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Early Detection of Infection Using the Fitbit in Pediatric Surgical Patients

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06395636
Acronym
i-DETECT
Enrollment
500
Registered
2024-05-02
Start date
2025-01-07
Completion date
2027-06-30
Last updated
2026-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appendectomy, Appendicitis, Appendicitis Acute

Keywords

consumer wearables, machine learning, ML, Fitbit, infection, detection, algorithm, prediction

Brief 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.

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.

Interventions

DEVICEInfection-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.

Sponsors

Ann & Robert H Lurie Children's Hospital of Chicago
Lead SponsorOTHER
Northwestern University
CollaboratorOTHER
Central DuPage Hospital
CollaboratorOTHER
University of Chicago
CollaboratorOTHER
Loyola University Chicago
CollaboratorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Trends in Participant Fitbit Data (Physical Activity, Heart Rate, Sleep) during the Recovery Period post Complicated AppendectomyFitbit data metrics will be collected for 30 days starting at date of enrollment.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.

Secondary

MeasureTime frameDescription
Number of Reported Symptoms and Complications during RecoveryDaily Diary/Survey Submissions will be asked to be completed daily for 30 days starting day of enrollment.Participants \& Parents/Guardians will report any symptoms or complications that occur during the recovery period via a daily diary/survey.
Healthcare Utilizations during Recovery PeriodThe diary / survey will require a submission every day for 30 days starting at day of enrollment.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.
Change in Clinician Decision Making from Algorithm ResultsFor 30 days starting at day of participant enrollmentClinicians of participants (Aim 2) will be asked if the results from the infection prediction algorithm had any impact on their clinical care decisions.

Countries

United States

Contacts

CONTACTFizan Abdullah, MD, PhD
fabdullah@luriechildrens.org312-227-4210
CONTACTArianna Edobor, CRC
idetect@luriechildrens.org312-227-2118
PRINCIPAL_INVESTIGATORFizan Abdullah, MD, PhD

Ann & Robert H Lurie Children's Hospital of Chicago

PRINCIPAL_INVESTIGATORHassan Ghomrawi, PhD, MPH

University of Alabama at Birmingham

PRINCIPAL_INVESTIGATORArun Jayaraman, PT, PhD

Shirley Ryan AbilityLab

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 14, 2026