Recruiting

Observational Study

Sponsor:

Measure Labs, Inc.

Code:

NCT06099756

Conditions

Sepsis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Sepsis

Study ID

NCT06099756

Start date

Oct 26, 2023

Status verified date

Nov, 2023

Completion date

Oct, 2024

Anticipated

Primary completion date

Oct, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion 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).

\[1\] A subject must have an order for blood cultures, at least 4 qualifying antimicrobial days AND Evidence of at least 1 end organ dysfunction (new vasopressors, initiation of mechanical ventilation, doubling of serum creatinine (or GFR reduction by 50%), total bilirubin ≥ 2.0 mg/dl, an increase by 100% from baseline, platelet count < 100 cells/ul, and lactate ≥ 2.0.
  • 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)

Exclusion Criteria:

  • 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.

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Unplanned readmissions [ Time Frame: From discharge date to 30, 60, 90 days post discharge ]

Central Contacts and Locations

Central contacts

Lana Wahid, MD

919-684-5670lana.wahid@duke.edu

Locations

Duke Regional Hospital

Recruiting

Durham, North Carolina, United States, 27704

Contacts

Lana Wahid, MD

lana.wahid@duke.edu

Parisa Farahani, MD, MPH

919-684-5670parisa.farahani@duke.edu

Duke University Hospital

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Lana Wahid, MD

lana.wahid@duke.edu

Parisa Farahani, MD, MPH

919-684-5670parisa.farahani@duke.edu

Duke Raleigh Hospital

Recruiting

Raleigh, North Carolina, United States, 27609

Contacts

Lana Wahid, MD

lana.wahid@duke.edu

Parisa Farahani, MD, MPH

919-684-5670parisa.farahani@duke.edu

More Information

Sponsor

Measure Labs, Inc.

Last update posted

Nov 7, 2023

Last verified

Nov, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Measure Labs, Inc. on 2023-11-07.