Back to resultsCommunity Empowerment to Pilot a Novel Device for Monitoring Rescue Medication Use in Urban Children With Asthma
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CareTRx
Sponsored by
About this trial
This is an interventional supportive care trial for Asthma
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
Sites / Locations
- Boston Children's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CareTRx Device
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Number of Participants With Rescue Inhaler Use
Total number participants with rescue inhaler use throughout the course of the study.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02517047
Brief Title
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
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CareTRx Device
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
CareTRx
Intervention Description
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 Outcome Measure Information:
Title
Number of Participants With Daily Medication Compliance
Description
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.
Time Frame
12 weeks
Title
Number of Participants With Rescue Inhaler Use
Description
Total number participants with rescue inhaler use throughout the course of the study.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Asthma Symptoms
Description
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.
Time Frame
12 weeks
Title
Forced Expiratory Volume
Description
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.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wanda Phipatanakul, MD, MS
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Citations:
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Community Empowerment to Pilot a Novel Device for Monitoring Rescue Medication Use in Urban Children With Asthma
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