Early Detection of Infection Using the Fitbit in Pediatric Surgical Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-18
SponsorAnn & Robert H Lurie Children's Hospital of Chicago
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.)
Disqualifiers
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 design
Design model
Sequential
Treatments tested in this trial
Infection-Prediction Algorithm
DeviceThis 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.
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: Aim 1 - ValidationNo intervention 0 interventions
Group B: Aim 2 - Implementation of AlgorithmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
Fitbit data metrics will be collected for 30 days starting at date of enrollment.Secondary outcomes
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.
Time frame
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.
Time frame
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.
Time frame
For 30 days starting at day of participant enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ann & Robert H Lurie Children's Hospital of Chicago
Lead sponsor
Northwestern University
Collaborator
Central DuPage Hospital
Collaborator
University of Chicago
Collaborator
Loyola University Chicago
Collaborator
Source ClinicalTrials.gov