Breathing Counts: Evaluating Adherence in the Presence of Asthma Navigation Support

Study Overview
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Brief Summary
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To determine if an asthma navigator is helpful in improving communication between care providers and improving patient adherence to asthma medications after an asthma exacerbation.

Detailed Description
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This study will aim to use technology to evaluate the effectiveness of a patient navigator for childhood asthma. The Investigators will place adherence monitoring devices on patient inhalers, and track use of patient asthma medicines. The Investigators will also utilize an asthma navigator who will discuss adherence with families and help to address any barriers to adherence that families identify. Additionally, the navigator will communicate patient specific adherence information to the patient's primary care physician (PCP) and school nurse. The adherence monitor will monitor communications between these providers.

Official Title
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Breathing Counts: Evaluating Adherence in the Presence of Asthma Navigation Support

Conditions
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Asthma

Intervention / Treatment
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* Device: Propeller Health device + asthma navigator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 6-17 years old, Admission to Children's Hospital Colorado with an asthma exacerbation between Jan 1 2017 and Dec 31 2017. Exclusion Criteria: Language other than English or Spanish (application for monitoring adherence is only available in these languages) Presence of other complex medical problems including: Cystic Fibrosis, Tracheostomy/ventilator dependence, other severe chronic lung disease, and significant developmental delays. Home schooled or not in school Following up with an allergy or pulmonary provider outside the CHCO system after hospital discharge.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br>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. | Device: Propeller Health device + asthma navigator<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Adherence of Use of Patient Asthma Inhalers | 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. | Week 1 to Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of Asthma Control | 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 | 6 months | 
| Barriers to Adherence of Patient Asthma Inhalers | Measured via questionnaire data obtained every 2 months. Reported at 6 months. | 6 months | 
| Effectiveness of Communication Between Providers | measured via survey to providers at the end of the intervention | 6 months |