N/A
N=252
iTRACC (Improving Technology-Assisted Recording of Asthma Control in Children)
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT02994238 ↗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
| Outcome | Result | p-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
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.