Asthma
Conditions
Keywords
Asthma
Brief summary
Non-adherence to controller medication is a common problem in children with Asthma, resulting in overuse of reliever medication, increased asthma symptoms, more frequent Asthma attacks, and increased emergency room visits and hospital admissions. Additionally, current absence of a gold standard to measure adherence forces clinicians and researchers to rely on patient-self report, which is notoriously inaccurate, to support clinical decision making. Many young patients suffer from both intentional and non-intentional non-adherence, thus an appropriate intervention must address both types. Current studies using electronic monitoring devices (EMDs) primarily focus on non-intentional non-adherence through reminder systems and thus are limited in their ability to engage patients for long-term behavior change. This trial addresses an important knowledge gap by evaluating whether EMDs with a combination of reminder system and patient education can prove to be effective in increasing adherence rates and can be used in clinical practice to achieve better asthma control and outcomes through improved patient and clinician engagement.
Detailed description
This is a prospective, randomized, controlled study of children with persistent asthma who are managed on daily inhaled corticosteroids (ICS). 75 children will be randomized 2:1 into one of two arms: * 50 children will be randomized to BreatheSmart, comprised of: * BreatheSmart mobile application that tracks medication usage and sends real time reminders * HeroTracker sensor that counts dosage and monitors real-time medication adherence * CoheroConnect provider portal that allows the Investigator to monitor real-time adherence and to provide targeted outreach to children with low adherence (intervention arm) * 25 children will be randomized to standard of care(control arm). These patients are reminded to adhere to the prescribed standard of care therapy provided by their clinician during their clinical encounters and when the family calls to report an illness.
Interventions
DEVICEBreatheSmart System
* BreatheSmart System: a mobile application that tracks medication usage and sends real time reminders * HeroTracker sensor that counts dosage and monitors real-time medication adherence * CoheroConnect provider portal that allows the Investigator to monitor adherence
OTHERStandard of Care
These patients are reminded to adhere to the prescribed standard of care therapy provided by their clinician during their clinical encounters and when the family calls to report an illness.
Sponsors
Connecticut Children's Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Patients will be randomized to one of two arms: 1. BreathSmart system 2. Standard of Care
Eligibility
Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Age 8 to 17 * Diagnosis of persistent asthma * Prescribed an inhaled corticosteroid (ICS) for at least one month prior to enrollment * Use of a pressurized metered dose inhaler (pMDI) compatible with the Cohero mHealth Herotracker (See Appendix) * Parent/child possess a compatible smartphone (iOS 8.0 or higher) * English or Spanish speaking
Exclusion criteria
* Presence of another chronic lung disease or condition such as cystic fibrosis, interstitial lung disease, chronic lung disease of prematurity, recurrent aspiration, or presence of tracheostomy * Presence of other chronic medical condition such as congenital heart disease or immunodeficiency * Presence of other comorbidities that, in the opinion of the investigator, will interfere with collection of study procedures, or limits life expectancy to \< 1 year * Currently pregnant or planning to become pregnant during the trial period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Days Covered (PDC) | 6 months post start of intervention | Medication adherence among children using BreatheSmart with feedback (intervention) compared to control group (standard of care) at 6 months. The primary outcome was medication adherence as measured using pharmacy refill. Medication adherence as measured by pharmacy refills was calculated using proportion of days covered (PDC), a validated method of calculating adherence, defined as a ratio of the sum of unique days supplied based on refills over the total number of days in the assessed period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Asthma Control Test | 6 months post start of intervention | The Asthma control Test (ACT) assess a patient's level of asthma control based on responses to 5 symptom-related questions over the past 4 weeks. Respondents must select a number on a 5-point likert scale (1-5) for each item. The response to each question is summed, ranging from 5-25. Scores of 19 or less indicate poorly controlled asthma. Higher scores mean better asthma control. |
| FEV1% Predicted | Baseline to 6 months | The percent predicted forced expiratory volume in 1 second (FEV1) were evaluated at baseline, 3-months, and 6-months. |
| Changes in Medication Adherence and Lung Function | Baseline to 6 months post start of intervention | The correlation between changes in medication adherence and changes in FEV1 percent predicted. FEV1 is forced expiratory volume in 1 second is the maximum amount of air that a subject can forcibly expel during the first second following maximal inhalation. FEV1 can be useful to categorize the severity of asthma. Expressing FEV1 as a percentage of the predicted value in a patient is means by which to express this severity. |
| Number of Participants With Visits to ER for Asthma | Baseline to 6 months post start of intervention | The overall number of participant-reported provider visits for asthma healthcare utilization (e.g. number of self-reported exacerbations leading to ER visits) |
| Number of Missed Days of School | Last 30 days from baseline visit and last 30 days from 6-month follow-up visit | Average number of days missed from school in the past 30 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BreatheSmart System * BreatheSmart mobile application that tracks medication usage and sends real time reminders
* HeroTracker sensor that counts dosage and monitors real-time medication adherence
* CoheroConnect provider portal that allows the Investigator to monitor real-time adherence and to provide targeted outreach to children with low adherence (intervention arm)
BreatheSmart System: ○ BreatheSmart System: a mobile application that tracks medication usage and sends real time reminders
* HeroTracker sensor that counts dosage and monitors real-time medication adherence
* CoheroConnect provider portal that allows the Investigator to monitor adherence | 50 |
| Standard of Care These patients are reminded to adhere to the prescribed standard of care therapy provided by their clinician during their clinical encounters and when the family calls to report an illness.
Standard of Care: These patients are reminded to adhere to the prescribed standard of care therapy provided by their clinician during their clinical encounters and when the family calls to report an illness. | 25 |
| Total | 75 |
Baseline characteristics
| Characteristic | Standard of Care | Total | BreatheSmart System |
|---|---|---|---|
| Age, Continuous | 11.7 years STANDARD_DEVIATION 2.8 | 12 years STANDARD_DEVIATION 2.9 | 12.2 years STANDARD_DEVIATION 3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 34 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 41 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Proportion of days covered (PDC) | 0.41 proportion of days STANDARD_DEVIATION 0.27 | 0.41 proportion of days STANDARD_DEVIATION 0.29 | 0.41 proportion of days STANDARD_DEVIATION 0.3 |
| Region of Enrollment United States | 25 participants | 75 participants | 50 participants |
| Sex: Female, Male Female | 14 Participants | 40 Participants | 26 Participants |
| Sex: Female, Male Male | 11 Participants | 35 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 25 |
| other Total, other adverse events | 3 / 50 | 4 / 25 |
| serious Total, serious adverse events | 0 / 50 | 0 / 25 |
Outcome results
Primary
Proportion of Days Covered (PDC)
Medication adherence among children using BreatheSmart with feedback (intervention) compared to control group (standard of care) at 6 months. The primary outcome was medication adherence as measured using pharmacy refill. Medication adherence as measured by pharmacy refills was calculated using proportion of days covered (PDC), a validated method of calculating adherence, defined as a ratio of the sum of unique days supplied based on refills over the total number of days in the assessed period.
Time frame: 6 months post start of intervention
Population: Participants in the BreatheSmart arm (intervention) received the EMD, app, and reminder notifications. Participants in the control group continued to receive routine clinical care. They were reminded to adhere to prescribed therapy during their clinical encounters
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BreatheSmart System | Proportion of Days Covered (PDC) | 0.39 proportion of days | Standard Deviation 0.34 |
| Standard of Care | Proportion of Days Covered (PDC) | 0.33 proportion of days | Standard Deviation 0.3 |
Secondary
Asthma Control Test
The Asthma control Test (ACT) assess a patient's level of asthma control based on responses to 5 symptom-related questions over the past 4 weeks. Respondents must select a number on a 5-point likert scale (1-5) for each item. The response to each question is summed, ranging from 5-25. Scores of 19 or less indicate poorly controlled asthma. Higher scores mean better asthma control.
Time frame: 6 months post start of intervention
Population: Participants in the intervention group received an electronic monitoring device (Herotracker), which is synced to the BreathSmart mobile app, designed to send reminder notifications to participants, and are able to collect medication adherence data. Participants are able to track and review their medication adherence using the app. Participants in the control group continued to receive routine clinical care. They were reminded to adhere to prescribed therapy during their clinical encounters.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BreatheSmart System | Asthma Control Test | ACT baseline | 18.9 score on a scale | Standard Deviation 4.5 |
| BreatheSmart System | Asthma Control Test | ACT 3 months | 21.2 score on a scale | Standard Deviation 3.7 |
| BreatheSmart System | Asthma Control Test | ACT 6 months | 19.7 score on a scale | Standard Deviation 3.1 |
| Standard of Care | Asthma Control Test | ACT baseline | 17.9 score on a scale | Standard Deviation 5.5 |
| Standard of Care | Asthma Control Test | ACT 3 months | 20 score on a scale | Standard Deviation 3.4 |
| Standard of Care | Asthma Control Test | ACT 6 months | 17.9 score on a scale | Standard Deviation 5.6 |
Secondary
Changes in Medication Adherence and Lung Function
The correlation between changes in medication adherence and changes in FEV1 percent predicted. FEV1 is forced expiratory volume in 1 second is the maximum amount of air that a subject can forcibly expel during the first second following maximal inhalation. FEV1 can be useful to categorize the severity of asthma. Expressing FEV1 as a percentage of the predicted value in a patient is means by which to express this severity.
Time frame: Baseline to 6 months post start of intervention
Population: The analysis population was comprised of children enrolled in either the control (standard of care) arm or the intervention (Breathesmart, HeroTracker) arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BreatheSmart System | Changes in Medication Adherence and Lung Function | FEV1% predicted | 0.221 Spearman's correlation coefficient |
| BreatheSmart System | Changes in Medication Adherence and Lung Function | FEV1/FVC | -0.081 Spearman's correlation coefficient |
| Standard of Care | Changes in Medication Adherence and Lung Function | FEV1% predicted | 0.283 Spearman's correlation coefficient |
| Standard of Care | Changes in Medication Adherence and Lung Function | FEV1/FVC | 0.174 Spearman's correlation coefficient |
Secondary
FEV1% Predicted
The percent predicted forced expiratory volume in 1 second (FEV1) were evaluated at baseline, 3-months, and 6-months.
Time frame: Baseline to 6 months
Population: Participants in both arms performed spirometry during clinic visits
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BreatheSmart System | FEV1% Predicted | Baseline | 89.7 percentage of predicted FEV1 | Standard Deviation 18.2 |
| BreatheSmart System | FEV1% Predicted | 3-months | 86.5 percentage of predicted FEV1 | Standard Deviation 12.9 |
| BreatheSmart System | FEV1% Predicted | 6-months | 90.5 percentage of predicted FEV1 | Standard Deviation 16.3 |
| Standard of Care | FEV1% Predicted | Baseline | 92.4 percentage of predicted FEV1 | Standard Deviation 15 |
| Standard of Care | FEV1% Predicted | 3-months | 99.7 percentage of predicted FEV1 | Standard Deviation 17.8 |
| Standard of Care | FEV1% Predicted | 6-months | 103.6 percentage of predicted FEV1 | Standard Deviation 14.8 |
Secondary
Number of Missed Days of School
Average number of days missed from school in the past 30 days
Time frame: Last 30 days from baseline visit and last 30 days from 6-month follow-up visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BreatheSmart System | Number of Missed Days of School | Past 30 days from Baseline | 1.12 days | Standard Deviation 1.9 |
| BreatheSmart System | Number of Missed Days of School | Past 30 days from 6-month follow-up | 2.1 days | Standard Deviation 1.5 |
| Standard of Care | Number of Missed Days of School | Past 30 days from Baseline | 1.04 days | Standard Deviation 1.8 |
| Standard of Care | Number of Missed Days of School | Past 30 days from 6-month follow-up | 3.3 days | Standard Deviation 3.1 |
Secondary
Number of Participants With Visits to ER for Asthma
The overall number of participant-reported provider visits for asthma healthcare utilization (e.g. number of self-reported exacerbations leading to ER visits)
Time frame: Baseline to 6 months post start of intervention
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BreatheSmart System | Number of Participants With Visits to ER for Asthma | ED visits 3 months | 0 Participants |
| BreatheSmart System | Number of Participants With Visits to ER for Asthma | ED visits 6 months | 3 Participants |
| Standard of Care | Number of Participants With Visits to ER for Asthma | ED visits 3 months | 1 Participants |
| Standard of Care | Number of Participants With Visits to ER for Asthma | ED visits 6 months | 3 Participants |