Clinical trial NCT02517047: Community Empowerment to Pilot a Novel Device for Monitoring Rescue Medication Use in Urban Children With Asthma
Official title: Community Empowerment to Pilot a Novel Device for Monitoring Rescue Medication Use in Urban Children With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2015-08-06
Enrollment: 26
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

1. Youth with a primary diagnosis of persistent asthma according by NHLBI criteria
2. Females or males between the ages of 6-17 years of age
3. 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:

1. Youth with other cardiac, pulmonary, or neuromuscular disorders that impact breathing
2. Youth with documented developmental delays or impairments that would interfere with ability to use CareTRx system

Primary outcomes:
measure: Number of Participants With Daily Medication Compliance
timeFrame: 12 weeks
measure: Number of Participants With Rescue Inhaler Use
timeFrame: 12 weeks
Secondary outcomes:
measure: Asthma Symptoms
timeFrame: 12 weeks
measure: Forced Expiratory Volume
timeFrame: Baseline
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Wanda Phipatanakul, MD, MS
role: PRINCIPAL_INVESTIGATOR
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