Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT06099756
Status:
UNKNOWN
Last Update Posted:
2023-11-07
First Post:
2023-10-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Discharge Readmission Analysis and Management in Sepsis (DReAMS-2)
Sponsor:
Measure Labs, Inc.
Organization:
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:
UNKNOWN
Status Verified Date:
2023-11
Last Known Status:
RECRUITING
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 patient's 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 participant's 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 participant's 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 don't 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 participant's 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 participant's 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 don't respond, after day 30, participant will no longer receive text messages.
Study Oversight
Has Oversight DMC:
True
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?: