Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06099756
Status:
RECRUITING
Last Update Posted:
2023-11-07
First Post:
2023-10-19
Brief Title:
Discharge Readmission Analysis and Management in Sepsis DReAMS-2
Sponsor:
Measure Labs Inc
Organization:
Measure Labs Inc
Study Overview
Official Title:
Discharge Readmission Analysis and Management in Sepsis DReAMS-2 Augmenting Readmission Risk Models With Smartphone PPG Signals and Deep Learning an Adaptive Platform
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an adaptive platform This study is being done to collect information that will help us identify trends in patients with sepsis and other health conditions being readmitted into hospitals within 30 days of being discharged This information will be used to create a computer tool that will help predict a patients risk of being readmitted into the hospital after being discharged
Participants will allow the study team to follow their health after they are discharged by taking their temperature once a day and placing their index finger over their smartphone camera when prompted by a text message Participants will receive the text messages twice a day When the participant receives the text message they will click on the link and follow the instructions Instructions include how to long to keep your finger on your phone camera and how to report your daily temperature Additional questions will also be asked After 30 days the text messages will stop and participation will be complete
Participants will allow the study team to follow their health after they are discharged by taking their temperature once a day and placing their index finger over their smartphone camera when prompted by a text message Participants will receive the text messages twice a day When the participant receives the text message they will click on the link and follow the instructions Instructions include how to long to keep your finger on your phone camera and how to report your daily temperature Additional questions will also be asked After 30 days the text messages will stop and participation will be complete
Detailed Description:
Patients admitted into the hospital for sepsis and other health conditions see inclusion criteria and planning to be discharged within 72 hours will be approached for this study Once patient agrees to participate in this study the following will occur
The study team member will guide the participant to open the study smartphone app on their phone
The app will provide a tutorial on how to take a measurement after which the participant will complete their first measurement The Duke research team member will assist the participant to ensure it is taken correctly The measurement involves taking a video of the participants fingertip using the app by placing their finger on the smartphone camera and holding their hand flat on a table The video frames are immediately processed in real-time to extract the blood flow signal The app automatically uploads the blood flow signal to the Measure Labs cloud backend
Once the patient has completed their first measurement they will be considered enrolled in the study
Study team will measure participants vital signs heart rate respiratory rate blood pressure temperature and oxygen saturation after they have been enrolled into the study
A digital thermometer will be sent home with the participants on day of discharge The app will provide an input for the participant to enter their daily temperature
Throughout the study the participant will be expected to place their fingertip on their smartphone camera twice a day and take their temperature once a day Participants will receive two text messages with a link to enter their temperature scan their fingertip with their camera and answer some questions about their current health status Participation will occur from day of consent to 30 days after patient was enrolled During the final week of the study the patient will be asked if they would like to continue receiving text messages for an additional 60 days If they decline or dont respond after day 30 participant will no longer receive text messages
The study team member will guide the participant to open the study smartphone app on their phone
The app will provide a tutorial on how to take a measurement after which the participant will complete their first measurement The Duke research team member will assist the participant to ensure it is taken correctly The measurement involves taking a video of the participants fingertip using the app by placing their finger on the smartphone camera and holding their hand flat on a table The video frames are immediately processed in real-time to extract the blood flow signal The app automatically uploads the blood flow signal to the Measure Labs cloud backend
Once the patient has completed their first measurement they will be considered enrolled in the study
Study team will measure participants vital signs heart rate respiratory rate blood pressure temperature and oxygen saturation after they have been enrolled into the study
A digital thermometer will be sent home with the participants on day of discharge The app will provide an input for the participant to enter their daily temperature
Throughout the study the participant will be expected to place their fingertip on their smartphone camera twice a day and take their temperature once a day Participants will receive two text messages with a link to enter their temperature scan their fingertip with their camera and answer some questions about their current health status Participation will occur from day of consent to 30 days after patient was enrolled During the final week of the study the patient will be asked if they would like to continue receiving text messages for an additional 60 days If they decline or dont respond after day 30 participant will no longer receive text messages
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None