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Behavioural Intervention
Fitbit Data for Detecting Infections After Appendicitis Surgery (i-DETECT Trial)
N/A
Waitlist Available
Led By Arun Jayaraman, PT, PhD
Research Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Children aged 3-18 years
Must have undergone post-surgical laparoscopic appendectomy for complicated appendicitis (Appendicitis is categorized as complicated if perforation, phlegmon, or abscess was present at surgery)
Must not have
Children who are non-ambulatory or have any pre-existing mobility limitations
Children and/or parents who do not speak English or Spanish (Translation services beyond Spanish will not be available at this time)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up for 30 days starting at day of participant enrollment
Awards & highlights
Summary
This trial aims to use Fitbit data to predict infections after surgery for complicated appendicitis and see how this prediction impacts doctors' decisions. "This trial aims to predict infections after surgery for complicated append
Who is the study for?
This trial is for pediatric patients who have undergone surgery for complicated appendicitis. Specific eligibility criteria are not provided, but typically participants would be children with recent appendectomies.
What is being tested?
The study is testing an infection-prediction algorithm using data from Fitbits to foresee infections after appendectomy in young patients and how these predictions influence doctors' decisions.
What are the potential side effects?
Since the intervention involves data analysis rather than a physical treatment, there are no direct side effects associated with this trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 3 and 18 years old.
Select...
I had surgery to remove my appendix due to severe infection or rupture.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My child cannot walk or has difficulty moving around.
Select...
I (or my child) do not speak English or Spanish.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ fitbit data metrics will be collected for 30 days starting at date of enrollment.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~fitbit data metrics will be collected for 30 days starting at date of enrollment.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Trends in Participant Fitbit Data (Physical Activity, Heart Rate, Sleep) during the Recovery Period post Complicated Appendectomy
Secondary study objectives
Change in Clinician Decision Making from Algorithm Results
Healthcare Utilizations during Recovery Period
Number of Reported Symptoms and Complications during Recovery
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Aim 2 - Implementation of AlgorithmExperimental Treatment1 Intervention
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.
Group II: Aim 1 - ValidationActive Control1 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.
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Who is running the clinical trial?
Loyola University ChicagoOTHER
21 Previous Clinical Trials
12,588 Total Patients Enrolled
Ann & Robert H Lurie Children's Hospital of ChicagoLead Sponsor
264 Previous Clinical Trials
5,182,184 Total Patients Enrolled
Northwestern UniversityOTHER
1,630 Previous Clinical Trials
955,785 Total Patients Enrolled
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