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.
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.
United States4 sites, 4 recruiting
- 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
- Not yet 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
- Recruiting
Northwestern Medicine Central DuPage Hospital
Winfield, Illinois, 60190
Clinical Research Coordinator, 312-227-2118, aedobor@luriechildrens.org
Guillermo Ares, MD
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.
- Conditions
- Appendectomy, Appendicitis, Appendicitis Acute
- 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 group | Role | What they receive |
|---|---|---|
| Aim 1 - Validation | No intervention | 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. |
| Aim 2 - Implementation of Algorithm | Experimental | 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. Receives: Device: Infection-Prediction Algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
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.
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.
- First posted2 May 2024
- Study start7 Jan 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppendectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University, Central DuPage Hospital, University of Chicago, Loyola University Chicago
- Responsible party
- Principal investigator, Fizan Abdullah, MD, PhD, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Fizan Abdullah, MD, PhD, Principal investigator, Ann & Robert H Lurie Children's Hospital of ChicagoHassan Ghomrawi, PhD, MPH, Principal investigator, University of Alabama at BirminghamArun Jayaraman, PT, PhD, Principal investigator, Shirley Ryan AbilityLab
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
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using the Fitbit for Early Detection of Infection and Reduction of Healthcare Utilization After Discharge in Pediatric Surgical Patients
- ClinicalTrials.gov ID
- NCT06395636
- Acronym / sponsor ID
- i-DETECT / IRB 2024-6701
- Conditions
- Appendectomy, Appendicitis, Appendicitis Acute
- Keywords
- consumer wearables, machine learning, ML, Fitbit, infection, detection, algorithm, prediction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Collaborators
- Northwestern University, Central DuPage Hospital, University of Chicago, Loyola University Chicago
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 2 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aim 1 - Validation | No intervention | –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. |
| Aim 2 - Implementation of Algorithm | Experimental | Device: Infection-Prediction Algorithm2a. 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. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infection-Prediction AlgorithmThis 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. | Device | Aim 2 - Implementation of Algorithm |
Primary outcome
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.
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.
3 secondary outcomes
Number of Reported Symptoms and Complications during Recovery
Time frame: Daily Diary/Survey Submissions will be asked to be completed daily for 30 days starting day of enrollment.
Healthcare Utilizations during Recovery Period
Time frame: 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
Time frame: For 30 days starting at day of participant enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fizan Abdullah, MD, PhD principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
Hassan Ghomrawi, PhD, MPH principal investigator
University of Alabama at Birmingham
Arun Jayaraman, PT, PhD principal investigator
Shirley Ryan AbilityLab
4 sites in 1 country: see every site and its status.
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.