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Completed

NCT Number: NCT02517047

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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CareTRx

Device

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.

Primary outcomes

  1. 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.

  2. Number of Participants With Rescue Inhaler Use

    Time frame: 12 weeks

    Total number participants with rescue inhaler use throughout the course of the study.

Secondary outcomes

  1. Asthma Symptoms

    Time frame: 12 weeks

    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.

  2. Forced Expiratory Volume

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Aug 6, 2015
Registry last updated
Jun 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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