AzTrials
AzTrials

Appendectomyi-DETECTNCT06395636

Early Detection of Infection Using the Fitbit in Pediatric Surgical Patients

A study testing Infection-Prediction Algorithm in people with Appendectomy and Appendicitis, run by Ann & Robert H Lurie Children's Hospital of Chicago at 4 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 3 to 18 years
Conditions the study is for
Appendectomy, Appendicitis, Appendicitis Acute
What is being tested?
Infection-Prediction Algorithm
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
4 sitesUnited States
Study dates
7 Jan 2025to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.)

Who cannot join

  • 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)

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Fizan Abdullah, MD, PhD contact

312-227-4210

fabdullah@luriechildrens.org

Arianna Edobor, CRC contact

312-227-2118

idetect@luriechildrens.org

United States4 sites, 4 recruiting
  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611

    Fizan Abdullah, MD, PhD, 312-227-4210, FAbdullah@luriechildrens.org

    Arianna Edobor, BS, 312-227-2118, aedobor@luriechildrens.org

    Recruiting
  • Northwestern University (Feinberg School of Medicine, Shirley Ryan AbilityLab)

    Chicago, Illinois, 60611

    Fizan Abdullah, MD, PhD, 312-227-4210, fabdullah@luriechildrens.org

    Clinical Research Coordinator, 312-227-2118, aedobor@luriechildrens.org

    Not yet recruiting
  • Loyola University Medical Center

    Maywood, Illinois, 60153

    Clinical Research Coordinator, 312-227-2118, aedobor@luriechildrens.org

    Steven A De Jong, MD

    Not yet recruiting
  • Northwestern Medicine Central DuPage Hospital

    Winfield, Illinois, 60190

    Clinical Research Coordinator, 312-227-2118, aedobor@luriechildrens.org

    Guillermo Ares, MD

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Infection-Prediction Algorithm
Keywords
consumer wearables, machine learning, ML, Fitbit, infection, detection, algorithm, prediction
Medical subject headings
Appendicitis, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Infection-Prediction AlgorithmDevice

    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.

Study groups in NCT06395636
Study groupRoleWhat they receive
Aim 1 - ValidationNo intervention1a. 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.
Aim 2 - Implementation of AlgorithmExperimental2a. 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.
Receives: Device: Infection-Prediction Algorithm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Fitbit data metrics will be collected for 30 days starting at date of enrollment.

Secondary outcomes (3)
  1. 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.

    Measured: Daily Diary/Survey Submissions will be asked to be completed daily for 30 days starting day of enrollment.

  2. 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.

    Measured: The diary / survey will require a submission every day for 30 days starting at day of enrollment.

  3. 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.

    Measured: For 30 days starting at day of participant enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2024
  2. Study start7 Jan 2025
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06395636
Sponsor's protocol ID
IRB 2024-6701
Acronym
i-DETECT
Status last verified
May 2026
First submitted
29 Apr 2024
Last updated
13 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Infection-Prediction Algorithm in people with Appendectomy and Appendicitis, run by Ann & Robert H Lurie Children's Hospital of Chicago at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Fizan Abdullah, MD, PhD (312-227-4210, fabdullah@luriechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Trends in Participant Fitbit Data (Physical Activity, Heart Rate, Sleep) during the Recovery Period post Complicated Appendectomy (time frame: Fitbit data metrics will be collected for 30 days starting at date of enrollment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in