Early Detection of Infection Using the Fitbit in Pediatric Surgical Patients (i-DETECT)

Using the Fitbit for Early Detection of Infection and Reduction of Healthcare Utilization After Discharge in Pediatric Surgical Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Appendicitis; Appendicitis Acute; Appendectomy
• Intervention / Treatment: Device: Infection-Prediction Algorithm

Detailed Description

We propose to investigate the use of objective near-real time data from the Fitbit consumer wearable device (CWD) for early detection of postoperative infection in children after appendectomy for complicated appendicitis, and its influence on clinician decision-making, time to first contact with the healthcare system, and postoperative healthcare use. SSI is usually associated with increased heart rate (HR) and reduced physical activity (PA), and sleep disturbances due to discomfort, pain, and fever.13-15 To help monitor patients post-discharge, CDWs can be used to detect physiologic changes, prompting early management.16,17 CWDs generate continuous, valid HR data comparable to clinical-grade HR monitor data for children, as well as objective PA and sleep data, which are good indicators of recovery.18-21 CWDs, then transmit these data in near-real time to a cloud-based system potentially accessible to a clinician. Although health systems have incorporated CWD data into electronic health records,16,17 use in post-discharge monitoring of pediatric surgery patients has been limited18 since it is difficult to monitor and interpret the large volumes of data generated by CWD in clinically meaningful ways.18 Machine learning (ML) methods, which reduce CWD data into clinically meaningful signals are needed.22 Since these algorithms are based on data from multiple CWD sensors, they are more accurate than threshold-based alerts.

We collected Fitbit data on 160 pediatric appendectomy patients21,23,24 and showed slower normative recovery PA trajectories in children with complicated versus simple appendicitis, and deviations from normative PA trajectory (decreased PA) before parents sought healthcare for complications.20 We then applied ML methods to Fitbit data of 80 post appendectomy patients with complicated appendicitis to predict infection. The preliminary algorithm predicted 90% of infections, 2 days before parental report. In parallel, we developed a proof-of-concept dashboard that delivers Fitbit data daily and on-demand in near real-time to clinicians. Using the dashboard, clinicians evaluated hypothetical post-discharge pediatric appendectomy scenarios with and without Fitbit dashboard data. Availability of Fitbit data (even without ML) substantially changed clinicians' likelihood of recommending ED care. While our early results are promising, a larger study is needed to definitively elucidate the association of changes in Fitbit data with postoperative infection and to assess the effect of Fitbit data on clinician decision-making and healthcare use. We propose to develop a ML algorithm for postoperative infection using Fitbit data of children 3-18 years old undergoing a appendectomy for complicated appendicitis at the Ann and Robert H. Lurie Children's Hospital of Chicago (LCH), a tertiary care children's hospital and two affiliated hospitals Loyola University Medical Center, a university hospital), and Central DuPage Hospital (CDH), a community hospital. Our two aims are:

Aim 1: Develop and externally validate an ML algorithm for postoperative infection. In addition to the 80 patients already recruited in our preliminary study, we will prospectively recruit 170 patients for a total of 250 from LCH for development and internal validation. We will then externally validate our infection ML algorithm using data on 122 appendectomy patients from LCH and its two affiliates.

Aim 2: Conduct a pre-post study to determine the effect of near real-time availability of the infection alert from Fitbit on clinical decision-making, time to first contact with the healthcare system, and healthcare utilization. We will place a Fitbit on 94 children after appendectomy recruited from LCH and its two affiliates, and send their surgeons daily reports of their recovery progress and near real-time, ML-based, clinical alerts of infection. In Aim 2a, we will use critical incident technique to qualitatively assess surgeons' decision-making after receiving Fitbit alerts and daily reports. In Aim 2b, we will compare median time to first contact with the healthcare system, healthcare use patterns (e.g., ED visits) and costs pre and post receiving alerts and daily reports.

Impact: This study is well aligned with NINR's priority to advance symptoms science. Developing CWD alerts to detect infection and evaluating their effect on clinical care have the potential to transform pediatric surgical care and pave the way for wide uptake of CWD. By proactively reaching to patients, this technology also has the potential to reduce existing disparities in seeking care.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fizan Abdullah, MD, PhD; Phone Number: 312-227-4210; Email: fabdullah@luriechildrens.org
• Study Contact Backup: Name: Arianna Edobor, CRC; Phone Number: 312-227-2118; Email: idetect@luriechildrens.org

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Ann & Robert H. Lurie Children's Hospital of Chicago
      • Contact: Fizan Abdullah, MD, PhD; Phone Number: 312-227-4210; Email: fabdullah@luriechildrens.org
      • Contact: Arianna Edobor, BS; Phone Number: 312-227-2118; Email: aedobor@luriechildrens.org
      • Principal Investigator: Fizan Abdullah, MD, PhD
    • Chicago, Illinois, United States, 60611
      • Not yet recruiting
      • Northwestern University (Feinberg School of Medicine, Shirley Ryan AbilityLab)
      • Contact: Fizan Abdullah, MD, PhD; Phone Number: 312-227-4210; Email: fabdullah@luriechildrens.org
      • Contact: Clinical Research Coordinator; Phone Number: 312-227-2118; Email: aedobor@luriechildrens.org
      • Principal Investigator: Fizan Abdullah, MD, PhD
    • Maywood, Illinois, United States, 60153
      • Not yet recruiting
      • Loyola University Medical Center
      • Contact: Clinical Research Coordinator; Phone Number: 312-227-2118; Email: aedobor@luriechildrens.org
      • Sub-Investigator: Steven A De Jong, MD
    • Winfield, Illinois, United States, 60190
      • Recruiting
      • Northwestern Medicine Central DuPage Hospital
      • Contact: Clinical Research Coordinator; Phone Number: 312-227-2118; Email: aedobor@luriechildrens.org
      • Sub-Investigator: Guillermo Ares, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.)

Exclusion Criteria:

• children who are non-ambulatory or have any pre-existing mobility limitations
• children who have a doctor-ordered physical activity limit >48 hours post-surgery
• children who have a comorbidity which will impact a patient's recovery
• children and/or parents who do not speak English or Spanish (Translation services beyond Spanish will not be available at this time)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Infection-Prediction Algorithm; This machine learning algorithm will be developed(Aim1a) and validated(Aim 1b) using the participant Fitbit data and survey results collected during Aim 1. In Aim 2 the algorithm will be used in real time to predict postoperative infection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trends in Participant Fitbit Data (Physical Activity, Heart Rate, Sleep) during the Recovery Period post Complicated Appendectomy	Participant Fitbit data metrics (particularly PA, HR, Sleep) will be extracted from the app and analyzed using Machine Learning methods to eventually develop an algorithm to predict infection during the postoperative recovery period.	Fitbit data metrics will be collected for 30 days starting at date of enrollment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Reported Symptoms and Complications during Recovery	Participants & Parents/Guardians will report any symptoms or complications that occur during the recovery period via a daily diary/survey.	Daily Diary/Survey Submissions will be asked to be completed daily for 30 days starting day of enrollment.
Healthcare Utilizations during Recovery Period	The daily diary/survey will also ask Parents / Guardians of any trips to the ER, readmissions, or hospital visits relating to the participant's appendectomy.	The diary / survey will require a submission every day for 30 days starting at day of enrollment.
Change in Clinician Decision Making from Algorithm Results	Clinicians of participants (Aim 2) will be asked if the results from the infection prediction algorithm had any impact on their clinical care decisions.	For 30 days starting at day of participant enrollment

Collaborators and Investigators

• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
• Collaborators: Northwestern University; University of Chicago; Loyola University Chicago; Central DuPage Hospital
• Investigators: Principal Investigator: Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab; Principal Investigator: Fizan Abdullah, MD, PhD, Ann & Robert H Lurie Children's Hospital of Chicago; Principal Investigator: Hassan Ghomrawi, PhD, MPH, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: April 29, 2024
• First Submitted That Met QC Criteria: April 29, 2024
• First Posted (Actual): May 2, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: machine learning; infection; algorithm; prediction; Fitbit; detection; ML; consumer wearables
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Cecal Diseases; Intraabdominal Infections; Infections; Appendicitis
• Other Study ID Numbers: IRB 2024-6701

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes