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

NCT03800329 | Completed

• 1 other identifier: 17-008249
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Remote Monitoring

Outcome Measures

Primary Outcomes (1)

• Physician satisfaction in the use of remote monitoring technology.

  Physician satisfaction survey measure the utility and benefit to the use of remote monitoring technology in patients being discharged following cardiac surgery at Mayo Clinic in Rochester, MN.

  48 hours

Secondary Outcomes (1)

• Patient satisfaction in the use of remote monitoring technology.

  48 hours

Other Outcomes (1)

• Algorithms useful in prediction of readmission following cardiac surgery

  48 hours

Study Arms (2)

Snap40 Monitor

ACTIVE COMPARATOR

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

Device: Snap40 Monitor

No Monitor

PLACEBO COMPARATOR

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

Other: No Monitor

Interventions

Snap40 Monitor 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.

Snap40 Monitor

No Monitor OTHER

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

No Monitor

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Snap40 Ltd.: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Jordan D Miller

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: January 11, 2019
• Study Start: March 7, 2018
• Primary Completion: October 26, 2021
• Study Completion: October 26, 2021
• Last Updated: November 3, 2021

Record last verified: 2021-11

Locations

US (1)