Community Empowerment to Pilot a Novel Device for Monitoring Rescue Medication Use in Urban Children With Asthma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Boston Children's Hospital
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Number of Participants With Rescue Inhaler Use
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
CareTRx Device
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.
Intervention: CareTRx (Device)
Outcomes
Primary Outcomes
Number of Participants With Rescue Inhaler Use
Time Frame: 12 weeks
Total number participants with rescue inhaler use throughout the course of the study.
Number of Participants With Daily Medication Compliance
Time Frame: 12 weeks
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.
Secondary Outcomes
- Asthma Symptoms(12 weeks)
- Forced Expiratory Volume(Baseline)
Investigators
Wanda Phipatanakul
Principle Investigator
Boston Children's Hospital