Mode
Text Size
Log in / Sign up
N/A N=252 Randomized Supportive Care

iTRACC (Improving Technology-Assisted Recording of Asthma Control in Children)

Asthma

Enrolled (actual)
252
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Asthma Control Test (ACT) — 21.8; 19.9 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Remote Health Management Sensor Platform (Device)
Age
Pediatric · 4+ yrs
Sex
All
Sponsor
Dr. Deneen Vojta
Primary completion
Dec 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Asthma Control Test (ACT)
21.8; 19.9
PRIMARY
Frequency of Urgent Health Utilization
1.0; .6
PRIMARY
12 Month Rate of Medication Use
1.3; .9
PRIMARY
Frequency of Asthma-related Hospitalizations
.4; .1
SECONDARY
Pediatric Asthma Caregiver Quality of Life (QOL) Questionnaire
6.3; 6.0

Summary

The goal of this study is to determine whether a sensor-enabled, clinically integrated, mobile health asthma program can improve asthma outcomes among 4-17 year old children with moderate-to-severe asthma.

Eligibility Criteria

Inclusion Criteria

  • English-speaking parents
  • Children 4-<17 years of age. Using both NHLBI (National Heart, Lung, and Blood Institute) guidelines and based off of a physician expert panel, the research team has limited the ages to 4-<17 years old. It has been shown to be difficult to properly diagnose individuals less than 4 years of age with asthma. Usually, they are diagnosed with reactive airway disease or bronchial virus. Individuals <17 years old was the oldest group because investigators wanted to avoid adolescence and make sure that parents have an active role in the health management of the child.
  • Moderate or severe persistent asthma, defined by the National Heart, Lung, and Blood Institute. This will be done by a physician-trained research assistant who will be able to identify potential participants prior to recruitment.
  • At least one asthma exacerbations that required a course of oral corticosteroids in the past year
  • Prescription and utilization of an ICS inhaler for at least the past year.
  • Who are seen at: Clark and Deming Resident Clinic, Lurie Children's Pulmonary Clinic, Lurie Children's Uptown Clinic, Chicago Family Asthma and Allergy Clinic or Children's Healthcare Associates

Exclusion Criteria

  • Non-English speaking parents/families
  • Patients seen in the hospital who receive primary care outside of the study's clinics
  • Children with any comorbid conditions, which interfere with appropriate assessment of asthma symptoms: Chronic Lung Disease, Broncho-Pulmonary Dysplasia, Cystic Fibrosis, Pulmonary Hypertension, Interstitial Lung Disease, Immunodeficiency, Bronchiectasis, Primary Ciliary Dyskinesia, Chronic Respiratory Insufficiency, Neuromuscular Weakness, Sickle Cell Lung Disease, Restrictive Lung Disease, and Tracheostomy or Ventilator-dependence
  • Child-patients who are participating in any other research studies that would interfere with our ability to use and track the inhaler sensor
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02994238). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search