RECRUITING

Discharge Readmission Analysis and Management in Sepsis (DReAMS-2)

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-10-26

Study Completion:2024-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06099756

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age 18 years or older * Admitted to the hospital for 48 hours or greater * Admitted with an index diagnoses of sepsis. We defined sepsis based on the 2018 Centers for Disease Control and Prevention's Adult Sepsis Event (ASE). * The adaptive design will allow the expansion into additional index hospitalization diagnosis (for example, heart failure exacerbation, sickle cell crises, COPD exacerbation, hip fractures, pneumonia, post surgical patients, diabetes mellitus)	* Imminent death or anticipated death during index admission (to include comfort care or hospice) * Patients due to be transferred to another acute care facility * Participants not proficient with written and spoken English. * Participants who do not have a smartphone and valid mobile number to receive text messages. * Participants leaving the hospital against medical advice. * Participants with essential tremor. * Participants deemed non-compliant or not suitable for the study due to cognitive impairment or serious mental health conditions as determined by the Principal Investigator. * Participants unable to independently navigate and operate smartphone applications. * Participants with diminished decision-making capability. * Participants likely to not be available to complete all protocol-required procedures (e.g., Clinical Outcome Assessments) to the best of the subject and investigator's knowledge. * Participants with history or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or study team, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion * Vulnerable Subjects, this study will not enroll children \< 18 years of age, pregnant women, or prisoners.

Inclusion Criteria

Exclusion Criteria

* Age 18 years or older
* Admitted to the hospital for 48 hours or greater
* Admitted with an index diagnoses of sepsis. We defined sepsis based on the 2018 Centers for Disease Control and Prevention's Adult Sepsis Event (ASE).
* The adaptive design will allow the expansion into additional index hospitalization diagnosis (for example, heart failure exacerbation, sickle cell crises, COPD exacerbation, hip fractures, pneumonia, post surgical patients, diabetes mellitus)

* Imminent death or anticipated death during index admission (to include comfort care or hospice)
* Patients due to be transferred to another acute care facility
* Participants not proficient with written and spoken English.
* Participants who do not have a smartphone and valid mobile number to receive text messages.
* Participants leaving the hospital against medical advice.
* Participants with essential tremor.
* Participants deemed non-compliant or not suitable for the study due to cognitive impairment or serious mental health conditions as determined by the Principal Investigator.
* Participants unable to independently navigate and operate smartphone applications.
* Participants with diminished decision-making capability.
* Participants likely to not be available to complete all protocol-required procedures (e.g., Clinical Outcome Assessments) to the best of the subject and investigator's knowledge.
* Participants with history or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or study team, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
* Vulnerable Subjects, this study will not enroll children \< 18 years of age, pregnant women, or prisoners.

Contacts and Locations

Study Contact

Lana Wahid, MD

CONTACT

919-684-5670

lana.wahid@duke.edu

Principal Investigator

Lana Wahid, MD

PRINCIPAL_INVESTIGATOR

Duke University

Study Locations (Sites)

Duke Regional Hospital

Durham, North Carolina, 27704

United States

Duke University Hospital

Durham, North Carolina, 27710

United States

Duke Raleigh Hospital

Raleigh, North Carolina, 27609

United States

Collaborators and Investigators

Sponsor: Measure Labs, Inc.

Lana Wahid, MD, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-26

Study Completion Date2024-10

Study Record Updates

Study Start Date2023-10-26

Study Completion Date2024-10

Terms related to this study

Additional Relevant MeSH Terms

Sepsis