Actively Recruiting
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
Eligibility Criteria
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)
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
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
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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