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Clinical Trials/NCT02517047
NCT02517047
Completed
Not Applicable

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

Boston Children's Hospital1 site in 1 country26 target enrollmentMarch 2016
ConditionsAsthma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Asthma
Sponsor
Boston Children's Hospital
Enrollment
26
Locations
1
Primary Endpoint
Number of Participants With Rescue Inhaler Use
Status
Completed
Last Updated
7 years ago

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.

Registry
clinicaltrials.gov
Start Date
March 2016
End Date
December 2016
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Wanda Phipatanakul

Principle Investigator

Boston Children's Hospital

Eligibility Criteria

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

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)

Study Sites (1)

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