comments and suggestions for improvement. The patient will also be asked at what health systems they received care over the past 8 weeks (including hospitalization, emergency department visit, repeat procedure), to assess if all pertinent data was captured in Hugo.

  9. Patient participation - atrial fibrillation [ Time Frame: 8 months ]

    Feasibility of the mobile platform will be assessed from data collected after a catheter-base atrial fibrillation.

    The research associate (RA) will then follow-up with study participants in-person on the first post-procedure day (i.e. after catheter ablation of atrial fibrillation or sleeve gastrectomy) to ensure all devices are working properly, and to answer any questions that study participants may have.




Information from the National Library of Medicine

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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


Contacts
Contact: Laura Ciaccio, MSc 203-737-7183 laura.ciaccio@yale.edu
Contact: Joseph Ross, MD 203-785-2987 joseph.ross@yale.edu

Locations
United States, Connecticut
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Nilay Shah, PhD    507-266-5130    shah.nilay@mayo.edu   
Sponsors and Collaborators
Yale University
Johnson & Johnson
Food and Drug Administration (FDA)
Mayo Clinic
Investigators
Principal Investigator: Joseph Ross, MD Yale University
Principal Investigator: Sanket Dhruva, MD Yale University
Principal Investigator: Nilay Shah, PhD Mayo Clinic

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03436082     History of Changes
Other Study ID Numbers: 2000021455
First Posted: February 16, 2018    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes