Actively Recruiting

Phase Not Applicable
Age: 3Years - 18Years
All Genders
ID06395636

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

Led by Ann & Robert H Lurie Children's Hospital of Chicago · Updated on 2026-05-13

500

Participants Needed

4

Research Sites

N/A

Total Duration

On this page

Sponsors

A

Ann & Robert H Lurie Children's Hospital of Chicago

Lead Sponsor

N

Northwestern University

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to analyze data from the Fitbit wearable device to predict infections after surgery in children with complicated appendicitis. The study focuses on how this prediction affects clinical decision-making, time to first contact with healthcare, and postoperative healthcare use. The study involves children aged 3 to 18 who have undergone laparoscopic appendectomy for complicated appendicitis, with the goal of improving early infection detection and patient care. Participants will wear Fitbit devices that collect heart rate, physical activity, and sleep data in near-real time. Machine learning methods will be applied to this data to develop and validate an algorithm that detects postoperative infection. The study has two main parts: first, developing and validating the infection prediction algorithm using Fitbit data; second, assessing how access to real-time infection alerts influences clinicians’ decisions and healthcare use. This includes daily reports and alerts sent to surgeons for patients in the implementation phase. Throughout the study, Fitbit data and daily symptom diaries will be collected for 30 days from enrollment to monitor recovery. Researchers will analyze changes in physical activity, heart rate, sleep patterns, symptom reports, healthcare visits, and clinician decision-making. The study includes surveys and qualitative assessments to understand the impact of Fitbit data on care. Participants are monitored for postoperative infection and healthcare utilization during this period, supporting early detection and improved management.

CONDITIONS

Brief Title

Early Detection of Infection Using the Fitbit in Pediatric Surgical Patients

Who Can Participate

Age: 3Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 3 to 18 years
  • Must have had laparoscopic appendectomy for complicated appendicitis (with perforation, phlegmon, or abscess present at surgery)
Not Eligible

You will not qualify if you...

  • Children who are non-ambulatory or have pre-existing mobility limitations
  • Children with a doctor-ordered physical activity restriction lasting more than 48 hours post-surgery
  • Children with comorbidities that may affect recovery
  • Children or parents who do not speak English or Spanish (translation services beyond Spanish not available)

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Monitoring

Duration - 30 days

Participants wear a Fitbit device after surgery to collect physical activity, heart rate, and sleep data. This data is used to detect early signs of infection and to evaluate recovery progress.

Daily data collection via Fitbit device; daily diary/survey submissions for 30 days

Trial Site Locations

Total: 4 locations

1

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States, 60611

Actively Recruiting

2

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

Chicago, Illinois, United States, 60611

Not Yet Recruiting

3

Loyola University Medical Center

Maywood, Illinois, United States, 60153

Not Yet Recruiting

4

Northwestern Medicine Central DuPage Hospital

Winfield, Illinois, United States, 60190

Actively Recruiting

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Research Team

F

Fizan Abdullah, MD, PhD

A

Arianna Edobor, CRC

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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