Trial Outcomes & Findings for The Study is Enrolling Kids From 8 to 17 Years Old. The BreathSmart Device Attaches to the Inhaler to Measure Adherence. (NCT NCT03734861)
NCT ID: NCT03734861
Last Updated: 2023-04-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
75 participants
Primary outcome timeframe
6 months post start of intervention
Results posted on
2023-04-07
Participant Flow
Participant milestones
| Measure |
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: 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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
25
|
|
Overall Study
COMPLETED
|
50
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Study is Enrolling Kids From 8 to 17 Years Old. The BreathSmart Device Attaches to the Inhaler to Measure Adherence.
Baseline characteristics by cohort
| Measure |
BreatheSmart System
n=50 Participants
* 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
|
Standard of Care
n=25 Participants
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.
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
12.2 years
STANDARD_DEVIATION 3 • n=99 Participants
|
11.7 years
STANDARD_DEVIATION 2.8 • n=107 Participants
|
12 years
STANDARD_DEVIATION 2.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=99 Participants
|
25 participants
n=107 Participants
|
75 participants
n=206 Participants
|
|
Proportion of days covered (PDC)
|
0.41 proportion of days
STANDARD_DEVIATION 0.30 • n=99 Participants
|
0.41 proportion of days
STANDARD_DEVIATION 0.27 • n=107 Participants
|
0.41 proportion of days
STANDARD_DEVIATION 0.29 • n=206 Participants
|
PRIMARY outcome
Timeframe: 6 months post start of interventionPopulation: 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
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.
Outcome measures
| Measure |
BreatheSmart System
n=50 Participants
* 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: 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
|
Standard of Care
n=25 Participants
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.
|
|---|---|---|
|
Proportion of Days Covered (PDC)
|
0.39 proportion of days
Standard Deviation 0.34
|
0.33 proportion of days
Standard Deviation 0.30
|
SECONDARY outcome
Timeframe: 6 months post start of interventionPopulation: 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.
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.
Outcome measures
| Measure |
BreatheSmart System
n=50 Participants
* 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: 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
|
Standard of Care
n=25 Participants
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.
|
|---|---|---|
|
Asthma Control Test
ACT baseline
|
18.9 score on a scale
Standard Deviation 4.5
|
17.9 score on a scale
Standard Deviation 5.5
|
|
Asthma Control Test
ACT 3 months
|
21.2 score on a scale
Standard Deviation 3.7
|
20 score on a scale
Standard Deviation 3.4
|
|
Asthma Control Test
ACT 6 months
|
19.7 score on a scale
Standard Deviation 3.1
|
17.9 score on a scale
Standard Deviation 5.6
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Participants in both arms performed spirometry during clinic visits
The percent predicted forced expiratory volume in 1 second (FEV1) were evaluated at baseline, 3-months, and 6-months.
Outcome measures
| Measure |
BreatheSmart System
n=50 Participants
* 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: 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
|
Standard of Care
n=23 Participants
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.
|
|---|---|---|
|
FEV1% Predicted
Baseline
|
89.7 percentage of predicted FEV1
Standard Deviation 18.2
|
92.4 percentage of predicted FEV1
Standard Deviation 15
|
|
FEV1% Predicted
3-months
|
86.5 percentage of predicted FEV1
Standard Deviation 12.9
|
99.7 percentage of predicted FEV1
Standard Deviation 17.8
|
|
FEV1% Predicted
6-months
|
90.5 percentage of predicted FEV1
Standard Deviation 16.3
|
103.6 percentage of predicted FEV1
Standard Deviation 14.8
|
SECONDARY outcome
Timeframe: Baseline to 6 months post start of interventionPopulation: The analysis population was comprised of children enrolled in either the control (standard of care) arm or the intervention (Breathesmart, HeroTracker) arm.
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.
Outcome measures
| Measure |
BreatheSmart System
n=50 Participants
* 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: 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
|
Standard of Care
n=25 Participants
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.
|
|---|---|---|
|
Changes in Medication Adherence and Lung Function
FEV1% predicted
|
0.221 Spearman's correlation coefficient
|
0.283 Spearman's correlation coefficient
|
|
Changes in Medication Adherence and Lung Function
FEV1/FVC
|
-0.081 Spearman's correlation coefficient
|
0.174 Spearman's correlation coefficient
|
SECONDARY outcome
Timeframe: Baseline to 6 months post start of interventionThe overall number of participant-reported provider visits for asthma healthcare utilization (e.g. number of self-reported exacerbations leading to ER visits)
Outcome measures
| Measure |
BreatheSmart System
n=50 Participants
* 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: 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
|
Standard of Care
n=25 Participants
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.
|
|---|---|---|
|
Number of Participants With Visits to ER for Asthma
ED visits 3 months
|
0 Participants
|
1 Participants
|
|
Number of Participants With Visits to ER for Asthma
ED visits 6 months
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Last 30 days from baseline visit and last 30 days from 6-month follow-up visitAverage number of days missed from school in the past 30 days
Outcome measures
| Measure |
BreatheSmart System
n=50 Participants
* 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: 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
|
Standard of Care
n=25 Participants
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.
|
|---|---|---|
|
Number of Missed Days of School
Past 30 days from Baseline
|
1.12 days
Standard Deviation 1.9
|
1.04 days
Standard Deviation 1.8
|
|
Number of Missed Days of School
Past 30 days from 6-month follow-up
|
2.1 days
Standard Deviation 1.5
|
3.3 days
Standard Deviation 3.1
|
Adverse Events
BreatheSmart System
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Standard of Care
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BreatheSmart System
n=50 participants at risk
* 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: 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
|
Standard of Care
n=25 participants at risk
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.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Caregiver-reported emergency department visit for asthma exacerbation
|
6.0%
3/50 • 2 years
|
16.0%
4/25 • 2 years
|
Additional Information
Dr. Jessica Hollenbach, PhD
Connecticut Children's Medical Center, Asthma Center
Phone: 860-837-5333
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place