Asthma
Conditions
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.
Interventions
DEVICECareTRx
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.
Sponsors
Boston Children's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Daily Medication Compliance | 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. |
| Number of Participants With Rescue Inhaler Use | 12 weeks | Total number participants with rescue inhaler use throughout the course of the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Asthma Symptoms | 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. |
| Forced Expiratory Volume | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
CareTRx: 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. | 26 |
| Total | 26 |
Baseline characteristics
| Characteristic | CareTRx Device |
|---|---|
| Age, Categorical <=18 years | 26 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 9.1 years |
| Asthma control test | 20.6 units on a scale STANDARD_DEVIATION 3.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 26 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 |
Outcome results
Primary
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.
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CareTRx Device | Number of Participants With Daily Medication Compliance | 24 Participants |
Primary
Number of Participants With Rescue Inhaler Use
Total number participants with rescue inhaler use throughout the course of the study.
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CareTRx Device | Number of Participants With Rescue Inhaler Use | 24 Participants |
Secondary
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CareTRx Device | Asthma Symptoms | 21.6 units on a scale | Standard Deviation 3.9 |
Secondary
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CareTRx Device | Forced Expiratory Volume | 1.56 liters | Standard Deviation 0.62 |