Trial Outcomes & Findings for Breathing Counts: Evaluating Adherence in the Presence of Asthma Navigation Support (NCT NCT03065205)
NCT ID: NCT03065205
Last Updated: 2019-12-27
Results Overview
Adherence will be measured via adherence monitoring devices for 6 months per patient. Change in device measured adherence from week 1 to week 24. Measured as change in average number of puffs of controller medication taken/puffs individually prescribed, measured between weeks 1 and 24.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
65 participants
Primary outcome timeframe
Week 1 to Week 24
Results posted on
2019-12-27
Participant Flow
Participant milestones
| Measure |
Single Arm
Patients will have adherence monitoring devices placed on their asthma inhalers (both daily and rescue medication). Adherence information will be sent to their PCP, specialist and school nurse monthly. Additionally, the navigator will speak with families every 2 months to discuss adherence data and address barriers.
Propeller Health device + asthma navigator: The patients will be monitored using the propeller health device for 6 months. The patients will be contacted at 2 month intervals by an asthma health educator to discuss barriers to adherence to asthma medications
|
|---|---|
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Overall Study
STARTED
|
65
|
|
Overall Study
COMPLETED
|
53
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Breathing Counts: Evaluating Adherence in the Presence of Asthma Navigation Support
Baseline characteristics by cohort
| Measure |
Single Arm
n=65 Participants
Patients will have adherence monitoring devices placed on their asthma inhalers (both daily and rescue medication). Adherence information will be sent to their PCP, specialist and school nurse monthly. Additionally, the navigator will speak with families every 2 months to discuss adherence data and address barriers.
Propeller Health device + asthma navigator: The patients will be monitored using the propeller health device for 6 months. The patients will be contacted at 2 month intervals by an asthma health educator to discuss barriers to adherence to asthma medications
|
|---|---|
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Age, Continuous
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9.08 years
STANDARD_DEVIATION 2.51 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
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1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 1 to Week 24Population: Participants who were in the study for the 6 month period and had analyzable study data for at least 16 weeks of monitored time.
Adherence will be measured via adherence monitoring devices for 6 months per patient. Change in device measured adherence from week 1 to week 24. Measured as change in average number of puffs of controller medication taken/puffs individually prescribed, measured between weeks 1 and 24.
Outcome measures
| Measure |
Single Arm
n=42 Participants
Patients will have adherence monitoring devices placed on their asthma inhalers (both daily and rescue medication). Adherence information will be sent to their PCP, specialist and school nurse monthly. Additionally, the navigator will speak with families every 2 months to discuss adherence data and address barriers.
Propeller Health device + asthma navigator: The patients will be monitored using the propeller health device for 6 months. The patients will be contacted at 2 month intervals by an asthma health educator to discuss barriers to adherence to asthma medications
|
|---|---|
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Change in Adherence of Use of Patient Asthma Inhalers
|
-0.36 Change in puffs taken/prescribed per wk
Interval -0.62 to -0.23
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SECONDARY outcome
Timeframe: 6 monthsPopulation: Total number of participants who responded to the 6 month survey.
Measured via questionnaire data using Asthma Control Test (ACT) or Childhood Asthma Control Test (cACT) every 2 months. Reported at 6 months. Scores range from 5-25 on the ACT and 0-27 on the cACT. Scores \>19 on either test indicate good asthma control
Outcome measures
| Measure |
Single Arm
n=34 Participants
Patients will have adherence monitoring devices placed on their asthma inhalers (both daily and rescue medication). Adherence information will be sent to their PCP, specialist and school nurse monthly. Additionally, the navigator will speak with families every 2 months to discuss adherence data and address barriers.
Propeller Health device + asthma navigator: The patients will be monitored using the propeller health device for 6 months. The patients will be contacted at 2 month intervals by an asthma health educator to discuss barriers to adherence to asthma medications
|
|---|---|
|
Degree of Asthma Control
Mean ACT score
|
20.6 score on a scale
Standard Deviation 5.4
|
|
Degree of Asthma Control
Mean cACT score
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23.81 score on a scale
Standard Deviation 3.23
|
SECONDARY outcome
Timeframe: 6 monthsMeasured via questionnaire data obtained every 2 months. Reported at 6 months.
Outcome measures
| Measure |
Single Arm
n=34 Participants
Patients will have adherence monitoring devices placed on their asthma inhalers (both daily and rescue medication). Adherence information will be sent to their PCP, specialist and school nurse monthly. Additionally, the navigator will speak with families every 2 months to discuss adherence data and address barriers.
Propeller Health device + asthma navigator: The patients will be monitored using the propeller health device for 6 months. The patients will be contacted at 2 month intervals by an asthma health educator to discuss barriers to adherence to asthma medications
|
|---|---|
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Barriers to Adherence of Patient Asthma Inhalers
Forgot
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15 Participants
|
|
Barriers to Adherence of Patient Asthma Inhalers
Felt child was better
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3 Participants
|
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Barriers to Adherence of Patient Asthma Inhalers
Thought child didn't need it
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2 Participants
|
|
Barriers to Adherence of Patient Asthma Inhalers
Afraid inhaler could lead to addiction
|
1 Participants
|
|
Barriers to Adherence of Patient Asthma Inhalers
Afraid inhaler could damage child
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1 Participants
|
|
Barriers to Adherence of Patient Asthma Inhalers
Side effects of inhaler
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1 Participants
|
|
Barriers to Adherence of Patient Asthma Inhalers
Inhaler not helping child
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1 Participants
|
|
Barriers to Adherence of Patient Asthma Inhalers
Didn't understand doctor's instructions
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0 Participants
|
|
Barriers to Adherence of Patient Asthma Inhalers
Thought method of application was too complicated
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0 Participants
|
|
Barriers to Adherence of Patient Asthma Inhalers
Child not cooperating with administration
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4 Participants
|
|
Barriers to Adherence of Patient Asthma Inhalers
Inhaler empty
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4 Participants
|
|
Barriers to Adherence of Patient Asthma Inhalers
Other reasons
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16 Participants
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SECONDARY outcome
Timeframe: 6 monthsmeasured via survey to providers at the end of the intervention
Outcome measures
| Measure |
Single Arm
n=4 Participants
Patients will have adherence monitoring devices placed on their asthma inhalers (both daily and rescue medication). Adherence information will be sent to their PCP, specialist and school nurse monthly. Additionally, the navigator will speak with families every 2 months to discuss adherence data and address barriers.
Propeller Health device + asthma navigator: The patients will be monitored using the propeller health device for 6 months. The patients will be contacted at 2 month intervals by an asthma health educator to discuss barriers to adherence to asthma medications
|
|---|---|
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Effectiveness of Communication Between Providers
Communication increased due to study
|
1 Participants
|
|
Effectiveness of Communication Between Providers
Communicated with other providers once or twice
|
4 Participants
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Adverse Events
Single Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place