Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BreatheSmart System | Experimental |
|
|
| Standard of Care | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BreatheSmart System | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months post start of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tregony Simoneau, MD | Connecticut Childrens Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35691614 | Derived | Chan A, De Simoni A, Wileman V, Holliday L, Newby CJ, Chisari C, Ali S, Zhu N, Padakanti P, Pinprachanan V, Ting V, Griffiths CJ. Digital interventions to improve adherence to maintenance medication in asthma. Cochrane Database Syst Rev. 2022 Jun 13;6(6):CD013030. doi: 10.1002/14651858.CD013030.pub2. | |
| 33644492 | Derived |
Not provided
Not provided
NA we are not planning on sharing the data
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | BreatheSmart System |
|
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BreatheSmart System |
BreatheSmart System: ○ BreatheSmart System: a mobile application that tracks medication usage and sends real time reminders
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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 | Posted | Mean | Standard Deviation | proportion of days | 6 months post start of intervention |
|
2 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BreatheSmart System |
|
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Caregiver-reported emergency department visit for asthma exacerbation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
The intervention sample size was limited by the number of EMDs provided by CoHero. In addition, EMD adherence rates cannot directly be compared between the intervention and control groups because of the study design. Furthermore, at the initiation of the study, CoHero had not designed the BreatheSmart app for compatibility with Android smartphones. Thus, a significant proportion of potentially eligible children were18 excluded because of Android phone ownership.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jessica Hollenbach, PhD | Connecticut Children's Medical Center, Asthma Center | 860-837-5333 | jhollenbach@connecticutchildrens.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 12, 2019 | Jan 13, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 4, 2019 | Nov 8, 2022 | ICF_002.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
Patients will be randomized to one of two arms:
Not provided
Not provided
Not provided
Not provided
|
| Standard of Care | Other | 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. |
|
| 6 months post start of intervention |
| FEV1% Predicted | The percent predicted forced expiratory volume in 1 second (FEV1) were evaluated at baseline, 3-months, and 6-months. | Baseline to 6 months |
| 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. | Baseline to 6 months post start of intervention |
| 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) | Baseline to 6 months post start of intervention |
| Number of Missed Days of School | Average number of days missed from school in the past 30 days | Last 30 days from baseline visit and last 30 days from 6-month follow-up visit |
| Hollenbach J, Simoneau T, Sun Y, Becene I, Almeida S, Langton C, Flores G. Design, methods, and baseline characteristics of a pilot, randomized, controlled trial of the effects of an electronic monitoring device on medication adherence in children with asthma. Contemp Clin Trials Commun. 2021 Feb 6;21:100706. doi: 10.1016/j.conctc.2021.100706. eCollection 2021 Mar. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Proportion of days covered (PDC) | The primary outcome is medication adherence as measured using pharmacy refills. 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. For baseline adherence, PDC was assessed over a six-month period prior to the enrollment date. | Mean | Standard Deviation | proportion of days |
|
| OG001 | 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. |
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months post start of intervention |
|
|
|
| Secondary | FEV1% Predicted | The percent predicted forced expiratory volume in 1 second (FEV1) were evaluated at baseline, 3-months, and 6-months. | Participants in both arms performed spirometry during clinic visits | Posted | Mean | Standard Deviation | percentage of predicted FEV1 | Baseline to 6 months |
|
|
|
| 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. | The analysis population was comprised of children enrolled in either the control (standard of care) arm or the intervention (Breathesmart, HeroTracker) arm. | Posted | Number | Spearman's correlation coefficient | Baseline to 6 months post start of intervention |
|
|
|
| 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) | Posted | Count of Participants | Participants | Baseline to 6 months post start of intervention |
|
|
|
| Secondary | Number of Missed Days of School | Average number of days missed from school in the past 30 days | Posted | Mean | Standard Deviation | days | Last 30 days from baseline visit and last 30 days from 6-month follow-up visit |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 3 |
| 50 |
| EG001 | 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. | 0 | 25 | 0 | 25 | 4 | 25 |
Not provided
Not provided
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| ACT 6 months |
|
| 6-months |
|