GastrectomyNCT03436082
Post-Market Surveillance With a Novel mHealth Platform
An observational study of Gastrectomy and Atrial Fibrillation, run by Yale University at 2 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrectomy, Atrial Fibrillation
- What is being tested?
- A mobile health platform
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Jan 2018to 25 Dec 2018
- How long will I take part?
- 8 Weeks
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Healthy patients
- Patients who refuse participation
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Yale New Haven Hospital
New Haven, Connecticut, 06510
Mayo Clinic
Rochester, Minnesota, 55905
About this study
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
Read the 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.
- Conditions
- Gastrectomy, Atrial Fibrillation
- Being tested
- A mobile health platform
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A mobile health platformDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: A mobile health platform | |
| 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. Receives: Device: A mobile health platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start26 Jan 2018
- Primary completion25 Dec 2018
- Study completion25 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GastrectomyStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 8 Weeks
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson, Food and Drug Administration (FDA), Mayo Clinic
- Responsible party
- Sponsor
- Investigators
- Joseph Ross, MD, Principal investigator, Yale UniversitySanket Dhruva, MD, Principal investigator, Yale UniversityNilay Shah, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03436082
- Sponsor's protocol ID
- 2000021455
- Status last verified
- Mar 2021
- First submitted
- 31 Jan 2018
- Last updated
- 19 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32352038Bartlett 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.
PubMed 35265911
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Surveillance With a Novel mHealth Platform
- ClinicalTrials.gov ID
- NCT03436082
- Acronym / sponsor ID
- 2000021455
- Conditions
- Gastrectomy, Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Johnson & Johnson, Food and Drug Administration (FDA), Mayo Clinic
- Study start
- 26 Jan 2018 (actual)
- Primary completion
- 25 Dec 2018 (actual)
- Study completion
- 25 Dec 2018 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Posted 19 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Data from a mHealth platform after bariatric surgery | – | Device: A mobile health platformPatients 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 | – | Device: A mobile health platformPatients that have undergone a catheter-based atrial fibrillation ablation will pilot test the use of the patient-led, smartphone based, mobile health platform HUGO. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Healthy patients
- Patients who refuse participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A mobile health platformPatients 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. | Device | Data from a mHealth platform after bariatric surgery, Data from a mobile health platform after atrial fibrillation |
Primary outcome
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.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32352038Dhruva 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.
- Derived from this study: PubMed 35265911Bartlett 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.
- Individual participant dataSharing planned: No
Related trials for Gastrectomy
RecruitingObservational study
Two-Year Weight Loss With GLP-1 Medications Compared With Sleeve Gastrectomy in Adults With Obesity
Obesity & Overweight
Not yet recruitingObservational study
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
Recruiting
Remimazolam for Reducing Postoperative Delirium in Elderly Patients Undergoing Laparoscopic Gastrectomy
Gastric Cancer, Postoperative Delirium
Not yet recruitingPhase 2
D2 Gastrectomy With or Without Para-Aortic Lymph Node Dissection After Chemoimmunotherapy for Gastric Cancer
Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
Recruiting
TEAS Timing for Gastrectomy Recovery (TEAS-TIME Trial)
Gastric Cancer (GC), Stomach Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Ross, MD principal investigator
Yale University
Sanket Dhruva, MD principal investigator
Yale University
Nilay Shah, PhD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrectomy and Atrial Fibrillation, run by Yale University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Disease-Specific PROMs Completed (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03436082, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2021.