Community Empowerment to Pilot a Novel Device for Monitoring Rescue Medication Use in Urban Children With Asthma

Study Overview
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Brief Summary
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Background: Pediatric asthma is the most common chronic illness among children and is associated with poor quality of life, activity restriction, school absences, and thousands of physician visits annually. The purpose of this study is to measure the effectiveness of using an innovative tracking system (CareTRx) for the self-management of asthma, including daily and rescue medication use, among children and adolescents with pediatric asthma.

Detailed Description
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The primary study objective is to measure the effectiveness of using an innovative tracking system (CareTRx) for the self-management of asthma, including daily and rescue medication use, among children with asthma. The study objectives will be achieved using a pre-post design for the participants. The investigators aim to enroll at least 26 participants for a 3-month intervention period. With this pilot study, the investigators hope to examine the impact of self-management behaviors on health outcomes including asthma symptoms and quality of life measures.

Official Title
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Community Empowerment to Pilot a Novel Device for Monitoring Rescue Medication Use in Urban Children With Asthma

Conditions
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Asthma

Intervention / Treatment
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* Device: CareTRx


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Youth with a primary diagnosis of persistent asthma according by NHLBI criteria Females or males between the ages of 6-17 years of age Youth or caregiver must have an Android smart phone with operating system 4.3 or above and data plan for the duration of the study period Exclusion Criteria: Youth with other cardiac, pulmonary, or neuromuscular disorders that impact breathing Youth with documented developmental delays or impairments that would interfere with ability to use CareTRx system

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CareTRx Device<br>Subject will receive CareTRx device for rescue inhaler as well as the application downloaded to their Android phone. The device will track when the rescue inhaler is administered. The information will then be loaded to phone app. | Device: CareTRx<br>* CareTRx is a novel device that can be applied to most MDI (meter dose inhaler) device and leverages mobile and cloud computing to objectively assess and provide real-visualize feedback to patients and providers around medication adherence and disease control in pediatric asthma.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Daily Medication Compliance | Total number participants who took their medication as planned will be measured. This will include measuring the number of participants with medication compliance who take their medications as planned based on the data from the monitoring device. | 12 weeks | 
| Number of Participants With Rescue Inhaler Use | Total number participants with rescue inhaler use throughout the course of the study. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Symptoms | Asthma symptom control as a measure of effectiveness of self-management behavior on asthma control, measured by Asthma Control Test (ACT). Asthma control test is a survey used to evaluate asthma control in patients. It includes 5 multiple questions that ask about how much of the time patient was having asthma symptoms. The higher the score the better asthma control. Lower scores especially less than 19 represent poor asthma control. each question has 5 answers. The total score is the sum of all the scores from 5 questions. the maximum score on the test is 25 which is excellent asthma control and the lowest is 0 which defines extremely poor asthma control. | 12 weeks | 
| Forced Expiratory Volume | Forced expiratory volume measured in liters is the volume of air which can be forcibly exhaled from the lungs in the first second of a forced expiration and helps with evaluation of asthma control. FEV1 was only measure at baseline to assess the participants asthma status at baseline. | Baseline |