Remote Monitoring to Improve Physician Monitoring, Patient Satisfaction, and Predict Readmissions Following Surgery

NCT ID: NCT03800329

Last Updated: 2021-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-07

Study Completion Date

2021-10-26

Brief Summary

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This study is designed to determine the perceived value of continuous remote monitoring to surgeons and surgical patients at Mayo Clinic in Rochester, MN, and determine whether algorithms can be generated to predict risk of readmission following discharge. This initial study will be conducted through the Department of Cardiovascular Surgery.

Detailed Description

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The overall aim of this project is to determine the perceived utility and benefit to use of remote monitoring technology in patients being discharged following cardiac surgery at Mayo Clinic in Rochester, MN. The investigators also aim to determine whether machine learning algorithms can predict readmission following cardiac surgery in these patients, which the investigators believe will benefit patients in future studies.

Conditions

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Remote Monitoring

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Snap40 Monitor

Patients randomly assigned to wear the Snap40 monitor will wear the device for 48 hours following discharge from the hospital.

Group Type ACTIVE_COMPARATOR

Snap40 Monitor

Intervention Type DEVICE

Non-invasive, wearable armband device used to measure change in systolic blood pressure, respiratory rate, heart rate, body temperature, movement, and oxyhemoglobin saturation and streams this information to a cloud-based storage system. Patients will complete a questionnaire.

No Monitor

Patients randomly assigned to not wear the Snap40 monitor will continue with their follow-up surgical care in the ordinary fashion.

Group Type PLACEBO_COMPARATOR

No Monitor

Intervention Type OTHER

Patients will be discharged in the ordinary manner, without the Snap40 monitor. Patients will complete a questionnaire.

Interventions

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Snap40 Monitor

Non-invasive, wearable armband device used to measure change in systolic blood pressure, respiratory rate, heart rate, body temperature, movement, and oxyhemoglobin saturation and streams this information to a cloud-based storage system. Patients will complete a questionnaire.

Intervention Type DEVICE

No Monitor

Patients will be discharged in the ordinary manner, without the Snap40 monitor. Patients will complete a questionnaire.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing isolated coronary artery bypass graft (CABG) surgery
* Must be undergoing the procedure at Mayo Clinic in Rochester, MN
* Must be greater than or equal to 40 years of age

Exclusion Criteria

* Under 40 years of age
* Concomitant additional surgical procedure (e.g., CABG + valve replacement)
* Patients with implantable pacemakers/defibrillators
* Patients that find the device too uncomfortable to wear for 48 hours
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Snap40 Ltd.

UNKNOWN

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Jordan D. Miller, Ph.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jordan D Miller

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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17-008249

Identifier Type: -

Identifier Source: org_study_id