Using the Fitbit for Early Detection of Infection and Reduction of Healthcare Utilization After Discharge in Pediatric Surgical Patients
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The purpose of this study is to analyze Fitbit data to predict infection after surgery for complicated appendicitis and the effect this prediction has on clinician decision making.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 18
Healthy Volunteers: f
View:
• children aged 3-18 years
• must be post-surgical laparoscopic appendectomy for complicated appendicitis (Appendicitis is categorized as complicated if perforation, phlegmon, or abscess was present at surgery.)
Locations
United States
Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
RECRUITING
Chicago
Northwestern University (Feinberg School of Medicine, Shirley Ryan AbilityLab)
NOT_YET_RECRUITING
Chicago
Loyola University Medical Center
NOT_YET_RECRUITING
Maywood
Northwestern Medicine Central DuPage Hospital
RECRUITING
Winfield
Contact Information
Primary
Fizan Abdullah, MD, PhD
fabdullah@luriechildrens.org
312-227-4210
Backup
Arianna Edobor, CRC
idetect@luriechildrens.org
312-227-2118
Time Frame
Start Date: 2025-01-07
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 500
Treatments
No_intervention: Aim 1 - Validation
1a. Development and Internal validation~* analyze Fitbit data (PA, HR, sleep) by applying ML methods to create an infection algorithm indicating onset of infection.~ 1b. External Validation~* Once the ML classifier has been internally validated (using Lurie Children's data only) for its ability to detect the presence or absence of postoperative infection using LOSO cross-validation, where each subject is iteratively held out from the training data and used as a test set. External validation will involve applying this classifier to a newer cohort at LCH and cohorts at Loyola University Hospital and CDH and evaluating its performance.
Experimental: Aim 2 - Implementation of Algorithm
2a. Exploratory \& Inductive analysis~* one transcript will be coded to generate initial themes, using qualitative analytic software 2b. Time to first contact with the healthcare system \& Healthcare use~* Cox regression model will be used to model the time to first contact, adjusted for covariates~* All comparisons between the two groups will be tested using a chi-square test. Cost will be modeled as a continuous variable and is expected to be skewed, as is typical of cost data. We will use a general linear model (GLM) to model cost outcomes.
Related Therapeutic Areas
Sponsors
Collaborators: Loyola University Chicago, Northwestern University, University of Chicago, Central DuPage Hospital
Leads: Ann & Robert H Lurie Children's Hospital of Chicago