Remote MonitoringNCT03800329
Remote Monitoring to Improve Physician Monitoring, Patient Satisfaction, and Predict Readmissions Following Surgery
A study testing Snap40 Monitor and No Monitor in people with Remote Monitoring, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Remote Monitoring
- What is being tested?
- Snap40 Monitor and No Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2018to 26 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Use of Remote Monitoring to Improve Physician Monitoring, Patient Satisfaction, and Predict Readmissions Following Cardiac Surgery
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.
Read the detailed description
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
- Remote Monitoring
- Being tested
- Snap40 Monitor, No Monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Snap40 MonitorDevice
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 MonitorOther
Patients will be discharged in the ordinary manner, without the Snap40 monitor. Patients will complete a questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Snap40 Monitor | Active comparator | Patients randomly assigned to wear the Snap40 monitor will wear the device for 48 hours following discharge from the hospital. Receives: 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. Receives: Other: No Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 hours
Secondary outcomes (1)
Patient satisfaction in the use of remote monitoring technology.
Patient satisfaction survey measures the utility and benefit to the use of remote monitoring technology in patients being discharged following cardiac surgery at Mayo Clinic in Rochester, MN.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start7 Mar 2018
- Primary completion26 Oct 2021
- Study completion26 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Remote MonitoringStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Snap40 Ltd.
- Responsible party
- Principal investigator, Jordan D. Miller, Ph.D., Mayo Clinic
- Investigators
- Jordan D Miller, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03800329
- Sponsor's protocol ID
- 17-008249
- Status last verified
- Nov 2021
- First submitted
- 14 Aug 2018
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Remote Monitoring to Improve Physician Monitoring, Patient Satisfaction, and Predict Readmissions Following Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03800329
- Acronym / sponsor ID
- 17-008249
- Conditions
- Remote Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Snap40 Ltd.
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- 26 Oct 2021 (actual)
- Study completion
- 26 Oct 2021 (actual)
- First posted
- 11 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Snap40 Monitor | Active comparator | Device: Snap40 MonitorPatients randomly assigned to wear the Snap40 monitor will wear the device for 48 hours following discharge from the hospital. |
| No Monitor | Placebo comparator | Other: No MonitorPatients randomly assigned to not wear the Snap40 monitor will continue with their follow-up surgical care in the ordinary fashion. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Snap40 MonitorNon-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. | Device | Snap40 Monitor |
| No MonitorPatients will be discharged in the ordinary manner, without the Snap40 monitor. Patients will complete a questionnaire. | Other | No Monitor |
Primary outcome
Physician satisfaction in the use of remote monitoring technology.
Time frame: 48 hours
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.
1 secondary outcome
Patient satisfaction in the use of remote monitoring technology.
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Jordan D Miller principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Snap40 Monitor and No Monitor in people with Remote Monitoring, run by Mayo Clinic at 1 site 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 3 inclusion and 4 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 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Physician satisfaction in the use of remote monitoring technology. (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2021.